<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01729728</url>
  </required_header>
  <id_info>
    <org_study_id>KF5503/68</org_study_id>
    <secondary_id>2013-002016-27</secondary_id>
    <nct_id>NCT01729728</nct_id>
  </id_info>
  <brief_title>Pharmacokinetic, Efficacy and Safety Study of Tapentadol Oral Solution in Children With Postoperative Pain</brief_title>
  <official_title>Open-label Evaluation of the Pharmacokinetic Profile, Safety, and Efficacy of Tapentadol Oral Solution for the Treatment of Post-surgical Pain in Children and Adolescents Aged From 2 Years to Less Than 18 Years.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Grünenthal GmbH</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Janssen Research &amp; Development, LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Grünenthal GmbH</source>
  <brief_summary>
    <textblock>
      To find out if a drug called tapentadol administered by mouth safely relieves pain in&#xD;
      children. Look at the amount of tapentadol in the blood after a single oral dose.&#xD;
&#xD;
      Tapentadol oral solution for children is still being tested and is not yet registered.&#xD;
      Tapentadol tablets are effective in treating both acute and chronic pain in adults. This&#xD;
      trial will help to understand how tapentadol oral solution works in children.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The lower age limit for the clinical trial was initially set to 3 years of age in the&#xD;
      protocol. The trial planned for the inclusion of participants in three age categories. Age 3&#xD;
      to less than 6 years (young children), age 6 to less than 12 years (older children) and age&#xD;
      12 to less than 18 years of age (adolescents). There was a request by the Paediatric&#xD;
      Committee (PDCO) at the European Medicines Agency to include participants 2 years of age&#xD;
      (very young children). The protocol amendment thus planned to combine the two youngest age&#xD;
      groups into a single reporting group. The protocol amendment only planned that the very young&#xD;
      children group would have separate analysis for the Faces Pain Scale Revised (FPS-R) Scale&#xD;
      and for the presentation of the serum concentrations, because the pharmacokinetic sampling&#xD;
      scheme used in the 2 year old participants was different from the young children group (aged&#xD;
      3 to less than 6 years).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">February 2014</completion_date>
  <primary_completion_date type="Actual">February 2014</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pharmacokinetic Profile of Serum Concentrations of Tapentadol After a Single Dose of Tapentadol Oral Solution in Adolescents (Age 12 to Less Than 18 Years).</measure>
    <time_frame>up to 15 hours</time_frame>
    <description>Mean and Standard Deviation of Serum Concentrations of Tapentadol. Serum was analyzed by means of liquid chromatography coupled to tandem mass spectrometry with a lower limit of quantification (LLOQ) at 0.2 ng/mL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetic Profile of Serum Concentrations of Tapentadol-O-glucuronide After a Single Dose of Tapentadol Oral Solution in Adolescents (Age 12 to Less Than 18 Years).</measure>
    <time_frame>up to 15 hours</time_frame>
    <description>Mean and Standard Deviation of Serum Concentrations of Tapentadol-O-glucuronide. Tapentadol-O-glucuronide is the metabolite of tapentadol. Metabolites are sometimes referred to as &quot;breakdown products&quot;. The body alters the administered medication to a metabolite so that it can be more easily or quickly removed from the body. Tapentadol-O-glucuronide concentrations were measured in participants. Serum was analyzed by means of liquid chromatography coupled to tandem mass spectrometry with a lower limit of quantification (LLOQ) at 10 ng/mL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetic Profile of Serum Concentrations of Tapentadol After a Single Dose of Tapentadol Oral Solution in Older Children (Age 6 to Less Than 12 Years).</measure>
    <time_frame>up to 15 hours</time_frame>
    <description>Mean and Standard Deviation of Serum Concentrations of Tapentadol. Serum was analyzed by means of liquid chromatography coupled to tandem mass spectrometry with a lower limit of quantification (LLOQ) at 0.2 ng/mL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetic Profile of Serum Concentrations of Tapentadol-O-glucuronide After a Single Dose of Tapentadol Oral Solution in Older Children (Age 6 to Less Than 12 Years).</measure>
    <time_frame>up to 15 hours</time_frame>
    <description>Mean and Standard Deviation of Serum Concentrations of Tapentadol-O-glucuronide. Tapentadol-O-glucuronide is the metabolite of tapentadol. Metabolites are sometimes referred to as &quot;breakdown products&quot;. The body alters the administered medication to a metabolite so that it can be more easily or quickly removed from the body. Tapentadol-O-glucuronide concentrations were measured in participants. Serum was analyzed by means of liquid chromatography coupled to tandem mass spectrometry with a lower limit of quantification (LLOQ) at 10 ng/mL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetic Profile of Serum Concentrations of Tapentadol After a Single Dose of Tapentadol Oral Solution in Younger Children (Age 3 to Less Than 6 Years).</measure>
    <time_frame>up to 15 hours</time_frame>
    <description>Mean and Standard Deviation of Serum Concentrations of Tapentadol. Serum was analyzed by means of liquid chromatography coupled to tandem mass spectrometry with a lower limit of quantification (LLOQ) at 0.2 ng/mL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetic Profile of Serum Concentrations of Tapentadol-O-glucuronide After a Single Dose of Tapentadol Oral Solution in Younger Children (Age 3 to Less Than 6 Years).</measure>
    <time_frame>up to 15 hours</time_frame>
    <description>Mean and Standard Deviation of Serum Concentrations of Tapentadol-O-glucuronide. Tapentadol-O-glucuronide is the metabolite of tapentadol. Metabolites are sometimes referred to as &quot;breakdown products&quot;. The body alters the administered medication to a metabolite so that it can be more easily or quickly removed from the body. Tapentadol-O-glucuronide concentrations were measured in participants. Serum was analyzed by means of liquid chromatography coupled to tandem mass spectrometry with a lower limit of quantification (LLOQ) at 10 ng/mL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetic Profile of Serum Concentrations of Tapentadol After a Single Dose of Tapentadol Oral Solution in Very Young Children (Age 2 to Less Than 3 Years).</measure>
    <time_frame>up to 15 hours</time_frame>
    <description>Mean and Standard Deviation of Serum Concentrations of Tapentadol. Serum was analyzed by means of liquid chromatography coupled to tandem mass spectrometry with a lower limit of quantification (LLOQ) at 0.2 ng/mL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetic Profile of Serum Concentrations of Tapentadol-O-glucuronide After a Single Dose of Tapentadol Oral Solution in Very Young Children (Age 2 to Less Than 3 Years).</measure>
    <time_frame>up to 15 hours</time_frame>
    <description>Mean and Standard Deviation of Serum Concentrations of Tapentadol-O-glucuronide. Tapentadol-O-glucuronide is the metabolite of tapentadol. Metabolites are sometimes referred to as &quot;breakdown products&quot;. The body alters the administered medication to a metabolite so that it can be more easily or quickly removed from the body. Tapentadol-O-glucuronide concentrations were measured in participants. Serum was analyzed by means of liquid chromatography coupled to tandem mass spectrometry with a lower limit of quantification (LLOQ) at 10 ng/mL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Non-Compartmental Pharmacokinetic (PK) Parameter of Tapentadol Area Under the Concentration-Time Curve (AUC 0-15) After a Single Dose of Tapentadol in Adolescent Participants (Age 12 to Less Than 18 Years).</measure>
    <time_frame>up to 15 hours</time_frame>
    <description>Serum samples for pharmacokinetic analysis were obtained using frequent sampling techniques in participants 12 years to less than 18 years of age.&#xD;
Serum samples (frequent sampling) were drawn at 0.25, 0.5, 1, 2, 4, 6, 11, and 15 hours.&#xD;
The Area Under the Curve (AUC) from dose to 15 hours (AUC 0-15) is a summary measure of data from each pharmacokinetic blood sample taken over the 15 hour time period.&#xD;
The area is that below the line fitted to the data points.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Non-Compartmental Pharmacokinetic (PK) Parameter: Cmax (Maximum Concentration) of Tapentadol After a Single Dose of Tapentadol in Adolescents (Age 12 to Less Than 18 Years).</measure>
    <time_frame>up to 15 hours</time_frame>
    <description>Serum samples for pharmacokinetic analysis were obtained using frequent sampling techniques in participants 12 years to less than 18 years of age.&#xD;
Serum samples (frequent sampling) were drawn at 0.25, 0.5, 1, 2, 4, 6, 11, and 15 hours. The concentration of tapentadol (active drug) is assessed during absorption and distribution.&#xD;
The maximum concentration is derived from the Area Under the Curve, from dose to 15 hours (AUC 0-15). It is the highest amount of active drug observed in the blood sample</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Non-Compartmental Pharmacokinetic (PK) Parameter: Time to Maximum Concentration (Tmax) of Tapentadol After a Single Dose of Tapentadol in Adolescents (Age 12 to Less Than 18 Years).</measure>
    <time_frame>up to 15 hours</time_frame>
    <description>Serum samples for pharmacokinetic analysis were obtained using frequent sampling techniques in participants 12 years to less than 18 years of age.&#xD;
The time to maximum concentration is derived from the area under the curve from dose to 15 hours (AUC 0-15). The Tmax is the time after dosing at which the maximum concentration of the tapentadol (active drug) occurs.&#xD;
Serum samples (frequent sampling) were drawn at 0.25, 0.5, 1, 2, 4, 6, 11, and 15 hours.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Non-Compartmental Pharmacokinetic (PK) Parameter of Tapentadol-O-glucuronide Area Under the Concentration-Time Curve (AUC 0-15) After a Single Dose of Tapentadol in Adolescents (Age 12 to Less Than 18 Years).</measure>
    <time_frame>up to 15 hours</time_frame>
    <description>Serum samples for pharmacokinetic analysis were obtained using frequent sampling techniques in participants 12 years to less than 18 years of age.&#xD;
Serum samples (frequent sampling) were drawn at 0.25, 0.5, 1, 2, 4, 6, 11, and 15 hours. The concentration of tapentadol (active drug) is assessed during absorption and distribution.&#xD;
The maximum concentration is derived from the Area Under the Curve, from dose to 15 hours (AUC 0-15). It is the highest amount of active drug observed in the blood sample.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Non-Compartmental Pharmacokinetic (PK) Parameter: Cmax (Maximum Concentration) of Tapentadol-O-glucuronide After a Single Dose of Tapentadol in Adolescents (Age 12 to Less Than 18 Years).</measure>
    <time_frame>up to 15 hours</time_frame>
    <description>Tapentadol-O-glucuronide is the metabolite of tapentadol. Metabolites are sometimes referred to as &quot;breakdown products&quot;. The body alters the administered medication to a metabolite so that it can be more easily or quickly removed from the body. Serum samples (frequent sampling) were drawn at 0.25, 0.5, 1, 2, 4, 6, 11, and 15 hours. The concentration of tapentadol-O-glucuronide (metabolite) is assessed to study absorption and distribution.&#xD;
The maximum concentration is derived from the Area Under the Curve, from dose to 15 hours (AUC 0-15). It is the highest amount of metabolite observed in the blood sample.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Non-Compartmental Pharmacokinetic (PK) Parameter: Time to Maximum Concentration (Tmax) of Tapentadol-O-glucuronide After a Single Dose of Tapentadol in Adolescents (Age 12 to Less Than 18).</measure>
    <time_frame>up to 15 hours</time_frame>
    <description>Tapentadol-O-glucuronide is the metabolite of tapentadol. Metabolites are sometimes referred to as &quot;breakdown products&quot;. The body alters the administered medication to a metabolite so that it can be more easily or quickly removed from the body. Serum samples for pharmacokinetic analysis were obtained using frequent sampling techniques in participants 12 years to less than 18 years of age. The time to maximum concentration is derived from the area under the curve from dose to 15 hours (AUC 0-15). The Tmax is the time after dosing at which the maximum concentration of the tapentadol-O-glucuronide (metabolite) occurs. Serum samples (frequent sampling) were drawn at 0.25, 0.5, 1, 2, 4, 6, 11, and 15 hours.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain Intensity Assessments Using the Visual Analog Scale (VAS) in Adolescents (Age 12 to Less Than 18 Years).</measure>
    <time_frame>Baseline; 15 hours</time_frame>
    <description>At predefined times after investigational medicinal product administration, participants were asked to rate their pain on a 100 mm line (visual analog scale - VAS) by marking a point on the line in response to:&#xD;
&quot;My pain at this time is&quot;. The mark was scored between &quot;no pain&quot; and &quot; pain as bad as it could be&quot;. The distance was then measured by a clinician and reported.&#xD;
A value of 0 indicates &quot;no pain&quot;. A value of 100 indicates &quot;pain as bad as it could be&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Intensity Assessments Using the McGrath Color Analog Scale in Adolescent Participants and Older Children (Age 6 to Less Than 18 Years).</measure>
    <time_frame>Baseline; 15 hours post-dose</time_frame>
    <description>Pain intensity assessments were with a 0 (no pain) to 10 (worst pain) scored McGrath color analog scale (CAS) in participants aged 6 years to less than 18 years, i.e. in Adolescents and Older Children. Participants were presented with the CAS and instructed to place the sliding bar on the color that best represented their pain intensity level at the time of assessment. The CAS is a pocket size tool used to measure the self-reported pain intensity of the older participants. The CAS consists of a 145 mm long triangular shaped strip of plastic, varying in width and hue from 1 mm wide and light pink hue at the bottom (and text no pain), to 3 mm wide and deep red hue at the top (most pain). This instrument includes 2 sides. One side shows the color pain intensity scale as described and the other shows a graduated scale, which provides a specific numeric value for the participant-reported level of pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Intensity Assessments Using the Faces Pain Scale (Revised) in Children Age 3 to Less Than 12 Years.</measure>
    <time_frame>Baseline; 15 hours post-dose</time_frame>
    <description>This assessment tool was used in 3 to less than 12 year old participants, i.e. Older Children and Young Children.&#xD;
The Faces Pain Scale (Revised) [FPS-R] score as allocated to a selected face by the participant. There are 6 faces and the participant is asked to indicate on a face to express how much it hurts.&#xD;
The numeric value 0 (no pain) to 10 (very much pain) is read off the reverse side of the scale by the clinician.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Intensity Assessment Using the Face, Legs, Activity, Cry, Consolability Scale in Young and Very Young Children (Age 2 to Less Than 6 Years).</measure>
    <time_frame>Baseline; 15 hours post-dose</time_frame>
    <description>The Face Legs Activity Cry Consolability (FLACC) Scale was developed by the Department of Anesthesiology, University of Michigan Medical School and Health Systems. The FLACC Scale is a behavioral scale for scoring postoperative pain in children between the ages of two months and seven years or in persons unable to communicate. In this trial the scale was used in the young and very young children, i.e. in participants aged 2 to less than 6 years. This tool includes five categories of pain behaviors, including facial expression, leg movement, activity, cry, and consolability. The clinician observes the participant for 5 minutes or more and scores each category with a 0, 1 or 2. The scores are added together for a total score ranging from 0 (no pain) to 10 (worst pain). The higher the total score the higher the pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sum of Pain Intensity Differences Over the 4 Hours After Dosing Derived From the Different Pain Scales and for All Age Groups</measure>
    <time_frame>Baseline; 4 hours post-dose</time_frame>
    <description>Different pain intensity assessment tools were used in the different age groups. Therefore the sum of pain intensities were calculated and are reported for each age group based on the tool used.&#xD;
Adolescents - Age 12 to Less Than 18 Years.&#xD;
Older Children - Age 6 to Less Than 12 Years.&#xD;
Young Children - Age 3 to Less Than 6 Years.&#xD;
Very Young Children - Age 2 to Less Than 3 Years.&#xD;
CAS (McGrath color analog scale) [Theoretical Range: -40 to + 40],&#xD;
VAS (100 mm Visual Analog Scale) [Theoretical Range: -400 to + 400],&#xD;
FPS-R (6-point Faces Pain Scale - Revised) [Theoretical Range: -40 to + 40],&#xD;
FLACC (Face, Legs, Activity, Cry, and Consolability score) [Theoretical Range: -40 to + 40].&#xD;
A mean score of zero indicates that there was no pain intensity change over the 4 hours.&#xD;
The positive values indicate that in the group as a whole the sum of all pain intensity values over the first 4 hours lead to a reduction in pain in the time period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Respiratory Rate Assessments</measure>
    <time_frame>Enrollment Visit; 15 hours post-dose</time_frame>
    <description>Respiratory rate assessments were performed at pre-defined times during the 15 hour period following investigational medicinal product intake.&#xD;
Pre-surgery data for these participants is also given from the enrollment Visit (Visit 1).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxygen Saturation Assessments</measure>
    <time_frame>Enrollment Visit; 15 hours post-dose</time_frame>
    <description>Oxygen saturation assessments were performed at pre-defined times during the 15 hour period following investigational medicinal product intake.&#xD;
Oxygen saturation was assessed using pulse oximetry. The uppermost value is 100%.&#xD;
Pre-surgery data for these participants is also given from the enrollment Visit (Visit 1).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systolic and Diastolic Blood Pressure Assessments</measure>
    <time_frame>Enrollment Visit; 15 hours post-dose</time_frame>
    <description>Systolic and Diastolic blood pressure assessments were performed at pre-defined times during the 15 hour period following investigational medicinal product intake.&#xD;
Pre-surgery data for these participants is also given from the enrollment Visit (Visit 1).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Enrollment in 12-lead Electrocardiogram Parameters</measure>
    <time_frame>Enrollment (pre-surgery); Discharge Visit</time_frame>
    <description>12-lead electrocardiograms (ECG) were part of the planned safety assessments. 12-lead Electrocardiograms were performed prior at the enrollment visit after informed consent and at the discharge visit. The discharge visit was as per standard of care.&#xD;
The changes in ECG parameters are reported. Negative mean values indicate that the millisecond intervals decreased from the enrollment to the discharge visit. Positive mean values indicate that the millisecond intervals increased from the enrollment to the discharge visit. The Letters P,Q,R,S and T refer to specific medically defined points on an ECG tracing and correspond to specific heart activities.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Enrollment in 12-lead Electrocardiogram Heart Rate Parameter</measure>
    <time_frame>Enrollment; Discharge Visit</time_frame>
    <description>12-lead Electrocardiograms (ECG) were part of the planned safety assessments. 12-lead Electrocardiograms were performed prior at the enrollment visit after informed consent and at the discharge visit. The discharge visit was as per standard of care.&#xD;
The changes in heart rate (beats per minute) parameters are reported per treatment group between the visits.&#xD;
A positive value indicates that the heart rate was higher at discharge than at enrollment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment Emergent Adverse Events by Intensity</measure>
    <time_frame>Baseline; 48 hours post dosing</time_frame>
    <description>The intensity of all treatment emergent adverse events (TEAEs) were scored by the investigator. Treatment emergent adverse events were those adverse events documented from the time of investigational medicinal product (IMP), study drug, up to 48 hours post dosing.&#xD;
The clinical &quot;intensity&quot; of an adverse event was classified as:&#xD;
Mild: Signs and symptoms that can be easily tolerated. Symptoms can be ignored and disappear when the subject is distracted.&#xD;
Moderate: Symptoms cause discomfort but are tolerable; they cannot be ignored and affect concentration.&#xD;
Severe: Symptoms which affect usual daily activity.&#xD;
For adverse events where the intensity changes over time, the maximum intensity observed was documented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intake of Additional Analgesic Medication During the Trial</measure>
    <time_frame>Baseline; 15 hours post dosing</time_frame>
    <description>Number of participants with intakes of supplemental analgesic medication between investigational medicinal product (IMP) intake and Site Discharge grouped according to preparation taken (non-opioid/opioid).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hematology Safety Laboratory Assessments: Hemoglobin Concentration</measure>
    <time_frame>Enrollment Visit; Visit 2 and Discharge Visit</time_frame>
    <description>The hemoglobin test is a commonly ordered blood test and was done as part of a complete blood count (CBC). It is routinely done before and after surgery to check for anemia, the presence of chronic kidney disease or other chronic medical problems. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hematology Safety Laboratory Assessments: Hematocrit</measure>
    <time_frame>Enrollment Visit; Visit 2 and Discharge Visit</time_frame>
    <description>Hematocrit is a blood test that measures the percentage of the volume of whole blood that is made up of red blood cells (RBC). This measurement depends on the number of red blood cells and the size of red blood cells. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hematology Safety Laboratory Assessments: Erythrocyte Mean Corpuscular Volume (Mean Corpuscular Volume)</measure>
    <time_frame>Enrollment Visit; Visit 2 and Discharge Visit</time_frame>
    <description>Erythrocyte Mean Corpuscular volume is a measurement of the average size of Red Blood Cells (RBC). It is also referred to as Mean Corpuscular Volume. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hematology Safety Laboratory Assessments: Platelet Count</measure>
    <time_frame>Enrollment Visit; Visit 2 and Discharge Visit</time_frame>
    <description>Platelets are cell fragments that are vital for normal blood clotting. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hematology Safety Laboratory Assessments: Leukocyte Concentration</measure>
    <time_frame>Enrollment Visit; Visit 2 and Discharge Visit</time_frame>
    <description>Leukocytes are also called white blood cells (WBC). These were measured to assess immune function. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biochemistry Safety Laboratory Parameters: Blood Glucose Concentration</measure>
    <time_frame>Enrollment Visit; Visit 2 and Discharge Visit</time_frame>
    <description>A blood glucose test measures the amount of a sugar called glucose in blood. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biochemistry Safety Laboratory Parameters: Blood Sodium Concentration</measure>
    <time_frame>Enrollment Visit; Visit 2 and Discharge Visit</time_frame>
    <description>Sodium is required by the body for the body to function properly. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biochemistry Safety Laboratory Parameters: Blood Potassium Concentration</measure>
    <time_frame>Enrollment Visit; Visit 2 and Discharge Visit</time_frame>
    <description>Potassium is a mineral that the body needs to work normally. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biochemistry Safety Laboratory Parameters: Blood Calcium Concentration</measure>
    <time_frame>Enrollment Visit; Visit 2 and Discharge Visit</time_frame>
    <description>All cells need calcium in order to function. In the study there were 3 planned safety blood draws for routine blood tests. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biochemistry Safety Laboratory Parameters: Blood Chloride Concentration</measure>
    <time_frame>Enrollment Visit; Visit 2 and Discharge Visit</time_frame>
    <description>Chloride with other electrolytes help keep the proper balance of body fluids and maintain the body's acid-base balance. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biochemistry Safety Laboratory Parameters: Blood Phosphate Concentration</measure>
    <time_frame>Enrollment Visit; Visit 2 and Discharge Visit</time_frame>
    <description>Phosphate is needed by the body. This test was done to see how much phosphate is in the blood. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biochemistry Safety Laboratory Parameters: Blood Urea Nitrogen (BUN) Concentration</measure>
    <time_frame>Enrollment Visit; Visit 2 and Discharge Visit</time_frame>
    <description>This test is to measure the amount of urea nitrogen in the blood. It was used to test liver and kidney function. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biochemistry Safety Laboratory Parameters: Creatinine Concentration</measure>
    <time_frame>Enrollment Visit; Visit 2 and Discharge Visit</time_frame>
    <description>Creatinine is removed from the body entirely by the kidneys. If kidney function is not normal, creatinine level increases in the blood. In the study there were 3 planned safety blood draws for routine blood tests. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biochemistry Safety Laboratory Parameters: Aspartate Aminotransferase (AST) Enzyme Activity</measure>
    <time_frame>Enrollment Visit; Visit 2 and Discharge Visit</time_frame>
    <description>AST is considered to be one of the two most important tests to detect liver injury. During liver damage the enzyme is released into the blood. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biochemistry Safety Laboratory Parameters: Triglycerides Concentration</measure>
    <time_frame>Enrollment Visit; Visit 2 and Discharge Visit</time_frame>
    <description>Triglycerides are a group of fat. Triglycerides were measured as part of metabolic and cardiac assessments. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biochemistry Safety Laboratory Parameters: Serum Albumin Concentration</measure>
    <time_frame>Enrollment Visit; Visit 2 and Discharge Visit</time_frame>
    <description>Albumin is a protein made by the liver. Albumin prevents fluid leaking into the tissues. Albumin also transports many small molecules. Serum albumin was measured in the clear liquid portion of the blood called serum. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biochemistry Safety Laboratory Parameters: Urate in the Blood</measure>
    <time_frame>Enrollment Visit; Visit 2 and Discharge Visit</time_frame>
    <description>Uric acid (urate is the salt) is a chemical created when the body breaks down substances called purines. Most urate dissolves in blood and travels to the kidneys. From there, it passes out in the urine. The test is used to determine kidney function. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biochemistry Safety Laboratory Parameters: Calculated Glomerular Filtration Rate</measure>
    <time_frame>Enrollment Visit; Visit 2 and Discharge Visit</time_frame>
    <description>Glomerular filtration rate (GFR) was done to check how well the kidneys are working. It estimates how much blood passes through the glomeruli in the kidney each minute. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biochemistry Safety Laboratory Parameters: Urine Specific Gravity</measure>
    <time_frame>Enrollment Visit and Discharge Visit</time_frame>
    <description>This test was used to test for the water balance and urine concentration. A urine sample was tested right away. A dipstick with a color-sensitive pad was used. The color the dipstick changes and the specific gravity of the urine was read off the color chart. In the study there were 2 planned safety urine collections. At Visit 1 in the enrollment period, after consent and assent obtained. The second sample was obtained at Visit 3 prior to discharge from the hospital. The discharge visit was as per standard of care.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biochemistry Safety Laboratory Parameters: Urine pH (Acid, Alkalinity) Test</measure>
    <time_frame>Enrollment Visit and Discharge Visit</time_frame>
    <description>A urine sample was tested right away. A dipstick made with a color-sensitive pad was used. The color indicated the acidity of the urine. In the study there were 2 planned safety urine collections. At Visit 1 in the enrollment period, after consent and assent obtained. The second sample was obtained at Visit 3 prior to discharge from the hospital. The discharge visit was as per standard of care.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biochemistry Safety Laboratory Parameters: Liver Function Test - Alanine Aminotransferase (ALT) Enzyme Activity</measure>
    <time_frame>Enrollment Visit, Visit 2 and Discharge Visit</time_frame>
    <description>This test was done in combination with other tests (such as AST, ALP, and bilirubin) to diagnose and monitor the liver function. In the study there were 3 planned safety blood draws for routine blood tests. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biochemistry Safety Laboratory Parameters: Liver Function Test - Gamma-Glutamyl Transferase (GGT) Enzyme Activity</measure>
    <time_frame>Enrollment Visit, Visit 2 and Discharge Visit</time_frame>
    <description>The gamma-glutamyl transferase (GGT) test was used in combination with the alkaline phosphatase (ALP) test. Both ALP and GGT can be elevated in bile duct or liver complications. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biochemistry Safety Laboratory Parameters: Liver Function Test - Bilirubin Concentration</measure>
    <time_frame>Enrollment Visit, Visit 2 and Discharge Visit</time_frame>
    <description>Old red blood cells are replaced by new blood cells every day. Bilirubin is made by the body when the old blood cells are removed. The concentration of bilirubin in the blood measures liver function. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biochemistry Safety Laboratory Parameters: Liver Function Test - Lactate Dehydrogenase (LDH) Enzyme Activity</measure>
    <time_frame>Enrollment Visit, Visit 2 and Discharge Visit</time_frame>
    <description>Lactate Dehydrogenase (LDH) was used to check for tissue damage. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biochemistry Safety Laboratory Parameters: Blood Protein Concentration</measure>
    <time_frame>Enrollment Visit, Visit 2 and Discharge Visit</time_frame>
    <description>The test was done to verify kidney and liver function. It is done in combination with the albumin test. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biochemistry Safety Laboratory Parameters: Creatine Kinase (CK) Enzyme Activity</measure>
    <time_frame>Enrollment Visit, Visit 2 and Discharge Visit</time_frame>
    <description>The creatine kinase (CK) test was used to detect inflammation of muscles. The test was done in combination with other tests. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biochemistry Safety Laboratory Parameters: Alkaline Phosphatase (ALP) Enzyme Activity</measure>
    <time_frame>Enrollment Visit, Visit 2 and Discharge Visit</time_frame>
    <description>The Alkaline Phosphatase activity was used to detect bone or hepatobiliary disease. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biochemistry Safety Laboratory Parameters: Triacylglycerol Lipase (TL) Enzyme Activity</measure>
    <time_frame>Enrollment Visit, Visit 2 and Discharge Visit</time_frame>
    <description>A triacylglycerol lipase test was done to check for pancreatic function. In the study there were 3 planned safety blood draws for routine blood tests. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to investigational medicinal product administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">86</enrollment>
  <condition>Postoperative Pain</condition>
  <condition>Acute Pain</condition>
  <arm_group>
    <arm_group_label>Tapentadol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tapentadol</intervention_name>
    <description>Tapentadol oral solution single dose (1mg/kg body weight)</description>
    <arm_group_label>Tapentadol</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A maximum body weight of 85.0 kg.&#xD;
&#xD;
          -  A minimum body weight of 10 kg for participants aged 2 years to less than 3 years old.&#xD;
&#xD;
          -  If female and post-menarchal, or 12 years or older, the subject has a negative urine&#xD;
             pregnancy test within 24 hours before surgery.&#xD;
&#xD;
          -  Having completed either dental surgery or tonsillectomy with or without adenoidectomy&#xD;
             surgery (age group: 6 to less than 18 years of age).&#xD;
&#xD;
          -  Having completed ear, nose, or throat surgery (including but not limited to&#xD;
             tonsillectomy (age group: 2 to less than 3 years of age).&#xD;
&#xD;
          -  Participant aged 6 to less than 18 years has a post-operative pain intensity score&#xD;
             greater than or equal to 4 on the Color Analog Scale (CAS) as a result of the surgical&#xD;
             procedure or the participant has a pain level that the usual standard of care&#xD;
             following the surgical procedure (which reliably produces moderate to severe pain)&#xD;
             requires opioid treatment.&#xD;
&#xD;
          -  Participant aged 2 years to less than 6 years has a pain level following a surgical&#xD;
             procedure that reliably produces moderate to severe pain, for which the usual standard&#xD;
             of care requires opioid treatment.&#xD;
&#xD;
          -  Participant is alert, orientated, and able to follow commands and complete the&#xD;
             post-operative required procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of brain injury.&#xD;
&#xD;
          -  Clinically relevant abnormal ECG.&#xD;
&#xD;
          -  Clinically unstable vital signs and/or a saturation of oxygen saturation (SpO2) less&#xD;
             than 93%. During surgery SpO2 may decrease &lt;93%.&#xD;
&#xD;
          -  Clinically relevant abnormal values for clinical chemistry, hematology, or urinalysis&#xD;
             at enrollment.&#xD;
&#xD;
          -  Body temperature above 38.5°C within 48 hours prior to dosing.&#xD;
&#xD;
          -  Positive drugs of abuse test result.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Grünenthal GmbH</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Jean Brown Research</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84124</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Muse D, Tarau E, Lefeber C, Sohns M, Brett M, Goldberg J, Rosenburg R. Pharmacokinetics, safety, and efficacy of tapentadol oral solution for treating moderate to severe pain in pediatric patients. J Pain Res. 2019 May 31;12:1777-1790. doi: 10.2147/JPR.S197039. eCollection 2019.</citation>
    <PMID>31213888</PMID>
  </results_reference>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>November 6, 2012</study_first_submitted>
  <study_first_submitted_qc>November 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 20, 2012</study_first_posted>
  <results_first_submitted>September 9, 2014</results_first_submitted>
  <results_first_submitted_qc>November 20, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">November 27, 2014</results_first_posted>
  <last_update_submitted>October 18, 2019</last_update_submitted>
  <last_update_submitted_qc>October 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Tonsillectomy</keyword>
  <keyword>Dental surgery</keyword>
  <keyword>Ear surgery</keyword>
  <keyword>Nose surgery</keyword>
  <keyword>Throat surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
    <mesh_term>Acute Pain</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tapentadol</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The first participant was enrolled on the 15 Nov 2012 and the last participant completed the trial on the 24 Feb 2014.</recruitment_details>
      <pre_assignment_details>Consent was obtained for 86 participants in the trial. 66 participants were allocated and received study drug (investigational medicinal product). Pharmacokinetic data was obtained for the planned 56 participants.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Adolescents</title>
          <description>Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight)</description>
        </group>
        <group group_id="P2">
          <title>Older Children</title>
          <description>Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight)</description>
        </group>
        <group group_id="P3">
          <title>Young and Very Young Children</title>
          <description>Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="28"/>
                <participants group_id="P3" count="17"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="22"/>
                <participants group_id="P3" count="16"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Number of participants that were dosed.</population>
      <group_list>
        <group group_id="B1">
          <title>Adolescents</title>
          <description>Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
        </group>
        <group group_id="B2">
          <title>Older Children</title>
          <description>Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
        </group>
        <group group_id="B3">
          <title>Young and Very Young Children</title>
          <description>Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="21"/>
            <count group_id="B2" value="28"/>
            <count group_id="B3" value="17"/>
            <count group_id="B4" value="66"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15.5" spread="1.6"/>
                    <measurement group_id="B2" value="8.3" spread="1.6"/>
                    <measurement group_id="B3" value="3.4" spread="1.1"/>
                    <measurement group_id="B4" value="9.3" spread="4.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="34"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="63"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="17"/>
                    <measurement group_id="B4" value="66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>kilograms</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61.30" spread="9.78"/>
                    <measurement group_id="B2" value="28.85" spread="5.89"/>
                    <measurement group_id="B3" value="16.34" spread="2.20"/>
                    <measurement group_id="B4" value="35.95" spread="19.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height</title>
          <units>centimeter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="170.6" spread="10.7"/>
                    <measurement group_id="B2" value="132.9" spread="11.1"/>
                    <measurement group_id="B3" value="101.7" spread="8.1"/>
                    <measurement group_id="B4" value="136.9" spread="28.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Pharmacokinetic Profile of Serum Concentrations of Tapentadol After a Single Dose of Tapentadol Oral Solution in Adolescents (Age 12 to Less Than 18 Years).</title>
        <description>Mean and Standard Deviation of Serum Concentrations of Tapentadol. Serum was analyzed by means of liquid chromatography coupled to tandem mass spectrometry with a lower limit of quantification (LLOQ) at 0.2 ng/mL.</description>
        <time_frame>up to 15 hours</time_frame>
        <population>Pharmacokinetic Set</population>
        <group_list>
          <group group_id="O1">
            <title>Tapentadol Serum Concentrations: Adolescents</title>
            <description>Tapentadol oral solution single dose (1mg/kg body weight). Participants aged 12 years and less than 18 years of age.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetic Profile of Serum Concentrations of Tapentadol After a Single Dose of Tapentadol Oral Solution in Adolescents (Age 12 to Less Than 18 Years).</title>
          <description>Mean and Standard Deviation of Serum Concentrations of Tapentadol. Serum was analyzed by means of liquid chromatography coupled to tandem mass spectrometry with a lower limit of quantification (LLOQ) at 0.2 ng/mL.</description>
          <population>Pharmacokinetic Set</population>
          <units>nanogram per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>15 minutes post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.2" spread="34.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 minutes post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.6" spread="33.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 hour post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49.4" spread="21.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 hours post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.1" spread="14.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 hours post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.8" spread="10.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 hours post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.3" spread="11.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>11 hours post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.14" spread="6.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 hours post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.66" spread="3.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain Intensity Assessments Using the Visual Analog Scale (VAS) in Adolescents (Age 12 to Less Than 18 Years).</title>
        <description>At predefined times after investigational medicinal product administration, participants were asked to rate their pain on a 100 mm line (visual analog scale - VAS) by marking a point on the line in response to:&#xD;
&quot;My pain at this time is&quot;. The mark was scored between &quot;no pain&quot; and &quot; pain as bad as it could be&quot;. The distance was then measured by a clinician and reported.&#xD;
A value of 0 indicates &quot;no pain&quot;. A value of 100 indicates &quot;pain as bad as it could be&quot;.</description>
        <time_frame>Baseline; 15 hours</time_frame>
        <population>Protocol pre-specified reporting groups.</population>
        <group_list>
          <group group_id="O1">
            <title>Visual Analog Scale: Adolescents</title>
            <description>Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Intensity Assessments Using the Visual Analog Scale (VAS) in Adolescents (Age 12 to Less Than 18 Years).</title>
          <description>At predefined times after investigational medicinal product administration, participants were asked to rate their pain on a 100 mm line (visual analog scale - VAS) by marking a point on the line in response to:&#xD;
&quot;My pain at this time is&quot;. The mark was scored between &quot;no pain&quot; and &quot; pain as bad as it could be&quot;. The distance was then measured by a clinician and reported.&#xD;
A value of 0 indicates &quot;no pain&quot;. A value of 100 indicates &quot;pain as bad as it could be&quot;.</description>
          <population>Protocol pre-specified reporting groups.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71.5" spread="13.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 minutes post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63.6" spread="24.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 minutes post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.2" spread="27.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 hour post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.3" spread="26.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 hours post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.0" spread="24.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 hours post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.5" spread="26.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 hours post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.8" spread="24.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>11 hours post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.7" spread="21.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 hours post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.4" spread="20.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain Intensity Assessments Using the McGrath Color Analog Scale in Adolescent Participants and Older Children (Age 6 to Less Than 18 Years).</title>
        <description>Pain intensity assessments were with a 0 (no pain) to 10 (worst pain) scored McGrath color analog scale (CAS) in participants aged 6 years to less than 18 years, i.e. in Adolescents and Older Children. Participants were presented with the CAS and instructed to place the sliding bar on the color that best represented their pain intensity level at the time of assessment. The CAS is a pocket size tool used to measure the self-reported pain intensity of the older participants. The CAS consists of a 145 mm long triangular shaped strip of plastic, varying in width and hue from 1 mm wide and light pink hue at the bottom (and text no pain), to 3 mm wide and deep red hue at the top (most pain). This instrument includes 2 sides. One side shows the color pain intensity scale as described and the other shows a graduated scale, which provides a specific numeric value for the participant-reported level of pain.</description>
        <time_frame>Baseline; 15 hours post-dose</time_frame>
        <population>Protocol pre-specified reporting groups.</population>
        <group_list>
          <group group_id="O1">
            <title>McGrath Color Analog Scale: Adolescents</title>
            <description>Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
          <group group_id="O2">
            <title>McGrath Color Analog Scale: Older Children</title>
            <description>Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Intensity Assessments Using the McGrath Color Analog Scale in Adolescent Participants and Older Children (Age 6 to Less Than 18 Years).</title>
          <description>Pain intensity assessments were with a 0 (no pain) to 10 (worst pain) scored McGrath color analog scale (CAS) in participants aged 6 years to less than 18 years, i.e. in Adolescents and Older Children. Participants were presented with the CAS and instructed to place the sliding bar on the color that best represented their pain intensity level at the time of assessment. The CAS is a pocket size tool used to measure the self-reported pain intensity of the older participants. The CAS consists of a 145 mm long triangular shaped strip of plastic, varying in width and hue from 1 mm wide and light pink hue at the bottom (and text no pain), to 3 mm wide and deep red hue at the top (most pain). This instrument includes 2 sides. One side shows the color pain intensity scale as described and the other shows a graduated scale, which provides a specific numeric value for the participant-reported level of pain.</description>
          <population>Protocol pre-specified reporting groups.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.643" spread="1.461"/>
                    <measurement group_id="O2" value="4.670" spread="1.602"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 minutes post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.131" spread="2.180"/>
                    <measurement group_id="O2" value="3.071" spread="1.718"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 minutes after dosing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.262" spread="2.311"/>
                    <measurement group_id="O2" value="2.571" spread="1.824"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 hour post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.393" spread="2.299"/>
                    <measurement group_id="O2" value="2.407" spread="1.723"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 hours post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.475" spread="2.173"/>
                    <measurement group_id="O2" value="2.292" spread="1.793"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 hours post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.200" spread="2.113"/>
                    <measurement group_id="O2" value="2.341" spread="1.899"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 hours post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.438" spread="1.960"/>
                    <measurement group_id="O2" value="2.636" spread="2.152"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>11 hours post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.350" spread="1.836"/>
                    <measurement group_id="O2" value="3.352" spread="1.851"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 hours post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.288" spread="1.578"/>
                    <measurement group_id="O2" value="3.568" spread="2.549"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain Intensity Assessments Using the Faces Pain Scale (Revised) in Children Age 3 to Less Than 12 Years.</title>
        <description>This assessment tool was used in 3 to less than 12 year old participants, i.e. Older Children and Young Children.&#xD;
The Faces Pain Scale (Revised) [FPS-R] score as allocated to a selected face by the participant. There are 6 faces and the participant is asked to indicate on a face to express how much it hurts.&#xD;
The numeric value 0 (no pain) to 10 (very much pain) is read off the reverse side of the scale by the clinician.</description>
        <time_frame>Baseline; 15 hours post-dose</time_frame>
        <population>The protocol pre-specified that the Faces Pain Scale (Revised) would not be administered in the very young participants (aged 2 to less than 3 years).</population>
        <group_list>
          <group group_id="O1">
            <title>Faces Pain Scale: Older Children</title>
            <description>Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight)</description>
          </group>
          <group group_id="O2">
            <title>Faces Pain Scale: Young Children</title>
            <description>Single Dose of Tapentadol Oral Solution in Children Age 3 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight). The children aged 2 were assessed using the FLACC (Face, Legs, Activity, Cry, Consolability) Scale and not the 6-point Faces Pain Scale - Revised.</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Intensity Assessments Using the Faces Pain Scale (Revised) in Children Age 3 to Less Than 12 Years.</title>
          <description>This assessment tool was used in 3 to less than 12 year old participants, i.e. Older Children and Young Children.&#xD;
The Faces Pain Scale (Revised) [FPS-R] score as allocated to a selected face by the participant. There are 6 faces and the participant is asked to indicate on a face to express how much it hurts.&#xD;
The numeric value 0 (no pain) to 10 (very much pain) is read off the reverse side of the scale by the clinician.</description>
          <population>The protocol pre-specified that the Faces Pain Scale (Revised) would not be administered in the very young participants (aged 2 to less than 3 years).</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.8" spread="1.6"/>
                    <measurement group_id="O2" value="6.8" spread="3.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 minutes post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.5" spread="1.8"/>
                    <measurement group_id="O2" value="4.5" spread="4.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 minutes post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.9" spread="1.8"/>
                    <measurement group_id="O2" value="2.8" spread="3.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 hour post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.4" spread="1.6"/>
                    <measurement group_id="O2" value="1.8" spread="3.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 hours post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.6" spread="1.7"/>
                    <measurement group_id="O2" value="1.2" spread="2.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 hours post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5" spread="1.6"/>
                    <measurement group_id="O2" value="3.5" spread="3.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 hours post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.7" spread="2.1"/>
                    <measurement group_id="O2" value="1.8" spread="2.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>11 hours post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.7" spread="1.7"/>
                    <measurement group_id="O2" value="2.3" spread="2.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 hours post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.5" spread="2.2"/>
                    <measurement group_id="O2" value="2.8" spread="2.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain Intensity Assessment Using the Face, Legs, Activity, Cry, Consolability Scale in Young and Very Young Children (Age 2 to Less Than 6 Years).</title>
        <description>The Face Legs Activity Cry Consolability (FLACC) Scale was developed by the Department of Anesthesiology, University of Michigan Medical School and Health Systems. The FLACC Scale is a behavioral scale for scoring postoperative pain in children between the ages of two months and seven years or in persons unable to communicate. In this trial the scale was used in the young and very young children, i.e. in participants aged 2 to less than 6 years. This tool includes five categories of pain behaviors, including facial expression, leg movement, activity, cry, and consolability. The clinician observes the participant for 5 minutes or more and scores each category with a 0, 1 or 2. The scores are added together for a total score ranging from 0 (no pain) to 10 (worst pain). The higher the total score the higher the pain.</description>
        <time_frame>Baseline; 15 hours post-dose</time_frame>
        <population>The protocol pre-specified that the young and very young children will be reported as one group.</population>
        <group_list>
          <group group_id="O1">
            <title>Face, Legs, Activity, Cry, Consolability Scale</title>
            <description>Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Intensity Assessment Using the Face, Legs, Activity, Cry, Consolability Scale in Young and Very Young Children (Age 2 to Less Than 6 Years).</title>
          <description>The Face Legs Activity Cry Consolability (FLACC) Scale was developed by the Department of Anesthesiology, University of Michigan Medical School and Health Systems. The FLACC Scale is a behavioral scale for scoring postoperative pain in children between the ages of two months and seven years or in persons unable to communicate. In this trial the scale was used in the young and very young children, i.e. in participants aged 2 to less than 6 years. This tool includes five categories of pain behaviors, including facial expression, leg movement, activity, cry, and consolability. The clinician observes the participant for 5 minutes or more and scores each category with a 0, 1 or 2. The scores are added together for a total score ranging from 0 (no pain) to 10 (worst pain). The higher the total score the higher the pain.</description>
          <population>The protocol pre-specified that the young and very young children will be reported as one group.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.2" spread="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 minutes post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.8" spread="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 minutes post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2" spread="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 hour post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1" spread="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 hours post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 hours post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5" spread="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 hours post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" spread="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>11 hours post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" spread="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 hours post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sum of Pain Intensity Differences Over the 4 Hours After Dosing Derived From the Different Pain Scales and for All Age Groups</title>
        <description>Different pain intensity assessment tools were used in the different age groups. Therefore the sum of pain intensities were calculated and are reported for each age group based on the tool used.&#xD;
Adolescents - Age 12 to Less Than 18 Years.&#xD;
Older Children - Age 6 to Less Than 12 Years.&#xD;
Young Children - Age 3 to Less Than 6 Years.&#xD;
Very Young Children - Age 2 to Less Than 3 Years.&#xD;
CAS (McGrath color analog scale) [Theoretical Range: -40 to + 40],&#xD;
VAS (100 mm Visual Analog Scale) [Theoretical Range: -400 to + 400],&#xD;
FPS-R (6-point Faces Pain Scale - Revised) [Theoretical Range: -40 to + 40],&#xD;
FLACC (Face, Legs, Activity, Cry, and Consolability score) [Theoretical Range: -40 to + 40].&#xD;
A mean score of zero indicates that there was no pain intensity change over the 4 hours.&#xD;
The positive values indicate that in the group as a whole the sum of all pain intensity values over the first 4 hours lead to a reduction in pain in the time period.</description>
        <time_frame>Baseline; 4 hours post-dose</time_frame>
        <population>Protocol pre-specified reporting groups.</population>
        <group_list>
          <group group_id="O1">
            <title>Sum of Pain Intensity Differences</title>
            <description>The sum of pain intensity difference over 4 hours (SPID4) were calculated as the weighted sum of the scheduled pain intensity difference collected up to 4 hours after tapentadol oral solution administration.&#xD;
The time elapsed (in hours) since the previous measurement is multiplied with the pain intensity difference (PID) at the respective time, and defines the weight in the calculation of the weighted sum of pain intensity differences.</description>
          </group>
        </group_list>
        <measure>
          <title>Sum of Pain Intensity Differences Over the 4 Hours After Dosing Derived From the Different Pain Scales and for All Age Groups</title>
          <description>Different pain intensity assessment tools were used in the different age groups. Therefore the sum of pain intensities were calculated and are reported for each age group based on the tool used.&#xD;
Adolescents - Age 12 to Less Than 18 Years.&#xD;
Older Children - Age 6 to Less Than 12 Years.&#xD;
Young Children - Age 3 to Less Than 6 Years.&#xD;
Very Young Children - Age 2 to Less Than 3 Years.&#xD;
CAS (McGrath color analog scale) [Theoretical Range: -40 to + 40],&#xD;
VAS (100 mm Visual Analog Scale) [Theoretical Range: -400 to + 400],&#xD;
FPS-R (6-point Faces Pain Scale - Revised) [Theoretical Range: -40 to + 40],&#xD;
FLACC (Face, Legs, Activity, Cry, and Consolability score) [Theoretical Range: -40 to + 40].&#xD;
A mean score of zero indicates that there was no pain intensity change over the 4 hours.&#xD;
The positive values indicate that in the group as a whole the sum of all pain intensity values over the first 4 hours lead to a reduction in pain in the time period.</description>
          <population>Protocol pre-specified reporting groups.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Adolescents SPID for VAS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="106.282" spread="75.350"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adolescents SPID for CAS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.925" spread="6.347"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Older Children SPID for CAS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.698" spread="7.610"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Older Children SPID for FPS-R</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.724" spread="6.868"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Young Children SPID for FPS-R</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.646" spread="14.674"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Young Children SPID for FLACC</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.614" spread="8.334"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Very Young Children SPID for FLACC</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.483" spread="8.955"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pharmacokinetic Profile of Serum Concentrations of Tapentadol-O-glucuronide After a Single Dose of Tapentadol Oral Solution in Adolescents (Age 12 to Less Than 18 Years).</title>
        <description>Mean and Standard Deviation of Serum Concentrations of Tapentadol-O-glucuronide. Tapentadol-O-glucuronide is the metabolite of tapentadol. Metabolites are sometimes referred to as &quot;breakdown products&quot;. The body alters the administered medication to a metabolite so that it can be more easily or quickly removed from the body. Tapentadol-O-glucuronide concentrations were measured in participants. Serum was analyzed by means of liquid chromatography coupled to tandem mass spectrometry with a lower limit of quantification (LLOQ) at 10 ng/mL.</description>
        <time_frame>up to 15 hours</time_frame>
        <population>Pharmacokinetic Set</population>
        <group_list>
          <group group_id="O1">
            <title>Tapentadol-O-glucuronide Serum Concentrations: Adolescents</title>
            <description>Tapentadol oral solution single dose (1mg/kg body weight). Participants aged 12 years and less than 18 years of age.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetic Profile of Serum Concentrations of Tapentadol-O-glucuronide After a Single Dose of Tapentadol Oral Solution in Adolescents (Age 12 to Less Than 18 Years).</title>
          <description>Mean and Standard Deviation of Serum Concentrations of Tapentadol-O-glucuronide. Tapentadol-O-glucuronide is the metabolite of tapentadol. Metabolites are sometimes referred to as &quot;breakdown products&quot;. The body alters the administered medication to a metabolite so that it can be more easily or quickly removed from the body. Tapentadol-O-glucuronide concentrations were measured in participants. Serum was analyzed by means of liquid chromatography coupled to tandem mass spectrometry with a lower limit of quantification (LLOQ) at 10 ng/mL.</description>
          <population>Pharmacokinetic Set</population>
          <units>nanogram per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>15 minutes post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="404" spread="581"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 minutes post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="855" spread="672"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 hour post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1424" spread="542"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 hours post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1202" spread="366"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 hours post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="824" spread="191"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 hours post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="497" spread="138"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>11 hours post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="150" spread="69.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 hours post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.9" spread="35.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pharmacokinetic Profile of Serum Concentrations of Tapentadol After a Single Dose of Tapentadol Oral Solution in Older Children (Age 6 to Less Than 12 Years).</title>
        <description>Mean and Standard Deviation of Serum Concentrations of Tapentadol. Serum was analyzed by means of liquid chromatography coupled to tandem mass spectrometry with a lower limit of quantification (LLOQ) at 0.2 ng/mL.</description>
        <time_frame>up to 15 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Tapentadol Serum Concentrations: Older Children</title>
            <description>Tapentadol oral solution single dose (1mg/kg body weight). Participants aged 6 years and less than 12 years of age.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetic Profile of Serum Concentrations of Tapentadol After a Single Dose of Tapentadol Oral Solution in Older Children (Age 6 to Less Than 12 Years).</title>
          <description>Mean and Standard Deviation of Serum Concentrations of Tapentadol. Serum was analyzed by means of liquid chromatography coupled to tandem mass spectrometry with a lower limit of quantification (LLOQ) at 0.2 ng/mL.</description>
          <units>nanogram per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>15 minutes to 1 hour post-dose (N=22)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.5" spread="21.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 to 4 hours post-dose (N=22)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.5" spread="15.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 to 11 hours post-dose (N=22)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.5" spread="6.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>11 to 15 hours post-dose (N=22)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.71" spread="1.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pharmacokinetic Profile of Serum Concentrations of Tapentadol-O-glucuronide After a Single Dose of Tapentadol Oral Solution in Older Children (Age 6 to Less Than 12 Years).</title>
        <description>Mean and Standard Deviation of Serum Concentrations of Tapentadol-O-glucuronide. Tapentadol-O-glucuronide is the metabolite of tapentadol. Metabolites are sometimes referred to as &quot;breakdown products&quot;. The body alters the administered medication to a metabolite so that it can be more easily or quickly removed from the body. Tapentadol-O-glucuronide concentrations were measured in participants. Serum was analyzed by means of liquid chromatography coupled to tandem mass spectrometry with a lower limit of quantification (LLOQ) at 10 ng/mL.</description>
        <time_frame>up to 15 hours</time_frame>
        <population>Pharmacokinetic Set</population>
        <group_list>
          <group group_id="O1">
            <title>Tapentadol-O-glucuronide Serum Concentrations: Older Children</title>
            <description>Tapentadol oral solution single dose (1mg/kg body weight). Participants aged 6 years and less than 12 years of age.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetic Profile of Serum Concentrations of Tapentadol-O-glucuronide After a Single Dose of Tapentadol Oral Solution in Older Children (Age 6 to Less Than 12 Years).</title>
          <description>Mean and Standard Deviation of Serum Concentrations of Tapentadol-O-glucuronide. Tapentadol-O-glucuronide is the metabolite of tapentadol. Metabolites are sometimes referred to as &quot;breakdown products&quot;. The body alters the administered medication to a metabolite so that it can be more easily or quickly removed from the body. Tapentadol-O-glucuronide concentrations were measured in participants. Serum was analyzed by means of liquid chromatography coupled to tandem mass spectrometry with a lower limit of quantification (LLOQ) at 10 ng/mL.</description>
          <population>Pharmacokinetic Set</population>
          <units>nanogram per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>15 minutes to 1 hour post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="676" spread="343"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 to 4 hours post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="900" spread="330"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 to 11 hours post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="321" spread="123"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>11 to 15 hours post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86.3" spread="37.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pharmacokinetic Profile of Serum Concentrations of Tapentadol After a Single Dose of Tapentadol Oral Solution in Younger Children (Age 3 to Less Than 6 Years).</title>
        <description>Mean and Standard Deviation of Serum Concentrations of Tapentadol. Serum was analyzed by means of liquid chromatography coupled to tandem mass spectrometry with a lower limit of quantification (LLOQ) at 0.2 ng/mL.</description>
        <time_frame>up to 15 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Tapentadol Serum Concentrations: Younger Children</title>
            <description>Tapentadol oral solution single dose (1mg/kg body weight). Participants aged 3 years and less than 6 years of age.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetic Profile of Serum Concentrations of Tapentadol After a Single Dose of Tapentadol Oral Solution in Younger Children (Age 3 to Less Than 6 Years).</title>
          <description>Mean and Standard Deviation of Serum Concentrations of Tapentadol. Serum was analyzed by means of liquid chromatography coupled to tandem mass spectrometry with a lower limit of quantification (LLOQ) at 0.2 ng/mL.</description>
          <units>nanogram per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>15 minutes to 1 hour post-dose (N = 11)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.1" spread="19.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 to 11 hours post-dose (N=11)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.4" spread="10.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pharmacokinetic Profile of Serum Concentrations of Tapentadol-O-glucuronide After a Single Dose of Tapentadol Oral Solution in Younger Children (Age 3 to Less Than 6 Years).</title>
        <description>Mean and Standard Deviation of Serum Concentrations of Tapentadol-O-glucuronide. Tapentadol-O-glucuronide is the metabolite of tapentadol. Metabolites are sometimes referred to as &quot;breakdown products&quot;. The body alters the administered medication to a metabolite so that it can be more easily or quickly removed from the body. Tapentadol-O-glucuronide concentrations were measured in participants. Serum was analyzed by means of liquid chromatography coupled to tandem mass spectrometry with a lower limit of quantification (LLOQ) at 10 ng/mL.</description>
        <time_frame>up to 15 hours</time_frame>
        <population>Pharmacokinetic Set</population>
        <group_list>
          <group group_id="O1">
            <title>Tapentadol-O-glucuronide Serum Concentrations Younger Children</title>
            <description>Tapentadol oral solution single dose (1mg/kg body weight). Participants aged 3 years and less than 6 years of age.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetic Profile of Serum Concentrations of Tapentadol-O-glucuronide After a Single Dose of Tapentadol Oral Solution in Younger Children (Age 3 to Less Than 6 Years).</title>
          <description>Mean and Standard Deviation of Serum Concentrations of Tapentadol-O-glucuronide. Tapentadol-O-glucuronide is the metabolite of tapentadol. Metabolites are sometimes referred to as &quot;breakdown products&quot;. The body alters the administered medication to a metabolite so that it can be more easily or quickly removed from the body. Tapentadol-O-glucuronide concentrations were measured in participants. Serum was analyzed by means of liquid chromatography coupled to tandem mass spectrometry with a lower limit of quantification (LLOQ) at 10 ng/mL.</description>
          <population>Pharmacokinetic Set</population>
          <units>nanogram per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>15 minutes to 1 hour post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="494" spread="377"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 to 11 hours post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="504" spread="112"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pharmacokinetic Profile of Serum Concentrations of Tapentadol After a Single Dose of Tapentadol Oral Solution in Very Young Children (Age 2 to Less Than 3 Years).</title>
        <description>Mean and Standard Deviation of Serum Concentrations of Tapentadol. Serum was analyzed by means of liquid chromatography coupled to tandem mass spectrometry with a lower limit of quantification (LLOQ) at 0.2 ng/mL.</description>
        <time_frame>up to 15 hours</time_frame>
        <population>Pharmacokinetic Set</population>
        <group_list>
          <group group_id="O1">
            <title>Tapentadol Serum Concentrations: Very Young Children</title>
            <description>Tapentadol oral solution single dose (1mg/kg body weight). Participants aged 2 years and less than 3 years of age.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetic Profile of Serum Concentrations of Tapentadol After a Single Dose of Tapentadol Oral Solution in Very Young Children (Age 2 to Less Than 3 Years).</title>
          <description>Mean and Standard Deviation of Serum Concentrations of Tapentadol. Serum was analyzed by means of liquid chromatography coupled to tandem mass spectrometry with a lower limit of quantification (LLOQ) at 0.2 ng/mL.</description>
          <population>Pharmacokinetic Set</population>
          <units>nanogram per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>1.25 hours post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.9" spread="13.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 hours post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.7" spread="18.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5 hours post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.4" spread="6.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8 hours post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.0" spread="4.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pharmacokinetic Profile of Serum Concentrations of Tapentadol-O-glucuronide After a Single Dose of Tapentadol Oral Solution in Very Young Children (Age 2 to Less Than 3 Years).</title>
        <description>Mean and Standard Deviation of Serum Concentrations of Tapentadol-O-glucuronide. Tapentadol-O-glucuronide is the metabolite of tapentadol. Metabolites are sometimes referred to as &quot;breakdown products&quot;. The body alters the administered medication to a metabolite so that it can be more easily or quickly removed from the body. Tapentadol-O-glucuronide concentrations were measured in participants. Serum was analyzed by means of liquid chromatography coupled to tandem mass spectrometry with a lower limit of quantification (LLOQ) at 10 ng/mL.</description>
        <time_frame>up to 15 hours</time_frame>
        <population>Pharmacokinetic Set</population>
        <group_list>
          <group group_id="O1">
            <title>Tapentadol-O-glucuronide Concentrations: Very Young Children</title>
            <description>Tapentadol oral solution single dose (1mg/kg body weight). Participants aged 2 years and less than 3 years of age.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetic Profile of Serum Concentrations of Tapentadol-O-glucuronide After a Single Dose of Tapentadol Oral Solution in Very Young Children (Age 2 to Less Than 3 Years).</title>
          <description>Mean and Standard Deviation of Serum Concentrations of Tapentadol-O-glucuronide. Tapentadol-O-glucuronide is the metabolite of tapentadol. Metabolites are sometimes referred to as &quot;breakdown products&quot;. The body alters the administered medication to a metabolite so that it can be more easily or quickly removed from the body. Tapentadol-O-glucuronide concentrations were measured in participants. Serum was analyzed by means of liquid chromatography coupled to tandem mass spectrometry with a lower limit of quantification (LLOQ) at 10 ng/mL.</description>
          <population>Pharmacokinetic Set</population>
          <units>nanogram per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>1.25 hours after administration</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="497" spread="513"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 hours after administration</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="938" spread="407"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5 hours after administration</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="624" spread="235"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8 hours after administration</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="253" spread="103"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Non-Compartmental Pharmacokinetic (PK) Parameter of Tapentadol Area Under the Concentration-Time Curve (AUC 0-15) After a Single Dose of Tapentadol in Adolescent Participants (Age 12 to Less Than 18 Years).</title>
        <description>Serum samples for pharmacokinetic analysis were obtained using frequent sampling techniques in participants 12 years to less than 18 years of age.&#xD;
Serum samples (frequent sampling) were drawn at 0.25, 0.5, 1, 2, 4, 6, 11, and 15 hours.&#xD;
The Area Under the Curve (AUC) from dose to 15 hours (AUC 0-15) is a summary measure of data from each pharmacokinetic blood sample taken over the 15 hour time period.&#xD;
The area is that below the line fitted to the data points.</description>
        <time_frame>up to 15 hours</time_frame>
        <population>The protocol planned that this analysis would only be performed for the adolescent participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Tapentadol Non-Compartmental PK Parameter: AUC</title>
            <description>Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
        </group_list>
        <measure>
          <title>Non-Compartmental Pharmacokinetic (PK) Parameter of Tapentadol Area Under the Concentration-Time Curve (AUC 0-15) After a Single Dose of Tapentadol in Adolescent Participants (Age 12 to Less Than 18 Years).</title>
          <description>Serum samples for pharmacokinetic analysis were obtained using frequent sampling techniques in participants 12 years to less than 18 years of age.&#xD;
Serum samples (frequent sampling) were drawn at 0.25, 0.5, 1, 2, 4, 6, 11, and 15 hours.&#xD;
The Area Under the Curve (AUC) from dose to 15 hours (AUC 0-15) is a summary measure of data from each pharmacokinetic blood sample taken over the 15 hour time period.&#xD;
The area is that below the line fitted to the data points.</description>
          <population>The protocol planned that this analysis would only be performed for the adolescent participants.</population>
          <units>ng*hr/mL</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="302" lower_limit="218" upper_limit="636"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Respiratory Rate Assessments</title>
        <description>Respiratory rate assessments were performed at pre-defined times during the 15 hour period following investigational medicinal product intake.&#xD;
Pre-surgery data for these participants is also given from the enrollment Visit (Visit 1).</description>
        <time_frame>Enrollment Visit; 15 hours post-dose</time_frame>
        <population>The protocol pre-specified that the young and very young children will be reported as one group.&#xD;
(Adolescents Group at and after 2 hours: N=20; Older Children Group at 30 minutes and 1 hour N=27, at 2 hours N=24, and at and after 4 hours N=22; Young and Very Young Children Group at and after 4 hours: N=16).</population>
        <group_list>
          <group group_id="O1">
            <title>Respiratory Rates: Adolescents</title>
            <description>Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
          <group group_id="O2">
            <title>Respiratory Rates: Older Children</title>
            <description>Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
          <group group_id="O3">
            <title>Respiratory Rates: Young and Very Young Children</title>
            <description>Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
        </group_list>
        <measure>
          <title>Respiratory Rate Assessments</title>
          <description>Respiratory rate assessments were performed at pre-defined times during the 15 hour period following investigational medicinal product intake.&#xD;
Pre-surgery data for these participants is also given from the enrollment Visit (Visit 1).</description>
          <population>The protocol pre-specified that the young and very young children will be reported as one group.&#xD;
(Adolescents Group at and after 2 hours: N=20; Older Children Group at 30 minutes and 1 hour N=27, at 2 hours N=24, and at and after 4 hours N=22; Young and Very Young Children Group at and after 4 hours: N=16).</population>
          <units>breaths per minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.8" spread="3.2"/>
                    <measurement group_id="O2" value="18.4" spread="3.1"/>
                    <measurement group_id="O3" value="25.1" spread="3.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pre-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.4" spread="2.5"/>
                    <measurement group_id="O2" value="19.2" spread="2.5"/>
                    <measurement group_id="O3" value="25.1" spread="3.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 minutes post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.8" spread="2.6"/>
                    <measurement group_id="O2" value="19.7" spread="2.5"/>
                    <measurement group_id="O3" value="24.0" spread="3.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 minutes post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.5" spread="2.5"/>
                    <measurement group_id="O2" value="19.4" spread="2.4"/>
                    <measurement group_id="O3" value="22.6" spread="4.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 hours post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.9" spread="2.3"/>
                    <measurement group_id="O2" value="19.0" spread="2.0"/>
                    <measurement group_id="O3" value="21.8" spread="3.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 hours post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.3" spread="2.8"/>
                    <measurement group_id="O2" value="19.3" spread="2.5"/>
                    <measurement group_id="O3" value="22.5" spread="3.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 hours post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.4" spread="2.1"/>
                    <measurement group_id="O2" value="19.5" spread="2.8"/>
                    <measurement group_id="O3" value="22.5" spread="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 hours post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.9" spread="2.9"/>
                    <measurement group_id="O2" value="19.0" spread="3.8"/>
                    <measurement group_id="O3" value="22.1" spread="3.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>11 hours post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.4" spread="3.6"/>
                    <measurement group_id="O2" value="18.4" spread="2.9"/>
                    <measurement group_id="O3" value="22.4" spread="3.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 hours post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.1" spread="2.5"/>
                    <measurement group_id="O2" value="17.3" spread="3.0"/>
                    <measurement group_id="O3" value="21.1" spread="3.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Oxygen Saturation Assessments</title>
        <description>Oxygen saturation assessments were performed at pre-defined times during the 15 hour period following investigational medicinal product intake.&#xD;
Oxygen saturation was assessed using pulse oximetry. The uppermost value is 100%.&#xD;
Pre-surgery data for these participants is also given from the enrollment Visit (Visit 1).</description>
        <time_frame>Enrollment Visit; 15 hours post-dose</time_frame>
        <population>The protocol pre-specified that the young and very young children will be reported as one group.&#xD;
(Adolescents Group at and after 2 hours: N=20; Older Children Group at 30 minutes and 1 hour N=27, at 2 hours N=24, at and after 4 hours N=22; Young and Very Young Children Group at and after 4 hours: N=16).</population>
        <group_list>
          <group group_id="O1">
            <title>Oxygen Saturation: Adolescents</title>
            <description>Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
          <group group_id="O2">
            <title>Oxygen Saturation: Older Children</title>
            <description>Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
          <group group_id="O3">
            <title>Oxygen Saturation: Young and Very Young Children</title>
            <description>Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
        </group_list>
        <measure>
          <title>Oxygen Saturation Assessments</title>
          <description>Oxygen saturation assessments were performed at pre-defined times during the 15 hour period following investigational medicinal product intake.&#xD;
Oxygen saturation was assessed using pulse oximetry. The uppermost value is 100%.&#xD;
Pre-surgery data for these participants is also given from the enrollment Visit (Visit 1).</description>
          <population>The protocol pre-specified that the young and very young children will be reported as one group.&#xD;
(Adolescents Group at and after 2 hours: N=20; Older Children Group at 30 minutes and 1 hour N=27, at 2 hours N=24, at and after 4 hours N=22; Young and Very Young Children Group at and after 4 hours: N=16).</population>
          <units>percentage of oxygen saturation</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.8" spread="1.1"/>
                    <measurement group_id="O2" value="97.4" spread="1.7"/>
                    <measurement group_id="O3" value="97.4" spread="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pre-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.7" spread="1.4"/>
                    <measurement group_id="O2" value="96.7" spread="1.4"/>
                    <measurement group_id="O3" value="96.8" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 minutes post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.3" spread="1.2"/>
                    <measurement group_id="O2" value="96.8" spread="1.3"/>
                    <measurement group_id="O3" value="96.5" spread="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 minutes post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.0" spread="1.4"/>
                    <measurement group_id="O2" value="96.4" spread="1.3"/>
                    <measurement group_id="O3" value="96.8" spread="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 hour post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.3" spread="1.2"/>
                    <measurement group_id="O2" value="96.0" spread="1.6"/>
                    <measurement group_id="O3" value="96.2" spread="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 hours post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.1" spread="1.3"/>
                    <measurement group_id="O2" value="95.8" spread="1.4"/>
                    <measurement group_id="O3" value="95.8" spread="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 hours post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.9" spread="1.4"/>
                    <measurement group_id="O2" value="96.5" spread="1.2"/>
                    <measurement group_id="O3" value="96.5" spread="1.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 hours post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.1" spread="1.5"/>
                    <measurement group_id="O2" value="96.7" spread="1.3"/>
                    <measurement group_id="O3" value="96.7" spread="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>11 hours post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.8" spread="1.4"/>
                    <measurement group_id="O2" value="96.8" spread="1.4"/>
                    <measurement group_id="O3" value="96.4" spread="1.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 hours post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.7" spread="1.0"/>
                    <measurement group_id="O2" value="96.5" spread="1.4"/>
                    <measurement group_id="O3" value="97.1" spread="1.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Systolic and Diastolic Blood Pressure Assessments</title>
        <description>Systolic and Diastolic blood pressure assessments were performed at pre-defined times during the 15 hour period following investigational medicinal product intake.&#xD;
Pre-surgery data for these participants is also given from the enrollment Visit (Visit 1).</description>
        <time_frame>Enrollment Visit; 15 hours post-dose</time_frame>
        <population>The protocol pre-specified that the young and very young children will be reported as one group.&#xD;
(Adolescents Group at and after 2 hours: N=20; Older Children Group at 30 minutes and 1 hour N=27, at 2 hours N=24, at and after 4 hours N=22; Young and Very Young Children Group at and after 4 hours: N=16).</population>
        <group_list>
          <group group_id="O1">
            <title>Blood Pressure: Adolescents</title>
            <description>Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
          <group group_id="O2">
            <title>Blood Pressure: Older Children</title>
            <description>Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
          <group group_id="O3">
            <title>Blood Pressure: Young and Very Young Children</title>
            <description>Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
        </group_list>
        <measure>
          <title>Systolic and Diastolic Blood Pressure Assessments</title>
          <description>Systolic and Diastolic blood pressure assessments were performed at pre-defined times during the 15 hour period following investigational medicinal product intake.&#xD;
Pre-surgery data for these participants is also given from the enrollment Visit (Visit 1).</description>
          <population>The protocol pre-specified that the young and very young children will be reported as one group.&#xD;
(Adolescents Group at and after 2 hours: N=20; Older Children Group at 30 minutes and 1 hour N=27, at 2 hours N=24, at and after 4 hours N=22; Young and Very Young Children Group at and after 4 hours: N=16).</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 1 Enrollment Systolic blood pressure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="110.2" spread="9.0"/>
                    <measurement group_id="O2" value="103.8" spread="9.6"/>
                    <measurement group_id="O3" value="98.7" spread="7.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pre-dose Systolic Blood Pressure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="122.9" spread="13.9"/>
                    <measurement group_id="O2" value="107.1" spread="9.1"/>
                    <measurement group_id="O3" value="105.1" spread="15.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 minutes post-dose Systolic Blood Pressure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="126.9" spread="17.7"/>
                    <measurement group_id="O2" value="104.1" spread="8.3"/>
                    <measurement group_id="O3" value="101.8" spread="7.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 minutes post-dose Systolic Blood Pressure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="126.8" spread="17.9"/>
                    <measurement group_id="O2" value="104.1" spread="7.2"/>
                    <measurement group_id="O3" value="100.1" spread="6.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 hour post-dose Systolic Blood Pressure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="127.0" spread="17.7"/>
                    <measurement group_id="O2" value="104.0" spread="9.6"/>
                    <measurement group_id="O3" value="97.6" spread="7.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 hours post-dose Systolic Blood Pressure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="124.9" spread="16.7"/>
                    <measurement group_id="O2" value="103.9" spread="8.2"/>
                    <measurement group_id="O3" value="98.4" spread="6.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 hours post-dose Systolic Blood Pressure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="122.8" spread="13.9"/>
                    <measurement group_id="O2" value="104.8" spread="10.5"/>
                    <measurement group_id="O3" value="100.1" spread="7.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 hours post-dose Systolic Blood Pressure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="116.8" spread="14.1"/>
                    <measurement group_id="O2" value="106.7" spread="7.9"/>
                    <measurement group_id="O3" value="102.0" spread="8.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>11 hours post-dose Systolic Blood Pressure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="115.1" spread="11.2"/>
                    <measurement group_id="O2" value="102.0" spread="9.1"/>
                    <measurement group_id="O3" value="99.4" spread="14.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 hours post-dose Systolic Blood Pressure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="113.8" spread="14.2"/>
                    <measurement group_id="O2" value="100.3" spread="8.7"/>
                    <measurement group_id="O3" value="93.3" spread="9.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 1 Enrollment Diastolic blood pressure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.5" spread="9.0"/>
                    <measurement group_id="O2" value="66.3" spread="8.3"/>
                    <measurement group_id="O3" value="62.8" spread="5.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pre-dose Diastolic blood pressure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74.8" spread="11.8"/>
                    <measurement group_id="O2" value="64.2" spread="9.4"/>
                    <measurement group_id="O3" value="65.6" spread="11.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 minutes post-dose Diastolic blood pressure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78.9" spread="15.7"/>
                    <measurement group_id="O2" value="62.4" spread="7.8"/>
                    <measurement group_id="O3" value="62.4" spread="7.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 minutes post-dose Diastolic blood pressure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76.1" spread="12.0"/>
                    <measurement group_id="O2" value="61.3" spread="5.7"/>
                    <measurement group_id="O3" value="60.2" spread="6.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 hour post-dose Diastolic blood pressure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77.6" spread="13.0"/>
                    <measurement group_id="O2" value="61.1" spread="7.1"/>
                    <measurement group_id="O3" value="59.6" spread="6.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 hours post-dose Diastolic blood pressure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74.7" spread="13.4"/>
                    <measurement group_id="O2" value="59.7" spread="7.0"/>
                    <measurement group_id="O3" value="59.7" spread="7.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 hours post-dose Diastolic blood pressure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.2" spread="12.1"/>
                    <measurement group_id="O2" value="60.0" spread="7.1"/>
                    <measurement group_id="O3" value="58.7" spread="5.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 hours post-dose Diastolic blood pressure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.0" spread="10.3"/>
                    <measurement group_id="O2" value="59.0" spread="8.3"/>
                    <measurement group_id="O3" value="58.8" spread="7.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>11 hours post-dose Diastolic blood pressure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.4" spread="8.4"/>
                    <measurement group_id="O2" value="54.6" spread="8.5"/>
                    <measurement group_id="O3" value="57.3" spread="11.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 hours post-dose Diastolic blood pressure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67.1" spread="10.8"/>
                    <measurement group_id="O2" value="56.8" spread="8.5"/>
                    <measurement group_id="O3" value="57.0" spread="8.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Enrollment in 12-lead Electrocardiogram Parameters</title>
        <description>12-lead electrocardiograms (ECG) were part of the planned safety assessments. 12-lead Electrocardiograms were performed prior at the enrollment visit after informed consent and at the discharge visit. The discharge visit was as per standard of care.&#xD;
The changes in ECG parameters are reported. Negative mean values indicate that the millisecond intervals decreased from the enrollment to the discharge visit. Positive mean values indicate that the millisecond intervals increased from the enrollment to the discharge visit. The Letters P,Q,R,S and T refer to specific medically defined points on an ECG tracing and correspond to specific heart activities.</description>
        <time_frame>Enrollment (pre-surgery); Discharge Visit</time_frame>
        <population>The protocol pre-specified that the young and very young children will be reported as one group.&#xD;
(For older children N=27 at Visit 1)</population>
        <group_list>
          <group group_id="O1">
            <title>ECG Changes: Adolescents</title>
            <description>Single Dose of Tapentadol Oral Solution in Children and Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
          <group group_id="O2">
            <title>ECG Changes: Older Children</title>
            <description>Single Dose of Tapentadol Oral Solution in Children and Adolescents Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
          <group group_id="O3">
            <title>ECG Changes: Young and Very Young Children</title>
            <description>Single Dose of Tapentadol Oral Solution in Children and Adolescents Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Enrollment in 12-lead Electrocardiogram Parameters</title>
          <description>12-lead electrocardiograms (ECG) were part of the planned safety assessments. 12-lead Electrocardiograms were performed prior at the enrollment visit after informed consent and at the discharge visit. The discharge visit was as per standard of care.&#xD;
The changes in ECG parameters are reported. Negative mean values indicate that the millisecond intervals decreased from the enrollment to the discharge visit. Positive mean values indicate that the millisecond intervals increased from the enrollment to the discharge visit. The Letters P,Q,R,S and T refer to specific medically defined points on an ECG tracing and correspond to specific heart activities.</description>
          <population>The protocol pre-specified that the young and very young children will be reported as one group.&#xD;
(For older children N=27 at Visit 1)</population>
          <units>milliseconds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="27"/>
                <count group_id="O3" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>QTcF change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.6" spread="16.4"/>
                    <measurement group_id="O2" value="15.7" spread="21.7"/>
                    <measurement group_id="O3" value="5.6" spread="20.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QT Duration change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.0" spread="33.1"/>
                    <measurement group_id="O2" value="8.5" spread="32.0"/>
                    <measurement group_id="O3" value="-4.1" spread="29.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QRS Duration change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5" spread="4.5"/>
                    <measurement group_id="O2" value="-0.2" spread="4.7"/>
                    <measurement group_id="O3" value="0.5" spread="5.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PR Duration change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.5" spread="11.7"/>
                    <measurement group_id="O2" value="-1.8" spread="11.3"/>
                    <measurement group_id="O3" value="-2.4" spread="12.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RR Duration change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-32.2" spread="193.8"/>
                    <measurement group_id="O2" value="-35.2" spread="156.5"/>
                    <measurement group_id="O3" value="-48.1" spread="102.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Enrollment in 12-lead Electrocardiogram Heart Rate Parameter</title>
        <description>12-lead Electrocardiograms (ECG) were part of the planned safety assessments. 12-lead Electrocardiograms were performed prior at the enrollment visit after informed consent and at the discharge visit. The discharge visit was as per standard of care.&#xD;
The changes in heart rate (beats per minute) parameters are reported per treatment group between the visits.&#xD;
A positive value indicates that the heart rate was higher at discharge than at enrollment.</description>
        <time_frame>Enrollment; Discharge Visit</time_frame>
        <population>The protocol pre-specified that the young and very young children will be reported as one group.&#xD;
(For older children: N=27 at Visit 1)</population>
        <group_list>
          <group group_id="O1">
            <title>ECG Heart Rate Change: Adolescents</title>
            <description>Single Dose of Tapentadol Oral Solution in Children and Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
          <group group_id="O2">
            <title>ECG Heart Rate Change: Older Children</title>
            <description>Single Dose of Tapentadol Oral Solution in Children and Adolescents Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
          <group group_id="O3">
            <title>ECG Heart Rate Change: Young and Very Young Children</title>
            <description>Single Dose of Tapentadol Oral Solution in Children and Adolescents Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Enrollment in 12-lead Electrocardiogram Heart Rate Parameter</title>
          <description>12-lead Electrocardiograms (ECG) were part of the planned safety assessments. 12-lead Electrocardiograms were performed prior at the enrollment visit after informed consent and at the discharge visit. The discharge visit was as per standard of care.&#xD;
The changes in heart rate (beats per minute) parameters are reported per treatment group between the visits.&#xD;
A positive value indicates that the heart rate was higher at discharge than at enrollment.</description>
          <population>The protocol pre-specified that the young and very young children will be reported as one group.&#xD;
(For older children: N=27 at Visit 1)</population>
          <units>beats per minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" spread="16.4"/>
                    <measurement group_id="O2" value="4.3" spread="16.2"/>
                    <measurement group_id="O3" value="10.7" spread="16.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Non-Compartmental Pharmacokinetic (PK) Parameter: Cmax (Maximum Concentration) of Tapentadol After a Single Dose of Tapentadol in Adolescents (Age 12 to Less Than 18 Years).</title>
        <description>Serum samples for pharmacokinetic analysis were obtained using frequent sampling techniques in participants 12 years to less than 18 years of age.&#xD;
Serum samples (frequent sampling) were drawn at 0.25, 0.5, 1, 2, 4, 6, 11, and 15 hours. The concentration of tapentadol (active drug) is assessed during absorption and distribution.&#xD;
The maximum concentration is derived from the Area Under the Curve, from dose to 15 hours (AUC 0-15). It is the highest amount of active drug observed in the blood sample</description>
        <time_frame>up to 15 hours</time_frame>
        <population>The protocol planned that this analysis would only be performed for the adolescent participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Tapentadol Non-Compartmental PK Parameter: Cmax</title>
            <description>Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
        </group_list>
        <measure>
          <title>Non-Compartmental Pharmacokinetic (PK) Parameter: Cmax (Maximum Concentration) of Tapentadol After a Single Dose of Tapentadol in Adolescents (Age 12 to Less Than 18 Years).</title>
          <description>Serum samples for pharmacokinetic analysis were obtained using frequent sampling techniques in participants 12 years to less than 18 years of age.&#xD;
Serum samples (frequent sampling) were drawn at 0.25, 0.5, 1, 2, 4, 6, 11, and 15 hours. The concentration of tapentadol (active drug) is assessed during absorption and distribution.&#xD;
The maximum concentration is derived from the Area Under the Curve, from dose to 15 hours (AUC 0-15). It is the highest amount of active drug observed in the blood sample</description>
          <population>The protocol planned that this analysis would only be performed for the adolescent participants.</population>
          <units>nanograms/millilitre</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67.5" spread="26.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Treatment Emergent Adverse Events by Intensity</title>
        <description>The intensity of all treatment emergent adverse events (TEAEs) were scored by the investigator. Treatment emergent adverse events were those adverse events documented from the time of investigational medicinal product (IMP), study drug, up to 48 hours post dosing.&#xD;
The clinical &quot;intensity&quot; of an adverse event was classified as:&#xD;
Mild: Signs and symptoms that can be easily tolerated. Symptoms can be ignored and disappear when the subject is distracted.&#xD;
Moderate: Symptoms cause discomfort but are tolerable; they cannot be ignored and affect concentration.&#xD;
Severe: Symptoms which affect usual daily activity.&#xD;
For adverse events where the intensity changes over time, the maximum intensity observed was documented.</description>
        <time_frame>Baseline; 48 hours post dosing</time_frame>
        <population>The protocol pre-specified that the young and very young children will be reported as one group.</population>
        <group_list>
          <group group_id="O1">
            <title>Number of TEAEs: Adolescents</title>
            <description>Tapentadol oral solution single dose (1mg/kg body weight). Participants aged 12 years and less than 18 years of age.</description>
          </group>
          <group group_id="O2">
            <title>Number of TEAEs: Older Children</title>
            <description>Tapentadol oral solution single dose (1mg/kg body weight). Participants aged 6 years and less than 12 years of age.</description>
          </group>
          <group group_id="O3">
            <title>Number of TEAEs: Young and Very Young Children</title>
            <description>Tapentadol oral solution single dose (1mg/kg body weight). Participants aged 2 years and less than 6 years of age.</description>
          </group>
        </group_list>
        <measure>
          <title>Treatment Emergent Adverse Events by Intensity</title>
          <description>The intensity of all treatment emergent adverse events (TEAEs) were scored by the investigator. Treatment emergent adverse events were those adverse events documented from the time of investigational medicinal product (IMP), study drug, up to 48 hours post dosing.&#xD;
The clinical &quot;intensity&quot; of an adverse event was classified as:&#xD;
Mild: Signs and symptoms that can be easily tolerated. Symptoms can be ignored and disappear when the subject is distracted.&#xD;
Moderate: Symptoms cause discomfort but are tolerable; they cannot be ignored and affect concentration.&#xD;
Severe: Symptoms which affect usual daily activity.&#xD;
For adverse events where the intensity changes over time, the maximum intensity observed was documented.</description>
          <population>The protocol pre-specified that the young and very young children will be reported as one group.</population>
          <units>number of events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Total number of TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="33"/>
                    <measurement group_id="O3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total number of mild TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="16"/>
                    <measurement group_id="O3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total number of moderate TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="17"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Intake of Additional Analgesic Medication During the Trial</title>
        <description>Number of participants with intakes of supplemental analgesic medication between investigational medicinal product (IMP) intake and Site Discharge grouped according to preparation taken (non-opioid/opioid).</description>
        <time_frame>Baseline; 15 hours post dosing</time_frame>
        <population>The protocol pre-specified that the young and very young children will be reported as one group.</population>
        <group_list>
          <group group_id="O1">
            <title>Adolescents With Supplementary Analgesic</title>
            <description>Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
          <group group_id="O2">
            <title>Older Children With Supplementary Analgesic</title>
            <description>Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
          <group group_id="O3">
            <title>Young and Very Young Children With Supplementary Analgesic</title>
            <description>Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
        </group_list>
        <measure>
          <title>Intake of Additional Analgesic Medication During the Trial</title>
          <description>Number of participants with intakes of supplemental analgesic medication between investigational medicinal product (IMP) intake and Site Discharge grouped according to preparation taken (non-opioid/opioid).</description>
          <population>The protocol pre-specified that the young and very young children will be reported as one group.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Supplemental analgesic medication taken</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="18"/>
                    <measurement group_id="O3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Supplemental opioid analgesic taken</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Supplemental non-opioid analgesic taken</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="18"/>
                    <measurement group_id="O3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Non-Compartmental Pharmacokinetic (PK) Parameter: Time to Maximum Concentration (Tmax) of Tapentadol After a Single Dose of Tapentadol in Adolescents (Age 12 to Less Than 18 Years).</title>
        <description>Serum samples for pharmacokinetic analysis were obtained using frequent sampling techniques in participants 12 years to less than 18 years of age.&#xD;
The time to maximum concentration is derived from the area under the curve from dose to 15 hours (AUC 0-15). The Tmax is the time after dosing at which the maximum concentration of the tapentadol (active drug) occurs.&#xD;
Serum samples (frequent sampling) were drawn at 0.25, 0.5, 1, 2, 4, 6, 11, and 15 hours.</description>
        <time_frame>up to 15 hours</time_frame>
        <population>The protocol planned that this analysis would only be performed for the adolescent participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Tapentadol Non-Compartmental PK Parameter: Tmax</title>
            <description>Tapentadol oral solution single dose (1mg/kg body weight) of participants aged 12 years to less than 18 years old.</description>
          </group>
        </group_list>
        <measure>
          <title>Non-Compartmental Pharmacokinetic (PK) Parameter: Time to Maximum Concentration (Tmax) of Tapentadol After a Single Dose of Tapentadol in Adolescents (Age 12 to Less Than 18 Years).</title>
          <description>Serum samples for pharmacokinetic analysis were obtained using frequent sampling techniques in participants 12 years to less than 18 years of age.&#xD;
The time to maximum concentration is derived from the area under the curve from dose to 15 hours (AUC 0-15). The Tmax is the time after dosing at which the maximum concentration of the tapentadol (active drug) occurs.&#xD;
Serum samples (frequent sampling) were drawn at 0.25, 0.5, 1, 2, 4, 6, 11, and 15 hours.</description>
          <population>The protocol planned that this analysis would only be performed for the adolescent participants.</population>
          <units>hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4" spread="1.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Non-Compartmental Pharmacokinetic (PK) Parameter of Tapentadol-O-glucuronide Area Under the Concentration-Time Curve (AUC 0-15) After a Single Dose of Tapentadol in Adolescents (Age 12 to Less Than 18 Years).</title>
        <description>Serum samples for pharmacokinetic analysis were obtained using frequent sampling techniques in participants 12 years to less than 18 years of age.&#xD;
Serum samples (frequent sampling) were drawn at 0.25, 0.5, 1, 2, 4, 6, 11, and 15 hours. The concentration of tapentadol (active drug) is assessed during absorption and distribution.&#xD;
The maximum concentration is derived from the Area Under the Curve, from dose to 15 hours (AUC 0-15). It is the highest amount of active drug observed in the blood sample.</description>
        <time_frame>up to 15 hours</time_frame>
        <population>The protocol planned that this analysis would only be performed for the adolescent participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Tapentadol-O-glucuronide Non-Compartmental PK Parameter: AUC</title>
            <description>Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
        </group_list>
        <measure>
          <title>Non-Compartmental Pharmacokinetic (PK) Parameter of Tapentadol-O-glucuronide Area Under the Concentration-Time Curve (AUC 0-15) After a Single Dose of Tapentadol in Adolescents (Age 12 to Less Than 18 Years).</title>
          <description>Serum samples for pharmacokinetic analysis were obtained using frequent sampling techniques in participants 12 years to less than 18 years of age.&#xD;
Serum samples (frequent sampling) were drawn at 0.25, 0.5, 1, 2, 4, 6, 11, and 15 hours. The concentration of tapentadol (active drug) is assessed during absorption and distribution.&#xD;
The maximum concentration is derived from the Area Under the Curve, from dose to 15 hours (AUC 0-15). It is the highest amount of active drug observed in the blood sample.</description>
          <population>The protocol planned that this analysis would only be performed for the adolescent participants.</population>
          <units>ng*hr/mL</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7082" lower_limit="4946" upper_limit="9689"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Non-Compartmental Pharmacokinetic (PK) Parameter: Cmax (Maximum Concentration) of Tapentadol-O-glucuronide After a Single Dose of Tapentadol in Adolescents (Age 12 to Less Than 18 Years).</title>
        <description>Tapentadol-O-glucuronide is the metabolite of tapentadol. Metabolites are sometimes referred to as &quot;breakdown products&quot;. The body alters the administered medication to a metabolite so that it can be more easily or quickly removed from the body. Serum samples (frequent sampling) were drawn at 0.25, 0.5, 1, 2, 4, 6, 11, and 15 hours. The concentration of tapentadol-O-glucuronide (metabolite) is assessed to study absorption and distribution.&#xD;
The maximum concentration is derived from the Area Under the Curve, from dose to 15 hours (AUC 0-15). It is the highest amount of metabolite observed in the blood sample.</description>
        <time_frame>up to 15 hours</time_frame>
        <population>The protocol planned that this analysis would only be performed for the adolescent participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Tapentadol-O-glucuronide Non-Compartmental PK Parameter: Cmax</title>
            <description>Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
        </group_list>
        <measure>
          <title>Non-Compartmental Pharmacokinetic (PK) Parameter: Cmax (Maximum Concentration) of Tapentadol-O-glucuronide After a Single Dose of Tapentadol in Adolescents (Age 12 to Less Than 18 Years).</title>
          <description>Tapentadol-O-glucuronide is the metabolite of tapentadol. Metabolites are sometimes referred to as &quot;breakdown products&quot;. The body alters the administered medication to a metabolite so that it can be more easily or quickly removed from the body. Serum samples (frequent sampling) were drawn at 0.25, 0.5, 1, 2, 4, 6, 11, and 15 hours. The concentration of tapentadol-O-glucuronide (metabolite) is assessed to study absorption and distribution.&#xD;
The maximum concentration is derived from the Area Under the Curve, from dose to 15 hours (AUC 0-15). It is the highest amount of metabolite observed in the blood sample.</description>
          <population>The protocol planned that this analysis would only be performed for the adolescent participants.</population>
          <units>nanogramsg/millilitre</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1487" spread="495"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Non-Compartmental Pharmacokinetic (PK) Parameter: Time to Maximum Concentration (Tmax) of Tapentadol-O-glucuronide After a Single Dose of Tapentadol in Adolescents (Age 12 to Less Than 18).</title>
        <description>Tapentadol-O-glucuronide is the metabolite of tapentadol. Metabolites are sometimes referred to as &quot;breakdown products&quot;. The body alters the administered medication to a metabolite so that it can be more easily or quickly removed from the body. Serum samples for pharmacokinetic analysis were obtained using frequent sampling techniques in participants 12 years to less than 18 years of age. The time to maximum concentration is derived from the area under the curve from dose to 15 hours (AUC 0-15). The Tmax is the time after dosing at which the maximum concentration of the tapentadol-O-glucuronide (metabolite) occurs. Serum samples (frequent sampling) were drawn at 0.25, 0.5, 1, 2, 4, 6, 11, and 15 hours.</description>
        <time_frame>up to 15 hours</time_frame>
        <population>The protocol planned that this analysis would only be performed for the adolescent participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Tapentadol-O-glucuronide Non-Compartmental PK Parameter: Tmax</title>
            <description>Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
        </group_list>
        <measure>
          <title>Non-Compartmental Pharmacokinetic (PK) Parameter: Time to Maximum Concentration (Tmax) of Tapentadol-O-glucuronide After a Single Dose of Tapentadol in Adolescents (Age 12 to Less Than 18).</title>
          <description>Tapentadol-O-glucuronide is the metabolite of tapentadol. Metabolites are sometimes referred to as &quot;breakdown products&quot;. The body alters the administered medication to a metabolite so that it can be more easily or quickly removed from the body. Serum samples for pharmacokinetic analysis were obtained using frequent sampling techniques in participants 12 years to less than 18 years of age. The time to maximum concentration is derived from the area under the curve from dose to 15 hours (AUC 0-15). The Tmax is the time after dosing at which the maximum concentration of the tapentadol-O-glucuronide (metabolite) occurs. Serum samples (frequent sampling) were drawn at 0.25, 0.5, 1, 2, 4, 6, 11, and 15 hours.</description>
          <population>The protocol planned that this analysis would only be performed for the adolescent participants.</population>
          <units>hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.70" spread="1.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hematology Safety Laboratory Assessments: Hemoglobin Concentration</title>
        <description>The hemoglobin test is a commonly ordered blood test and was done as part of a complete blood count (CBC). It is routinely done before and after surgery to check for anemia, the presence of chronic kidney disease or other chronic medical problems. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.</description>
        <time_frame>Enrollment Visit; Visit 2 and Discharge Visit</time_frame>
        <population>The protocol pre-specified that the young and very young children will be reported as one group.&#xD;
(Adolescents Group at Visit 3: N=20 one participant with missing data; Young and Very Young Children Group at Visits 2 and 3: N=16 one participant with missing data at each of these visits).</population>
        <group_list>
          <group group_id="O1">
            <title>Hemoglobin Concentration: Adolescents</title>
            <description>Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
          <group group_id="O2">
            <title>Hemoglobin Concentration: Older Children</title>
            <description>Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
          <group group_id="O3">
            <title>Hemoglobin Concentration: Young and Very Young Children</title>
            <description>Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
        </group_list>
        <measure>
          <title>Hematology Safety Laboratory Assessments: Hemoglobin Concentration</title>
          <description>The hemoglobin test is a commonly ordered blood test and was done as part of a complete blood count (CBC). It is routinely done before and after surgery to check for anemia, the presence of chronic kidney disease or other chronic medical problems. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.</description>
          <population>The protocol pre-specified that the young and very young children will be reported as one group.&#xD;
(Adolescents Group at Visit 3: N=20 one participant with missing data; Young and Very Young Children Group at Visits 2 and 3: N=16 one participant with missing data at each of these visits).</population>
          <units>g/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="151.10" spread="13.82"/>
                    <measurement group_id="O2" value="140.04" spread="6.66"/>
                    <measurement group_id="O3" value="127.47" spread="7.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="145.67" spread="21.44"/>
                    <measurement group_id="O2" value="128.64" spread="7.88"/>
                    <measurement group_id="O3" value="121.75" spread="7.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="139.00" spread="19.20"/>
                    <measurement group_id="O2" value="126.54" spread="9.10"/>
                    <measurement group_id="O3" value="117.00" spread="7.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hematology Safety Laboratory Assessments: Hematocrit</title>
        <description>Hematocrit is a blood test that measures the percentage of the volume of whole blood that is made up of red blood cells (RBC). This measurement depends on the number of red blood cells and the size of red blood cells. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.</description>
        <time_frame>Enrollment Visit; Visit 2 and Discharge Visit</time_frame>
        <population>The protocol pre-specified that the young and very young children will be reported as one group.&#xD;
(Adolescents Group at Visit 3: N=20 one participant with missing data; Young and Very Young Children Group at Visits 2 and 3: N=16 one participant with missing data at each of these visits).</population>
        <group_list>
          <group group_id="O1">
            <title>Hematocrit: Adolescents</title>
            <description>Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
          <group group_id="O2">
            <title>Hematocrit: Older Children</title>
            <description>Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
          <group group_id="O3">
            <title>Hematocrit: Young and Very Young Children</title>
            <description>Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
        </group_list>
        <measure>
          <title>Hematology Safety Laboratory Assessments: Hematocrit</title>
          <description>Hematocrit is a blood test that measures the percentage of the volume of whole blood that is made up of red blood cells (RBC). This measurement depends on the number of red blood cells and the size of red blood cells. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.</description>
          <population>The protocol pre-specified that the young and very young children will be reported as one group.&#xD;
(Adolescents Group at Visit 3: N=20 one participant with missing data; Young and Very Young Children Group at Visits 2 and 3: N=16 one participant with missing data at each of these visits).</population>
          <units>fraction of blood volume</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.436" spread="0.037"/>
                    <measurement group_id="O2" value="0.400" spread="0.018"/>
                    <measurement group_id="O3" value="0.368" spread="0.018"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.421" spread="0.060"/>
                    <measurement group_id="O2" value="0.372" spread="0.024"/>
                    <measurement group_id="O3" value="0.363" spread="0.023"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.402" spread="0.054"/>
                    <measurement group_id="O2" value="0.364" spread="0.025"/>
                    <measurement group_id="O3" value="0.356" spread="0.022"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hematology Safety Laboratory Assessments: Erythrocyte Mean Corpuscular Volume (Mean Corpuscular Volume)</title>
        <description>Erythrocyte Mean Corpuscular volume is a measurement of the average size of Red Blood Cells (RBC). It is also referred to as Mean Corpuscular Volume. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.</description>
        <time_frame>Enrollment Visit; Visit 2 and Discharge Visit</time_frame>
        <population>The protocol pre-specified that the young and very young children will be reported as one group.&#xD;
(Adolescents Group at Visit 3: N=20 one participant with missing data; Young and Very Young Children Group at Visits 2 and 3: N=16 one participant with missing data at each of these visits).</population>
        <group_list>
          <group group_id="O1">
            <title>Mean Corpuscular Volume: Adolescents</title>
            <description>Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
          <group group_id="O2">
            <title>Mean Corpuscular Volume: Older Children</title>
            <description>Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
          <group group_id="O3">
            <title>Mean Corpuscular Volume: Young and Very Young Children</title>
            <description>Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
        </group_list>
        <measure>
          <title>Hematology Safety Laboratory Assessments: Erythrocyte Mean Corpuscular Volume (Mean Corpuscular Volume)</title>
          <description>Erythrocyte Mean Corpuscular volume is a measurement of the average size of Red Blood Cells (RBC). It is also referred to as Mean Corpuscular Volume. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.</description>
          <population>The protocol pre-specified that the young and very young children will be reported as one group.&#xD;
(Adolescents Group at Visit 3: N=20 one participant with missing data; Young and Very Young Children Group at Visits 2 and 3: N=16 one participant with missing data at each of these visits).</population>
          <units>fL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86.1" spread="2.9"/>
                    <measurement group_id="O2" value="82.3" spread="3.1"/>
                    <measurement group_id="O3" value="79.6" spread="3.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86.5" spread="2.1"/>
                    <measurement group_id="O2" value="83.1" spread="3.5"/>
                    <measurement group_id="O3" value="81.8" spread="3.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86.9" spread="3.5"/>
                    <measurement group_id="O2" value="83.1" spread="3.5"/>
                    <measurement group_id="O3" value="82.7" spread="3.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hematology Safety Laboratory Assessments: Platelet Count</title>
        <description>Platelets are cell fragments that are vital for normal blood clotting. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.</description>
        <time_frame>Enrollment Visit; Visit 2 and Discharge Visit</time_frame>
        <population>The protocol pre-specified that the young and very young children will be reported as one group.&#xD;
(Adolescents Group at Visit 3: N=20 one participant with missing data; Young and Very Young Children Group at Visits 2 and 3: N=16 one participant with missing data at each of these visits).</population>
        <group_list>
          <group group_id="O1">
            <title>Platelet Count: Adolescents</title>
            <description>Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
          <group group_id="O2">
            <title>Platelet Count: Older Children</title>
            <description>Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
          <group group_id="O3">
            <title>Platelet Count: Young and Very Young Children</title>
            <description>Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
        </group_list>
        <measure>
          <title>Hematology Safety Laboratory Assessments: Platelet Count</title>
          <description>Platelets are cell fragments that are vital for normal blood clotting. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.</description>
          <population>The protocol pre-specified that the young and very young children will be reported as one group.&#xD;
(Adolescents Group at Visit 3: N=20 one participant with missing data; Young and Very Young Children Group at Visits 2 and 3: N=16 one participant with missing data at each of these visits).</population>
          <units>GI/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="297.0" spread="59.8"/>
                    <measurement group_id="O2" value="347.1" spread="86.2"/>
                    <measurement group_id="O3" value="357.4" spread="67.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="266.1" spread="73.0"/>
                    <measurement group_id="O2" value="303.4" spread="73.9"/>
                    <measurement group_id="O3" value="312.6" spread="111.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="263.9" spread="57.9"/>
                    <measurement group_id="O2" value="316.9" spread="71.3"/>
                    <measurement group_id="O3" value="307.3" spread="50.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hematology Safety Laboratory Assessments: Leukocyte Concentration</title>
        <description>Leukocytes are also called white blood cells (WBC). These were measured to assess immune function. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.</description>
        <time_frame>Enrollment Visit; Visit 2 and Discharge Visit</time_frame>
        <population>The protocol pre-specified that the young and very young children will be reported as one group.&#xD;
(Adolescents Group at Visit 3: N=20 one participant with missing data; Young and Very Young Children Group at Visits 2 and 3: N=16 one participant with missing data at each visit).</population>
        <group_list>
          <group group_id="O1">
            <title>Leukocyte Concentration: Adolescents</title>
            <description>Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
          <group group_id="O2">
            <title>Leukocyte Concentration: Older Children</title>
            <description>Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
          <group group_id="O3">
            <title>Leukocyte Concentration: Young and Very Young Children</title>
            <description>Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
        </group_list>
        <measure>
          <title>Hematology Safety Laboratory Assessments: Leukocyte Concentration</title>
          <description>Leukocytes are also called white blood cells (WBC). These were measured to assess immune function. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.</description>
          <population>The protocol pre-specified that the young and very young children will be reported as one group.&#xD;
(Adolescents Group at Visit 3: N=20 one participant with missing data; Young and Very Young Children Group at Visits 2 and 3: N=16 one participant with missing data at each visit).</population>
          <units>GI/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.631" spread="1.682"/>
                    <measurement group_id="O2" value="7.594" spread="3.984"/>
                    <measurement group_id="O3" value="6.555" spread="1.278"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.537" spread="2.514"/>
                    <measurement group_id="O2" value="12.509" spread="4.209"/>
                    <measurement group_id="O3" value="10.751" spread="3.272"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.052" spread="3.253"/>
                    <measurement group_id="O2" value="14.806" spread="4.031"/>
                    <measurement group_id="O3" value="13.160" spread="2.907"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Biochemistry Safety Laboratory Parameters: Blood Glucose Concentration</title>
        <description>A blood glucose test measures the amount of a sugar called glucose in blood. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.</description>
        <time_frame>Enrollment Visit; Visit 2 and Discharge Visit</time_frame>
        <population>The protocol pre-specified that the young and very young children will be reported as one group.&#xD;
(Adolescents Group at Visit 3: N=20 one participant with missing data; Young and Very Young Children Group at Visit 3: N=16 one participant with missing data).</population>
        <group_list>
          <group group_id="O1">
            <title>Blood Glucose Concentration: Adolescents</title>
            <description>Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
          <group group_id="O2">
            <title>Blood Glucose Concentration: Older Children</title>
            <description>Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
          <group group_id="O3">
            <title>Blood Glucose Concentration: Young and Very Young Children</title>
            <description>Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
        </group_list>
        <measure>
          <title>Biochemistry Safety Laboratory Parameters: Blood Glucose Concentration</title>
          <description>A blood glucose test measures the amount of a sugar called glucose in blood. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.</description>
          <population>The protocol pre-specified that the young and very young children will be reported as one group.&#xD;
(Adolescents Group at Visit 3: N=20 one participant with missing data; Young and Very Young Children Group at Visit 3: N=16 one participant with missing data).</population>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.77" spread="0.51"/>
                    <measurement group_id="O2" value="4.81" spread="0.52"/>
                    <measurement group_id="O3" value="5.01" spread="1.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.10" spread="0.68"/>
                    <measurement group_id="O2" value="6.39" spread="1.49"/>
                    <measurement group_id="O3" value="5.89" spread="1.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.51" spread="0.90"/>
                    <measurement group_id="O2" value="5.69" spread="1.21"/>
                    <measurement group_id="O3" value="4.90" spread="0.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Biochemistry Safety Laboratory Parameters: Blood Sodium Concentration</title>
        <description>Sodium is required by the body for the body to function properly. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.</description>
        <time_frame>Enrollment Visit; Visit 2 and Discharge Visit</time_frame>
        <population>The protocol pre-specified that the young and very young children will be reported as one group.&#xD;
(Adolescents Group at Visit 3: N=20 one participant with missing data; Young and Very Young Children Group at Visit 3: N=16 one participant with missing data).</population>
        <group_list>
          <group group_id="O1">
            <title>Blood Sodium Concentration: Adolescents</title>
            <description>Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
          <group group_id="O2">
            <title>Blood Sodium Concentration: Older Children</title>
            <description>Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
          <group group_id="O3">
            <title>Blood Sodium Concentration: Young and Very Young Children</title>
            <description>Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
        </group_list>
        <measure>
          <title>Biochemistry Safety Laboratory Parameters: Blood Sodium Concentration</title>
          <description>Sodium is required by the body for the body to function properly. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.</description>
          <population>The protocol pre-specified that the young and very young children will be reported as one group.&#xD;
(Adolescents Group at Visit 3: N=20 one participant with missing data; Young and Very Young Children Group at Visit 3: N=16 one participant with missing data).</population>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="140.9" spread="1.4"/>
                    <measurement group_id="O2" value="140.4" spread="2.1"/>
                    <measurement group_id="O3" value="139.3" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="140.3" spread="1.5"/>
                    <measurement group_id="O2" value="138.4" spread="2.6"/>
                    <measurement group_id="O3" value="139.1" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="138.1" spread="1.2"/>
                    <measurement group_id="O2" value="138.7" spread="1.8"/>
                    <measurement group_id="O3" value="138.8" spread="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Biochemistry Safety Laboratory Parameters: Blood Potassium Concentration</title>
        <description>Potassium is a mineral that the body needs to work normally. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.</description>
        <time_frame>Enrollment Visit; Visit 2 and Discharge Visit</time_frame>
        <population>The protocol pre-specified that the young and very young children will be reported as one group.&#xD;
(Adolescents Group at Visit 3: N=20 one participant with missing data; Young and Very Young Children Group at Visit 3: N=16 one participant with missing data).</population>
        <group_list>
          <group group_id="O1">
            <title>Blood Potassium Concentration: Adolescents</title>
            <description>Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
          <group group_id="O2">
            <title>Blood Potassium Concentration: Older Children</title>
            <description>Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
          <group group_id="O3">
            <title>Blood Potassium Concentration: Young and Very Young Children</title>
            <description>Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
        </group_list>
        <measure>
          <title>Biochemistry Safety Laboratory Parameters: Blood Potassium Concentration</title>
          <description>Potassium is a mineral that the body needs to work normally. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.</description>
          <population>The protocol pre-specified that the young and very young children will be reported as one group.&#xD;
(Adolescents Group at Visit 3: N=20 one participant with missing data; Young and Very Young Children Group at Visit 3: N=16 one participant with missing data).</population>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.20" spread="0.31"/>
                    <measurement group_id="O2" value="4.20" spread="0.32"/>
                    <measurement group_id="O3" value="4.09" spread="0.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.90" spread="0.36"/>
                    <measurement group_id="O2" value="3.83" spread="0.32"/>
                    <measurement group_id="O3" value="4.04" spread="0.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.94" spread="0.26"/>
                    <measurement group_id="O2" value="3.93" spread="0.29"/>
                    <measurement group_id="O3" value="3.93" spread="0.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Biochemistry Safety Laboratory Parameters: Blood Calcium Concentration</title>
        <description>All cells need calcium in order to function. In the study there were 3 planned safety blood draws for routine blood tests. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.</description>
        <time_frame>Enrollment Visit; Visit 2 and Discharge Visit</time_frame>
        <population>The protocol pre-specified that the young and very young children will be reported as one group.&#xD;
(Adolescents Group at Visit 3: N=20 one participant with missing data; Older children Group at Visit 2: N=27 one participant with missing data; Young and Very Young Children Group at Visit 3: N=16 one participant with missing data).</population>
        <group_list>
          <group group_id="O1">
            <title>Blood Calcium Concentration: Adolescents</title>
            <description>Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
          <group group_id="O2">
            <title>Blood Calcium Concentration: Older Children</title>
            <description>Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
          <group group_id="O3">
            <title>Blood Calcium Concentration: Young and Very Young Children</title>
            <description>Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
        </group_list>
        <measure>
          <title>Biochemistry Safety Laboratory Parameters: Blood Calcium Concentration</title>
          <description>All cells need calcium in order to function. In the study there were 3 planned safety blood draws for routine blood tests. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.</description>
          <population>The protocol pre-specified that the young and very young children will be reported as one group.&#xD;
(Adolescents Group at Visit 3: N=20 one participant with missing data; Older children Group at Visit 2: N=27 one participant with missing data; Young and Very Young Children Group at Visit 3: N=16 one participant with missing data).</population>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.455" spread="0.065"/>
                    <measurement group_id="O2" value="2.482" spread="0.100"/>
                    <measurement group_id="O3" value="2.519" spread="0.055"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.268" spread="0.166"/>
                    <measurement group_id="O2" value="2.267" spread="0.108"/>
                    <measurement group_id="O3" value="2.343" spread="0.160"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.359" spread="0.104"/>
                    <measurement group_id="O2" value="2.266" spread="0.157"/>
                    <measurement group_id="O3" value="2.369" spread="0.123"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Biochemistry Safety Laboratory Parameters: Blood Chloride Concentration</title>
        <description>Chloride with other electrolytes help keep the proper balance of body fluids and maintain the body's acid-base balance. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care</description>
        <time_frame>Enrollment Visit; Visit 2 and Discharge Visit</time_frame>
        <population>The protocol pre-specified that the young and very young children will be reported as one group.&#xD;
(Adolescents Group at Visit 3: N=20 one participant with missing data; Older children Group at Visit 2: N=27 one participant with missing data; Young and Very Young Children Group at Visit 3: N=16 one participant with missing data).</population>
        <group_list>
          <group group_id="O1">
            <title>Blood Chloride Concentration: Adolescents</title>
            <description>Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
          <group group_id="O2">
            <title>Blood Chloride Concentration: Older Children</title>
            <description>Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
          <group group_id="O3">
            <title>Blood Chloride Concentration: Young and Very Young Children</title>
            <description>Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
        </group_list>
        <measure>
          <title>Biochemistry Safety Laboratory Parameters: Blood Chloride Concentration</title>
          <description>Chloride with other electrolytes help keep the proper balance of body fluids and maintain the body's acid-base balance. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care</description>
          <population>The protocol pre-specified that the young and very young children will be reported as one group.&#xD;
(Adolescents Group at Visit 3: N=20 one participant with missing data; Older children Group at Visit 2: N=27 one participant with missing data; Young and Very Young Children Group at Visit 3: N=16 one participant with missing data).</population>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="103.3" spread="1.9"/>
                    <measurement group_id="O2" value="103.4" spread="2.2"/>
                    <measurement group_id="O3" value="103.8" spread="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="106.6" spread="2.2"/>
                    <measurement group_id="O2" value="104.9" spread="2.8"/>
                    <measurement group_id="O3" value="106.2" spread="3.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="103.0" spread="2.2"/>
                    <measurement group_id="O2" value="105.1" spread="2.6"/>
                    <measurement group_id="O3" value="105.1" spread="2.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Biochemistry Safety Laboratory Parameters: Blood Phosphate Concentration</title>
        <description>Phosphate is needed by the body. This test was done to see how much phosphate is in the blood. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.</description>
        <time_frame>Enrollment Visit; Visit 2 and Discharge Visit</time_frame>
        <population>The protocol pre-specified that the young and very young children will be reported as one group.&#xD;
(Adolescents Group at Visit 3: N=20 one participant with missing data; Young and Very Young Children Group at Visit 3: N=16 one participant with missing data).</population>
        <group_list>
          <group group_id="O1">
            <title>Blood Phosphate Concentration: Adolescents</title>
            <description>Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
          <group group_id="O2">
            <title>Blood Phosphate Concentration: Older Children</title>
            <description>Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
          <group group_id="O3">
            <title>Blood Phosphate Concentration: Young and Very Young Children</title>
            <description>Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
        </group_list>
        <measure>
          <title>Biochemistry Safety Laboratory Parameters: Blood Phosphate Concentration</title>
          <description>Phosphate is needed by the body. This test was done to see how much phosphate is in the blood. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.</description>
          <population>The protocol pre-specified that the young and very young children will be reported as one group.&#xD;
(Adolescents Group at Visit 3: N=20 one participant with missing data; Young and Very Young Children Group at Visit 3: N=16 one participant with missing data).</population>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.384" spread="0.185"/>
                    <measurement group_id="O2" value="1.560" spread="0.146"/>
                    <measurement group_id="O3" value="1.689" spread="0.165"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.234" spread="0.194"/>
                    <measurement group_id="O2" value="1.248" spread="0.241"/>
                    <measurement group_id="O3" value="1.412" spread="0.179"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.500" spread="0.199"/>
                    <measurement group_id="O2" value="1.535" spread="0.178"/>
                    <measurement group_id="O3" value="1.611" spread="0.181"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Biochemistry Safety Laboratory Parameters: Blood Urea Nitrogen (BUN) Concentration</title>
        <description>This test is to measure the amount of urea nitrogen in the blood. It was used to test liver and kidney function. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.</description>
        <time_frame>Enrollment Visit; Visit 2 and Discharge Visit</time_frame>
        <population>The protocol pre-specified that the young and very young children will be reported as one group.&#xD;
(Adolescents Group at Visit 3: N=20 one participant with missing data; Young and Very Young Children Group at Visit 3: N=16 one participant with missing data).</population>
        <group_list>
          <group group_id="O1">
            <title>BUN Concentration: Adolescents</title>
            <description>Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
          <group group_id="O2">
            <title>BUN Concentration: Older Children</title>
            <description>Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
          <group group_id="O3">
            <title>BUN Concentration: Young and Very Young Children</title>
            <description>Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
        </group_list>
        <measure>
          <title>Biochemistry Safety Laboratory Parameters: Blood Urea Nitrogen (BUN) Concentration</title>
          <description>This test is to measure the amount of urea nitrogen in the blood. It was used to test liver and kidney function. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.</description>
          <population>The protocol pre-specified that the young and very young children will be reported as one group.&#xD;
(Adolescents Group at Visit 3: N=20 one participant with missing data; Young and Very Young Children Group at Visit 3: N=16 one participant with missing data).</population>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.55" spread="1.19"/>
                    <measurement group_id="O2" value="4.47" spread="1.30"/>
                    <measurement group_id="O3" value="5.15" spread="1.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.54" spread="1.32"/>
                    <measurement group_id="O2" value="4.38" spread="0.95"/>
                    <measurement group_id="O3" value="4.19" spread="0.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.88" spread="0.98"/>
                    <measurement group_id="O2" value="4.31" spread="1.21"/>
                    <measurement group_id="O3" value="4.11" spread="0.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Biochemistry Safety Laboratory Parameters: Creatinine Concentration</title>
        <description>Creatinine is removed from the body entirely by the kidneys. If kidney function is not normal, creatinine level increases in the blood. In the study there were 3 planned safety blood draws for routine blood tests. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.</description>
        <time_frame>Enrollment Visit; Visit 2 and Discharge Visit</time_frame>
        <population>The protocol pre-specified that the young and very young children will be reported as one group.&#xD;
(Adolescents Group at Visit 3: N=20 one participant with missing data; Young and Very Young Children Group at Visit 3: N=16 one participant with missing data).</population>
        <group_list>
          <group group_id="O1">
            <title>Creatinine Concentration: Adolescents</title>
            <description>Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
          <group group_id="O2">
            <title>Creatinine Concentration: Older Children</title>
            <description>Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
          <group group_id="O3">
            <title>Creatinine Concentration: Young and Very Young Children</title>
            <description>Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
        </group_list>
        <measure>
          <title>Biochemistry Safety Laboratory Parameters: Creatinine Concentration</title>
          <description>Creatinine is removed from the body entirely by the kidneys. If kidney function is not normal, creatinine level increases in the blood. In the study there were 3 planned safety blood draws for routine blood tests. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.</description>
          <population>The protocol pre-specified that the young and very young children will be reported as one group.&#xD;
(Adolescents Group at Visit 3: N=20 one participant with missing data; Young and Very Young Children Group at Visit 3: N=16 one participant with missing data).</population>
          <units>µmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.3" spread="14.7"/>
                    <measurement group_id="O2" value="49.5" spread="6.2"/>
                    <measurement group_id="O3" value="35.6" spread="4.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67.8" spread="15.1"/>
                    <measurement group_id="O2" value="44.1" spread="9.3"/>
                    <measurement group_id="O3" value="31.6" spread="6.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68.6" spread="16.2"/>
                    <measurement group_id="O2" value="41.5" spread="8.0"/>
                    <measurement group_id="O3" value="33.0" spread="5.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Biochemistry Safety Laboratory Parameters: Aspartate Aminotransferase (AST) Enzyme Activity</title>
        <description>AST is considered to be one of the two most important tests to detect liver injury. During liver damage the enzyme is released into the blood. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.</description>
        <time_frame>Enrollment Visit; Visit 2 and Discharge Visit</time_frame>
        <population>The protocol pre-specified that the young and very young children will be reported as one group.&#xD;
(Adolescents Group at Visit 3: N=20 one participant with missing data; Older children at Visits 2 and 3: N=26 two participants with missing data; Young and Very Young Children Group at Visits 1 and 3: N=16 one participant with missing data).</population>
        <group_list>
          <group group_id="O1">
            <title>AST Activity: Adolescents</title>
            <description>Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
          <group group_id="O2">
            <title>AST Activity: Older Children</title>
            <description>Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
          <group group_id="O3">
            <title>AST Activity: Young and Very Young Children</title>
            <description>Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
        </group_list>
        <measure>
          <title>Biochemistry Safety Laboratory Parameters: Aspartate Aminotransferase (AST) Enzyme Activity</title>
          <description>AST is considered to be one of the two most important tests to detect liver injury. During liver damage the enzyme is released into the blood. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.</description>
          <population>The protocol pre-specified that the young and very young children will be reported as one group.&#xD;
(Adolescents Group at Visit 3: N=20 one participant with missing data; Older children at Visits 2 and 3: N=26 two participants with missing data; Young and Very Young Children Group at Visits 1 and 3: N=16 one participant with missing data).</population>
          <units>U/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.5" spread="5.1"/>
                    <measurement group_id="O2" value="27.9" spread="6.5"/>
                    <measurement group_id="O3" value="33.4" spread="3.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.6" spread="4.5"/>
                    <measurement group_id="O2" value="29.9" spread="5.1"/>
                    <measurement group_id="O3" value="37.9" spread="7.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.6" spread="12.9"/>
                    <measurement group_id="O2" value="30.2" spread="7.2"/>
                    <measurement group_id="O3" value="33.8" spread="4.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Biochemistry Safety Laboratory Parameters: Triglycerides Concentration</title>
        <description>Triglycerides are a group of fat. Triglycerides were measured as part of metabolic and cardiac assessments. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.</description>
        <time_frame>Enrollment Visit; Visit 2 and Discharge Visit</time_frame>
        <population>The protocol pre-specified that the young and very young children will be reported as one group.&#xD;
(Adolescents Group at Visit 3: N=20 one participant data missing; Older children Visits 2 and 3: N=27 and N=26 one and two participant data missing; Young and Very Young Children Group at Visits 2 and 3: N=16 one participant data missing).</population>
        <group_list>
          <group group_id="O1">
            <title>Triglycerides Concentration: Adolescents</title>
            <description>Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
          <group group_id="O2">
            <title>Triglycerides Concentration: Older Children</title>
            <description>Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
          <group group_id="O3">
            <title>Triglycerides Concentration: Young and Very Young Children</title>
            <description>Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
        </group_list>
        <measure>
          <title>Biochemistry Safety Laboratory Parameters: Triglycerides Concentration</title>
          <description>Triglycerides are a group of fat. Triglycerides were measured as part of metabolic and cardiac assessments. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.</description>
          <population>The protocol pre-specified that the young and very young children will be reported as one group.&#xD;
(Adolescents Group at Visit 3: N=20 one participant data missing; Older children Visits 2 and 3: N=27 and N=26 one and two participant data missing; Young and Very Young Children Group at Visits 2 and 3: N=16 one participant data missing).</population>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.118" spread="0.459"/>
                    <measurement group_id="O2" value="1.129" spread="0.495"/>
                    <measurement group_id="O3" value="1.223" spread="0.511"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.666" spread="0.318"/>
                    <measurement group_id="O2" value="0.499" spread="0.245"/>
                    <measurement group_id="O3" value="0.556" spread="0.173"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.634" spread="0.224"/>
                    <measurement group_id="O2" value="0.646" spread="0.225"/>
                    <measurement group_id="O3" value="0.789" spread="0.227"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Biochemistry Safety Laboratory Parameters: Serum Albumin Concentration</title>
        <description>Albumin is a protein made by the liver. Albumin prevents fluid leaking into the tissues. Albumin also transports many small molecules. Serum albumin was measured in the clear liquid portion of the blood called serum. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.</description>
        <time_frame>Enrollment Visit; Visit 2 and Discharge Visit</time_frame>
        <population>The protocol pre-specified that the young and very young children will be reported as one group.&#xD;
(Adolescents Group at Visit 3: N=20 one participant with missing data; Older children N=27 at Visit 1; Young and Very Young Children Group at Visit 3: N=16 one participant with missing data).</population>
        <group_list>
          <group group_id="O1">
            <title>Albumin Concentration: Adolescents</title>
            <description>Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
          <group group_id="O2">
            <title>Albumin Concentration: Older Children</title>
            <description>Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
          <group group_id="O3">
            <title>Albumin Concentration: Young and Very Young Children</title>
            <description>Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
        </group_list>
        <measure>
          <title>Biochemistry Safety Laboratory Parameters: Serum Albumin Concentration</title>
          <description>Albumin is a protein made by the liver. Albumin prevents fluid leaking into the tissues. Albumin also transports many small molecules. Serum albumin was measured in the clear liquid portion of the blood called serum. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.</description>
          <population>The protocol pre-specified that the young and very young children will be reported as one group.&#xD;
(Adolescents Group at Visit 3: N=20 one participant with missing data; Older children N=27 at Visit 1; Young and Very Young Children Group at Visit 3: N=16 one participant with missing data).</population>
          <units>g/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.4" spread="2.5"/>
                    <measurement group_id="O2" value="43.4" spread="3.0"/>
                    <measurement group_id="O3" value="42.6" spread="2.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.4" spread="3.1"/>
                    <measurement group_id="O2" value="37.1" spread="2.5"/>
                    <measurement group_id="O3" value="38.9" spread="3.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.4" spread="2.8"/>
                    <measurement group_id="O2" value="37.2" spread="3.5"/>
                    <measurement group_id="O3" value="37.5" spread="3.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Biochemistry Safety Laboratory Parameters: Urate in the Blood</title>
        <description>Uric acid (urate is the salt) is a chemical created when the body breaks down substances called purines. Most urate dissolves in blood and travels to the kidneys. From there, it passes out in the urine. The test is used to determine kidney function. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.</description>
        <time_frame>Enrollment Visit; Visit 2 and Discharge Visit</time_frame>
        <population>The protocol pre-specified that the young and very young children will be reported as one group.&#xD;
(Adolescents Group at Visit 3: N=20 one participant with missing data; Young and Very Young Children Group at Visit 3: N=16 one participant with missing data).</population>
        <group_list>
          <group group_id="O1">
            <title>Urate: Adolescents</title>
            <description>Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
          <group group_id="O2">
            <title>Urate: Older Children</title>
            <description>Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
          <group group_id="O3">
            <title>Urate: Young and Very Young Children</title>
            <description>Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
        </group_list>
        <measure>
          <title>Biochemistry Safety Laboratory Parameters: Urate in the Blood</title>
          <description>Uric acid (urate is the salt) is a chemical created when the body breaks down substances called purines. Most urate dissolves in blood and travels to the kidneys. From there, it passes out in the urine. The test is used to determine kidney function. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.</description>
          <population>The protocol pre-specified that the young and very young children will be reported as one group.&#xD;
(Adolescents Group at Visit 3: N=20 one participant with missing data; Young and Very Young Children Group at Visit 3: N=16 one participant with missing data).</population>
          <units>µmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="301.62" spread="69.35"/>
                    <measurement group_id="O2" value="228.32" spread="41.87"/>
                    <measurement group_id="O3" value="214.82" spread="39.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="305.57" spread="85.12"/>
                    <measurement group_id="O2" value="225.39" spread="44.74"/>
                    <measurement group_id="O3" value="205.65" spread="34.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="291.45" spread="69.06"/>
                    <measurement group_id="O2" value="213.68" spread="57.96"/>
                    <measurement group_id="O3" value="195.94" spread="48.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Biochemistry Safety Laboratory Parameters: Calculated Glomerular Filtration Rate</title>
        <description>Glomerular filtration rate (GFR) was done to check how well the kidneys are working. It estimates how much blood passes through the glomeruli in the kidney each minute. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.</description>
        <time_frame>Enrollment Visit; Visit 2 and Discharge Visit</time_frame>
        <population>The protocol pre-specified that the young and very young children will be reported as one group.&#xD;
(Adolescents Group at Visit 3: N=20 one participant with missing data; Young and Very Young Children Group at Visit 3: N=16 one participant with missing data).</population>
        <group_list>
          <group group_id="O1">
            <title>Glomerular Filtration Rate: Adolescents</title>
            <description>Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
          <group group_id="O2">
            <title>Glomerular Filtration Rate: Older Children</title>
            <description>Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
          <group group_id="O3">
            <title>Glomerular Filtration Rate: Young and Very Young Children</title>
            <description>Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
        </group_list>
        <measure>
          <title>Biochemistry Safety Laboratory Parameters: Calculated Glomerular Filtration Rate</title>
          <description>Glomerular filtration rate (GFR) was done to check how well the kidneys are working. It estimates how much blood passes through the glomeruli in the kidney each minute. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.</description>
          <population>The protocol pre-specified that the young and very young children will be reported as one group.&#xD;
(Adolescents Group at Visit 3: N=20 one participant with missing data; Young and Very Young Children Group at Visit 3: N=16 one participant with missing data).</population>
          <units>mL/min/1.73m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="133.6" spread="20.7"/>
                    <measurement group_id="O2" value="133.9" spread="16.6"/>
                    <measurement group_id="O3" value="141.5" spread="18.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="146.6" spread="25.2"/>
                    <measurement group_id="O2" value="155.1" spread="38.0"/>
                    <measurement group_id="O3" value="166.9" spread="42.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="142.6" spread="23.3"/>
                    <measurement group_id="O2" value="158.7" spread="31.5"/>
                    <measurement group_id="O3" value="164.0" spread="37.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Biochemistry Safety Laboratory Parameters: Urine Specific Gravity</title>
        <description>This test was used to test for the water balance and urine concentration. A urine sample was tested right away. A dipstick with a color-sensitive pad was used. The color the dipstick changes and the specific gravity of the urine was read off the color chart. In the study there were 2 planned safety urine collections. At Visit 1 in the enrollment period, after consent and assent obtained. The second sample was obtained at Visit 3 prior to discharge from the hospital. The discharge visit was as per standard of care.</description>
        <time_frame>Enrollment Visit and Discharge Visit</time_frame>
        <population>The protocol pre-specified that the young and very young children will be reported as one group.&#xD;
(Young and Very Young Children Group at Visits 1: N=9 thus 8 participants with missing data; at Visit 3: N=7 thus 10 participants with missing data).</population>
        <group_list>
          <group group_id="O1">
            <title>Specific Gravity Urine: Adolescents</title>
            <description>Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
          <group group_id="O2">
            <title>Specific Gravity Urine: Older Children</title>
            <description>Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
          <group group_id="O3">
            <title>Specific Gravity Urine: Young and Very Young Children</title>
            <description>Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
        </group_list>
        <measure>
          <title>Biochemistry Safety Laboratory Parameters: Urine Specific Gravity</title>
          <description>This test was used to test for the water balance and urine concentration. A urine sample was tested right away. A dipstick with a color-sensitive pad was used. The color the dipstick changes and the specific gravity of the urine was read off the color chart. In the study there were 2 planned safety urine collections. At Visit 1 in the enrollment period, after consent and assent obtained. The second sample was obtained at Visit 3 prior to discharge from the hospital. The discharge visit was as per standard of care.</description>
          <population>The protocol pre-specified that the young and very young children will be reported as one group.&#xD;
(Young and Very Young Children Group at Visits 1: N=9 thus 8 participants with missing data; at Visit 3: N=7 thus 10 participants with missing data).</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.025" spread="0.007"/>
                    <measurement group_id="O2" value="1.024" spread="0.004"/>
                    <measurement group_id="O3" value="1.021" spread="0.007"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.022" spread="0.007"/>
                    <measurement group_id="O2" value="1.024" spread="0.004"/>
                    <measurement group_id="O3" value="1.024" spread="0.002"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Biochemistry Safety Laboratory Parameters: Urine pH (Acid, Alkalinity) Test</title>
        <description>A urine sample was tested right away. A dipstick made with a color-sensitive pad was used. The color indicated the acidity of the urine. In the study there were 2 planned safety urine collections. At Visit 1 in the enrollment period, after consent and assent obtained. The second sample was obtained at Visit 3 prior to discharge from the hospital. The discharge visit was as per standard of care.</description>
        <time_frame>Enrollment Visit and Discharge Visit</time_frame>
        <population>The protocol pre-specified that the young and very young children will be reported as one group.&#xD;
(Young and Very Young Children Group at Visits 1: N=9 thus 8 participants with missing data; at Visit 3: N=7 thus 10 participants with missing data).</population>
        <group_list>
          <group group_id="O1">
            <title>Urine pH: Adolescents</title>
            <description>Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
          <group group_id="O2">
            <title>Urine pH: Older Children</title>
            <description>Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
          <group group_id="O3">
            <title>Urine pH: Young and Very Young Children</title>
            <description>Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
        </group_list>
        <measure>
          <title>Biochemistry Safety Laboratory Parameters: Urine pH (Acid, Alkalinity) Test</title>
          <description>A urine sample was tested right away. A dipstick made with a color-sensitive pad was used. The color indicated the acidity of the urine. In the study there were 2 planned safety urine collections. At Visit 1 in the enrollment period, after consent and assent obtained. The second sample was obtained at Visit 3 prior to discharge from the hospital. The discharge visit was as per standard of care.</description>
          <population>The protocol pre-specified that the young and very young children will be reported as one group.&#xD;
(Young and Very Young Children Group at Visits 1: N=9 thus 8 participants with missing data; at Visit 3: N=7 thus 10 participants with missing data).</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.2" spread="0.5"/>
                    <measurement group_id="O2" value="6.5" spread="0.4"/>
                    <measurement group_id="O3" value="6.2" spread="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.1" spread="0.2"/>
                    <measurement group_id="O2" value="6.2" spread="0.4"/>
                    <measurement group_id="O3" value="6.4" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Biochemistry Safety Laboratory Parameters: Liver Function Test - Alanine Aminotransferase (ALT) Enzyme Activity</title>
        <description>This test was done in combination with other tests (such as AST, ALP, and bilirubin) to diagnose and monitor the liver function. In the study there were 3 planned safety blood draws for routine blood tests. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.</description>
        <time_frame>Enrollment Visit, Visit 2 and Discharge Visit</time_frame>
        <population>The protocol pre-specified that the young and very young children will be reported as one group.&#xD;
(Adolescents Group at Visit 3: N=19 two participants with missing data; Young and Very Young Children Group at Visit 3: N=16 one participant with missing data).</population>
        <group_list>
          <group group_id="O1">
            <title>ALT Activity: Adolescents</title>
            <description>Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
          <group group_id="O2">
            <title>ALT Activity: Older Children</title>
            <description>Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
          <group group_id="O3">
            <title>ALT Activity: Young &amp; Very Young Children</title>
            <description>Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
        </group_list>
        <measure>
          <title>Biochemistry Safety Laboratory Parameters: Liver Function Test - Alanine Aminotransferase (ALT) Enzyme Activity</title>
          <description>This test was done in combination with other tests (such as AST, ALP, and bilirubin) to diagnose and monitor the liver function. In the study there were 3 planned safety blood draws for routine blood tests. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.</description>
          <population>The protocol pre-specified that the young and very young children will be reported as one group.&#xD;
(Adolescents Group at Visit 3: N=19 two participants with missing data; Young and Very Young Children Group at Visit 3: N=16 one participant with missing data).</population>
          <units>U/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.2" spread="6.3"/>
                    <measurement group_id="O2" value="15.9" spread="4.1"/>
                    <measurement group_id="O3" value="16.4" spread="3.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.1" spread="4.6"/>
                    <measurement group_id="O2" value="15.7" spread="3.4"/>
                    <measurement group_id="O3" value="17.9" spread="5.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.2" spread="4.5"/>
                    <measurement group_id="O2" value="15.4" spread="3.4"/>
                    <measurement group_id="O3" value="17.1" spread="4.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Biochemistry Safety Laboratory Parameters: Liver Function Test - Gamma-Glutamyl Transferase (GGT) Enzyme Activity</title>
        <description>The gamma-glutamyl transferase (GGT) test was used in combination with the alkaline phosphatase (ALP) test. Both ALP and GGT can be elevated in bile duct or liver complications. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.</description>
        <time_frame>Enrollment Visit, Visit 2 and Discharge Visit</time_frame>
        <population>The protocol pre-specified that the young and very young children will be reported as one group.&#xD;
(Adolescents Group at Visit 2 and 3: N=20 one participant with missing data; Older Children at Visit 2: N=27 one participant with missing data; Young and Very Young Children Group at Visit 2: N=16 one participant with missing data).</population>
        <group_list>
          <group group_id="O1">
            <title>GGT Activity: Adolescents</title>
            <description>Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
          <group group_id="O2">
            <title>GGT Activity: Older Children</title>
            <description>Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
          <group group_id="O3">
            <title>GGT Activity: Young &amp; Very Young Children</title>
            <description>Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
        </group_list>
        <measure>
          <title>Biochemistry Safety Laboratory Parameters: Liver Function Test - Gamma-Glutamyl Transferase (GGT) Enzyme Activity</title>
          <description>The gamma-glutamyl transferase (GGT) test was used in combination with the alkaline phosphatase (ALP) test. Both ALP and GGT can be elevated in bile duct or liver complications. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.</description>
          <population>The protocol pre-specified that the young and very young children will be reported as one group.&#xD;
(Adolescents Group at Visit 2 and 3: N=20 one participant with missing data; Older Children at Visit 2: N=27 one participant with missing data; Young and Very Young Children Group at Visit 2: N=16 one participant with missing data).</population>
          <units>U/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.0" spread="4.0"/>
                    <measurement group_id="O2" value="10.6" spread="2.9"/>
                    <measurement group_id="O3" value="9.4" spread="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.4" spread="3.9"/>
                    <measurement group_id="O2" value="8.7" spread="2.0"/>
                    <measurement group_id="O3" value="8.6" spread="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.8" spread="4.2"/>
                    <measurement group_id="O2" value="8.8" spread="1.9"/>
                    <measurement group_id="O3" value="8.3" spread="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Biochemistry Safety Laboratory Parameters: Liver Function Test - Bilirubin Concentration</title>
        <description>Old red blood cells are replaced by new blood cells every day. Bilirubin is made by the body when the old blood cells are removed. The concentration of bilirubin in the blood measures liver function. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.</description>
        <time_frame>Enrollment Visit, Visit 2 and Discharge Visit</time_frame>
        <population>The protocol pre-specified that the young and very young children will be reported as one group.&#xD;
(Adolescents-Visit 2 &amp; 3: N=20 - 1 participant with data missing; Older Children-Visit 1 &amp; 2: N=26 thus 2 participants with data missing; Young and Very Young Children-Visits 1 &amp; 3: N=12 (5 with data missing) &amp; at Visit 2 N=9 (8 with data missing).</population>
        <group_list>
          <group group_id="O1">
            <title>Bilirubin Concentration: Adolescents</title>
            <description>Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
          <group group_id="O2">
            <title>Bilirubin Concentration: Older Children</title>
            <description>Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
          <group group_id="O3">
            <title>Bilirubin Concentration: Young &amp; Very Young Children</title>
            <description>Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
        </group_list>
        <measure>
          <title>Biochemistry Safety Laboratory Parameters: Liver Function Test - Bilirubin Concentration</title>
          <description>Old red blood cells are replaced by new blood cells every day. Bilirubin is made by the body when the old blood cells are removed. The concentration of bilirubin in the blood measures liver function. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.</description>
          <population>The protocol pre-specified that the young and very young children will be reported as one group.&#xD;
(Adolescents-Visit 2 &amp; 3: N=20 - 1 participant with data missing; Older Children-Visit 1 &amp; 2: N=26 thus 2 participants with data missing; Young and Very Young Children-Visits 1 &amp; 3: N=12 (5 with data missing) &amp; at Visit 2 N=9 (8 with data missing).</population>
          <units>µmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.0" spread="7.0"/>
                    <measurement group_id="O2" value="6.8" spread="3.5"/>
                    <measurement group_id="O3" value="4.8" spread="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.9" spread="7.8"/>
                    <measurement group_id="O2" value="6.3" spread="2.3"/>
                    <measurement group_id="O3" value="3.7" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.8" spread="10.8"/>
                    <measurement group_id="O2" value="9.3" spread="4.5"/>
                    <measurement group_id="O3" value="5.8" spread="2.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Biochemistry Safety Laboratory Parameters: Liver Function Test - Lactate Dehydrogenase (LDH) Enzyme Activity</title>
        <description>Lactate Dehydrogenase (LDH) was used to check for tissue damage. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.</description>
        <time_frame>Enrollment Visit, Visit 2 and Discharge Visit</time_frame>
        <population>The protocol pre-specified that the young and very young children will be reported as one group.&#xD;
(Adolescents Group at Visit 3: N=20 one participant with missing data; Older Children at Visits 1 and 3: N=26 and at Visit 2 N=24 participants; Young and Very Young Children Group at Visits 1 and 3: N=16 participant with missing data).</population>
        <group_list>
          <group group_id="O1">
            <title>LDH Activity: Adolescents</title>
            <description>Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
          <group group_id="O2">
            <title>LDH Activity: Older Children</title>
            <description>Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
          <group group_id="O3">
            <title>LDH Activity: Young &amp; Very Young Children</title>
            <description>Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
        </group_list>
        <measure>
          <title>Biochemistry Safety Laboratory Parameters: Liver Function Test - Lactate Dehydrogenase (LDH) Enzyme Activity</title>
          <description>Lactate Dehydrogenase (LDH) was used to check for tissue damage. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.</description>
          <population>The protocol pre-specified that the young and very young children will be reported as one group.&#xD;
(Adolescents Group at Visit 3: N=20 one participant with missing data; Older Children at Visits 1 and 3: N=26 and at Visit 2 N=24 participants; Young and Very Young Children Group at Visits 1 and 3: N=16 participant with missing data).</population>
          <units>U/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="157.7" spread="23.0"/>
                    <measurement group_id="O2" value="210.5" spread="31.7"/>
                    <measurement group_id="O3" value="243.8" spread="23.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="154.5" spread="27.9"/>
                    <measurement group_id="O2" value="199.1" spread="27.2"/>
                    <measurement group_id="O3" value="256.3" spread="36.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="143.9" spread="28.8"/>
                    <measurement group_id="O2" value="197.8" spread="28.5"/>
                    <measurement group_id="O3" value="238.6" spread="24.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Biochemistry Safety Laboratory Parameters: Blood Protein Concentration</title>
        <description>The test was done to verify kidney and liver function. It is done in combination with the albumin test. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.</description>
        <time_frame>Enrollment Visit, Visit 2 and Discharge Visit</time_frame>
        <population>The protocol pre-specified that the young and very young children will be reported as one group.&#xD;
(Adolescents Group at Visit 3: N=20 one participant with missing data; Older Children at Visit 2: N=27 one participant with missing data; Young and Very Young Children Group at Visit 3: N=16 one participant with missing data).</population>
        <group_list>
          <group group_id="O1">
            <title>Protein Concentration: Adolescents</title>
            <description>Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
          <group group_id="O2">
            <title>Protein Concentration: Older Children</title>
            <description>Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
          <group group_id="O3">
            <title>Protein Concentration: Young &amp; Very Young Children</title>
            <description>Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
        </group_list>
        <measure>
          <title>Biochemistry Safety Laboratory Parameters: Blood Protein Concentration</title>
          <description>The test was done to verify kidney and liver function. It is done in combination with the albumin test. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.</description>
          <population>The protocol pre-specified that the young and very young children will be reported as one group.&#xD;
(Adolescents Group at Visit 3: N=20 one participant with missing data; Older Children at Visit 2: N=27 one participant with missing data; Young and Very Young Children Group at Visit 3: N=16 one participant with missing data).</population>
          <units>g/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72.3" spread="3.5"/>
                    <measurement group_id="O2" value="73.3" spread="4.4"/>
                    <measurement group_id="O3" value="68.6" spread="4.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64.2" spread="4.6"/>
                    <measurement group_id="O2" value="61.8" spread="4.4"/>
                    <measurement group_id="O3" value="62.1" spread="4.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64.9" spread="4.4"/>
                    <measurement group_id="O2" value="62.1" spread="5.5"/>
                    <measurement group_id="O3" value="61.8" spread="4.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Biochemistry Safety Laboratory Parameters: Creatine Kinase (CK) Enzyme Activity</title>
        <description>The creatine kinase (CK) test was used to detect inflammation of muscles. The test was done in combination with other tests. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.</description>
        <time_frame>Enrollment Visit, Visit 2 and Discharge Visit</time_frame>
        <population>The protocol pre-specified that the young and very young children will be reported as one group.&#xD;
(Adolescents Group at Visit 3: N=20 one participant with missing data; Older children at Visit 1: N=27 (1 participant missing); Young and Very Young Children Group at Visit 3: N=16 one participant with missing data at this visit).</population>
        <group_list>
          <group group_id="O1">
            <title>CK Activity: Adolescents</title>
            <description>Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
          <group group_id="O2">
            <title>CK Activity: Older Children</title>
            <description>Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
          <group group_id="O3">
            <title>CK Activity: Young &amp; Very Young Children</title>
            <description>Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
        </group_list>
        <measure>
          <title>Biochemistry Safety Laboratory Parameters: Creatine Kinase (CK) Enzyme Activity</title>
          <description>The creatine kinase (CK) test was used to detect inflammation of muscles. The test was done in combination with other tests. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.</description>
          <population>The protocol pre-specified that the young and very young children will be reported as one group.&#xD;
(Adolescents Group at Visit 3: N=20 one participant with missing data; Older children at Visit 1: N=27 (1 participant missing); Young and Very Young Children Group at Visit 3: N=16 one participant with missing data at this visit).</population>
          <units>U/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="126.0" spread="66.0"/>
                    <measurement group_id="O2" value="109.8" spread="31.7"/>
                    <measurement group_id="O3" value="133.4" spread="35.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="186.8" spread="216.2"/>
                    <measurement group_id="O2" value="283.3" spread="158.5"/>
                    <measurement group_id="O3" value="275.8" spread="87.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="264.6" spread="564.4"/>
                    <measurement group_id="O2" value="288.1" spread="214.8"/>
                    <measurement group_id="O3" value="203.6" spread="84.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Biochemistry Safety Laboratory Parameters: Alkaline Phosphatase (ALP) Enzyme Activity</title>
        <description>The Alkaline Phosphatase activity was used to detect bone or hepatobiliary disease. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.</description>
        <time_frame>Enrollment Visit, Visit 2 and Discharge Visit</time_frame>
        <population>The protocol pre-specified that the young and very young children will be reported as one group.&#xD;
(Adolescents Group at Visit 2 and 3: N=20 one participant with missing data; Young and Very Young Children Group at Visits 3: N=16 one participant with missing data at this visit).</population>
        <group_list>
          <group group_id="O1">
            <title>ALP Activity: Adolescents</title>
            <description>Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
          <group group_id="O2">
            <title>ALP Activity: Older Children</title>
            <description>Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
          <group group_id="O3">
            <title>ALP Activity: Young &amp; Very Young Children</title>
            <description>Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
        </group_list>
        <measure>
          <title>Biochemistry Safety Laboratory Parameters: Alkaline Phosphatase (ALP) Enzyme Activity</title>
          <description>The Alkaline Phosphatase activity was used to detect bone or hepatobiliary disease. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.</description>
          <population>The protocol pre-specified that the young and very young children will be reported as one group.&#xD;
(Adolescents Group at Visit 2 and 3: N=20 one participant with missing data; Young and Very Young Children Group at Visits 3: N=16 one participant with missing data at this visit).</population>
          <units>U/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="124.7" spread="62.7"/>
                    <measurement group_id="O2" value="240.0" spread="50.8"/>
                    <measurement group_id="O3" value="230.1" spread="26.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="114.7" spread="53.9"/>
                    <measurement group_id="O2" value="207.5" spread="42.2"/>
                    <measurement group_id="O3" value="210.2" spread="31.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="107.6" spread="54.3"/>
                    <measurement group_id="O2" value="204.1" spread="46.7"/>
                    <measurement group_id="O3" value="199.2" spread="26.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Biochemistry Safety Laboratory Parameters: Triacylglycerol Lipase (TL) Enzyme Activity</title>
        <description>A triacylglycerol lipase test was done to check for pancreatic function. In the study there were 3 planned safety blood draws for routine blood tests. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to investigational medicinal product administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.</description>
        <time_frame>Enrollment Visit, Visit 2 and Discharge Visit</time_frame>
        <population>The protocol pre-specified that the young and very young children will be reported as one group.&#xD;
(Adolescents Group at Visit 3: N=20 one participant with missing data; Older Children N=27 at Visit 1 one participant with missing data; Young and Very Young Children Group at Visit 3: N=16 one participant with missing data at visit).</population>
        <group_list>
          <group group_id="O1">
            <title>TL Activity: Adolescents</title>
            <description>Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
          <group group_id="O2">
            <title>TL Activity: Older Children</title>
            <description>Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
          <group group_id="O3">
            <title>TL Activity: Young &amp; Very Young Children</title>
            <description>Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
          </group>
        </group_list>
        <measure>
          <title>Biochemistry Safety Laboratory Parameters: Triacylglycerol Lipase (TL) Enzyme Activity</title>
          <description>A triacylglycerol lipase test was done to check for pancreatic function. In the study there were 3 planned safety blood draws for routine blood tests. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to investigational medicinal product administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.</description>
          <population>The protocol pre-specified that the young and very young children will be reported as one group.&#xD;
(Adolescents Group at Visit 3: N=20 one participant with missing data; Older Children N=27 at Visit 1 one participant with missing data; Young and Very Young Children Group at Visit 3: N=16 one participant with missing data at visit).</population>
          <units>U/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.5" spread="10.5"/>
                    <measurement group_id="O2" value="30.3" spread="9.4"/>
                    <measurement group_id="O3" value="26.3" spread="8.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.7" spread="8.3"/>
                    <measurement group_id="O2" value="22.6" spread="8.8"/>
                    <measurement group_id="O3" value="19.6" spread="6.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.8" spread="18.3"/>
                    <measurement group_id="O2" value="22.2" spread="9.2"/>
                    <measurement group_id="O3" value="19.3" spread="6.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Any adverse event that started on the intake of tapentadol up to 48 hours thereafter.</time_frame>
      <desc>For tapentadol oral solution, the therapeutic reach is defined as 48 hours after intake.&#xD;
The age groups reported were prespecified in the protocol.</desc>
      <group_list>
        <group group_id="E1">
          <title>Adolescents</title>
          <description>Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
        </group>
        <group group_id="E2">
          <title>Older Children</title>
          <description>Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
        </group>
        <group group_id="E3">
          <title>Young and Very Young Children</title>
          <description>Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 16.1</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>post-procedural hemorrhage</sub_title>
                <description>Post-procedural hemorrhage occurred 6 days following tonsillectomy. Outside the therapeutic range of the investigational product.</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>3.6</frequency_threshold>
        <default_vocab>MedDRA 16.1</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Diplopia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Enlarged uvula</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Infusion site irritation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Vessel puncture site bruise</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Otitis media</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Otitis media viral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Cardiac murmur</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Blood creatine phosphokinase increased</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Nasal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hot flush</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The sponsor reserves the right to review any publication pertaining to the trial before it is submitted for publication. Neither party has the right to prohibit publication unless publication can be shown to affect possible patent rights.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Another opioid may been given according to medical judgment/standard of care if the participant had persistent intolerable pain 2 hours or more after administration of tapentadol oral solution despite having received a non-opioid analgesic.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Director of Clinical Trials</name_or_title>
      <organization>Grünenthal GmbH</organization>
      <phone>+49 241 569 3223</phone>
      <email>Clinical-Trials@grunenthal.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01729728
org study id: KF5503/68
secondary id: 2013-002016-27
nct id: NCT01729728
lead sponsor: 
collaborator: 
To find out if a drug called tapentadol administered by mouth safely relieves pain in
      children. Look at the amount of tapentadol in the blood after a single oral dose.

      Tapentadol oral solution for children is still being tested and is not yet registered.
      Tapentadol tablets are effective in treating both acute and chronic pain in adults. This
      trial will help to understand how tapentadol oral solution works in children.
The lower age limit for the clinical trial was initially set to 3 years of age in the
      protocol. The trial planned for the inclusion of participants in three age categories. Age 3
      to less than 6 years (young children), age 6 to less than 12 years (older children) and age
      12 to less than 18 years of age (adolescents). There was a request by the Paediatric
      Committee (PDCO) at the European Medicines Agency to include participants 2 years of age
      (very young children). The protocol amendment thus planned to combine the two youngest age
      groups into a single reporting group. The protocol amendment only planned that the very young
      children group would have separate analysis for the Faces Pain Scale Revised (FPS-R) Scale
      and for the presentation of the serum concentrations, because the pharmacokinetic sampling
      scheme used in the 2 year old participants was different from the young children group (aged
      3 to less than 6 years).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Pharmacokinetic Profile of Serum Concentrations of Tapentadol After a Single Dose of Tapentadol Oral Solution in Adolescents (Age 12 to Less Than 18 Years).
time frame: up to 15 hours
description: Mean and Standard Deviation of Serum Concentrations of Tapentadol. Serum was analyzed by means of liquid chromatography coupled to tandem mass spectrometry with a lower limit of quantification (LLOQ) at 0.2 ng/mL.
measure: Pharmacokinetic Profile of Serum Concentrations of Tapentadol-O-glucuronide After a Single Dose of Tapentadol Oral Solution in Adolescents (Age 12 to Less Than 18 Years).
time frame: up to 15 hours
description: Mean and Standard Deviation of Serum Concentrations of Tapentadol-O-glucuronide. Tapentadol-O-glucuronide is the metabolite of tapentadol. Metabolites are sometimes referred to as "breakdown products". The body alters the administered medication to a metabolite so that it can be more easily or quickly removed from the body. Tapentadol-O-glucuronide concentrations were measured in participants. Serum was analyzed by means of liquid chromatography coupled to tandem mass spectrometry with a lower limit of quantification (LLOQ) at 10 ng/mL.
measure: Pharmacokinetic Profile of Serum Concentrations of Tapentadol After a Single Dose of Tapentadol Oral Solution in Older Children (Age 6 to Less Than 12 Years).
time frame: up to 15 hours
description: Mean and Standard Deviation of Serum Concentrations of Tapentadol. Serum was analyzed by means of liquid chromatography coupled to tandem mass spectrometry with a lower limit of quantification (LLOQ) at 0.2 ng/mL.
measure: Pharmacokinetic Profile of Serum Concentrations of Tapentadol-O-glucuronide After a Single Dose of Tapentadol Oral Solution in Older Children (Age 6 to Less Than 12 Years).
time frame: up to 15 hours
description: Mean and Standard Deviation of Serum Concentrations of Tapentadol-O-glucuronide. Tapentadol-O-glucuronide is the metabolite of tapentadol. Metabolites are sometimes referred to as "breakdown products". The body alters the administered medication to a metabolite so that it can be more easily or quickly removed from the body. Tapentadol-O-glucuronide concentrations were measured in participants. Serum was analyzed by means of liquid chromatography coupled to tandem mass spectrometry with a lower limit of quantification (LLOQ) at 10 ng/mL.
measure: Pharmacokinetic Profile of Serum Concentrations of Tapentadol After a Single Dose of Tapentadol Oral Solution in Younger Children (Age 3 to Less Than 6 Years).
time frame: up to 15 hours
description: Mean and Standard Deviation of Serum Concentrations of Tapentadol. Serum was analyzed by means of liquid chromatography coupled to tandem mass spectrometry with a lower limit of quantification (LLOQ) at 0.2 ng/mL.
measure: Pharmacokinetic Profile of Serum Concentrations of Tapentadol-O-glucuronide After a Single Dose of Tapentadol Oral Solution in Younger Children (Age 3 to Less Than 6 Years).
time frame: up to 15 hours
description: Mean and Standard Deviation of Serum Concentrations of Tapentadol-O-glucuronide. Tapentadol-O-glucuronide is the metabolite of tapentadol. Metabolites are sometimes referred to as "breakdown products". The body alters the administered medication to a metabolite so that it can be more easily or quickly removed from the body. Tapentadol-O-glucuronide concentrations were measured in participants. Serum was analyzed by means of liquid chromatography coupled to tandem mass spectrometry with a lower limit of quantification (LLOQ) at 10 ng/mL.
measure: Pharmacokinetic Profile of Serum Concentrations of Tapentadol After a Single Dose of Tapentadol Oral Solution in Very Young Children (Age 2 to Less Than 3 Years).
time frame: up to 15 hours
description: Mean and Standard Deviation of Serum Concentrations of Tapentadol. Serum was analyzed by means of liquid chromatography coupled to tandem mass spectrometry with a lower limit of quantification (LLOQ) at 0.2 ng/mL.
measure: Pharmacokinetic Profile of Serum Concentrations of Tapentadol-O-glucuronide After a Single Dose of Tapentadol Oral Solution in Very Young Children (Age 2 to Less Than 3 Years).
time frame: up to 15 hours
description: Mean and Standard Deviation of Serum Concentrations of Tapentadol-O-glucuronide. Tapentadol-O-glucuronide is the metabolite of tapentadol. Metabolites are sometimes referred to as "breakdown products". The body alters the administered medication to a metabolite so that it can be more easily or quickly removed from the body. Tapentadol-O-glucuronide concentrations were measured in participants. Serum was analyzed by means of liquid chromatography coupled to tandem mass spectrometry with a lower limit of quantification (LLOQ) at 10 ng/mL.
measure: Non-Compartmental Pharmacokinetic (PK) Parameter of Tapentadol Area Under the Concentration-Time Curve (AUC 0-15) After a Single Dose of Tapentadol in Adolescent Participants (Age 12 to Less Than 18 Years).
time frame: up to 15 hours
description: Serum samples for pharmacokinetic analysis were obtained using frequent sampling techniques in participants 12 years to less than 18 years of age.
Serum samples (frequent sampling) were drawn at 0.25, 0.5, 1, 2, 4, 6, 11, and 15 hours.
The Area Under the Curve (AUC) from dose to 15 hours (AUC 0-15) is a summary measure of data from each pharmacokinetic blood sample taken over the 15 hour time period.
The area is that below the line fitted to the data points.
measure: Non-Compartmental Pharmacokinetic (PK) Parameter: Cmax (Maximum Concentration) of Tapentadol After a Single Dose of Tapentadol in Adolescents (Age 12 to Less Than 18 Years).
time frame: up to 15 hours
description: Serum samples for pharmacokinetic analysis were obtained using frequent sampling techniques in participants 12 years to less than 18 years of age.
Serum samples (frequent sampling) were drawn at 0.25, 0.5, 1, 2, 4, 6, 11, and 15 hours. The concentration of tapentadol (active drug) is assessed during absorption and distribution.
The maximum concentration is derived from the Area Under the Curve, from dose to 15 hours (AUC 0-15). It is the highest amount of active drug observed in the blood sample
measure: Non-Compartmental Pharmacokinetic (PK) Parameter: Time to Maximum Concentration (Tmax) of Tapentadol After a Single Dose of Tapentadol in Adolescents (Age 12 to Less Than 18 Years).
time frame: up to 15 hours
description: Serum samples for pharmacokinetic analysis were obtained using frequent sampling techniques in participants 12 years to less than 18 years of age.
The time to maximum concentration is derived from the area under the curve from dose to 15 hours (AUC 0-15). The Tmax is the time after dosing at which the maximum concentration of the tapentadol (active drug) occurs.
Serum samples (frequent sampling) were drawn at 0.25, 0.5, 1, 2, 4, 6, 11, and 15 hours.
measure: Non-Compartmental Pharmacokinetic (PK) Parameter of Tapentadol-O-glucuronide Area Under the Concentration-Time Curve (AUC 0-15) After a Single Dose of Tapentadol in Adolescents (Age 12 to Less Than 18 Years).
time frame: up to 15 hours
description: Serum samples for pharmacokinetic analysis were obtained using frequent sampling techniques in participants 12 years to less than 18 years of age.
Serum samples (frequent sampling) were drawn at 0.25, 0.5, 1, 2, 4, 6, 11, and 15 hours. The concentration of tapentadol (active drug) is assessed during absorption and distribution.
The maximum concentration is derived from the Area Under the Curve, from dose to 15 hours (AUC 0-15). It is the highest amount of active drug observed in the blood sample.
measure: Non-Compartmental Pharmacokinetic (PK) Parameter: Cmax (Maximum Concentration) of Tapentadol-O-glucuronide After a Single Dose of Tapentadol in Adolescents (Age 12 to Less Than 18 Years).
time frame: up to 15 hours
description: Tapentadol-O-glucuronide is the metabolite of tapentadol. Metabolites are sometimes referred to as "breakdown products". The body alters the administered medication to a metabolite so that it can be more easily or quickly removed from the body. Serum samples (frequent sampling) were drawn at 0.25, 0.5, 1, 2, 4, 6, 11, and 15 hours. The concentration of tapentadol-O-glucuronide (metabolite) is assessed to study absorption and distribution.
The maximum concentration is derived from the Area Under the Curve, from dose to 15 hours (AUC 0-15). It is the highest amount of metabolite observed in the blood sample.
measure: Non-Compartmental Pharmacokinetic (PK) Parameter: Time to Maximum Concentration (Tmax) of Tapentadol-O-glucuronide After a Single Dose of Tapentadol in Adolescents (Age 12 to Less Than 18).
time frame: up to 15 hours
description: Tapentadol-O-glucuronide is the metabolite of tapentadol. Metabolites are sometimes referred to as "breakdown products". The body alters the administered medication to a metabolite so that it can be more easily or quickly removed from the body. Serum samples for pharmacokinetic analysis were obtained using frequent sampling techniques in participants 12 years to less than 18 years of age. The time to maximum concentration is derived from the area under the curve from dose to 15 hours (AUC 0-15). The Tmax is the time after dosing at which the maximum concentration of the tapentadol-O-glucuronide (metabolite) occurs. Serum samples (frequent sampling) were drawn at 0.25, 0.5, 1, 2, 4, 6, 11, and 15 hours.
measure: Pain Intensity Assessments Using the Visual Analog Scale (VAS) in Adolescents (Age 12 to Less Than 18 Years).
time frame: Baseline; 15 hours
description: At predefined times after investigational medicinal product administration, participants were asked to rate their pain on a 100 mm line (visual analog scale - VAS) by marking a point on the line in response to:
"My pain at this time is". The mark was scored between "no pain" and " pain as bad as it could be". The distance was then measured by a clinician and reported.
A value of 0 indicates "no pain". A value of 100 indicates "pain as bad as it could be".
measure: Pain Intensity Assessments Using the McGrath Color Analog Scale in Adolescent Participants and Older Children (Age 6 to Less Than 18 Years).
time frame: Baseline; 15 hours post-dose
description: Pain intensity assessments were with a 0 (no pain) to 10 (worst pain) scored McGrath color analog scale (CAS) in participants aged 6 years to less than 18 years, i.e. in Adolescents and Older Children. Participants were presented with the CAS and instructed to place the sliding bar on the color that best represented their pain intensity level at the time of assessment. The CAS is a pocket size tool used to measure the self-reported pain intensity of the older participants. The CAS consists of a 145 mm long triangular shaped strip of plastic, varying in width and hue from 1 mm wide and light pink hue at the bottom (and text no pain), to 3 mm wide and deep red hue at the top (most pain). This instrument includes 2 sides. One side shows the color pain intensity scale as described and the other shows a graduated scale, which provides a specific numeric value for the participant-reported level of pain.
measure: Pain Intensity Assessments Using the Faces Pain Scale (Revised) in Children Age 3 to Less Than 12 Years.
time frame: Baseline; 15 hours post-dose
description: This assessment tool was used in 3 to less than 12 year old participants, i.e. Older Children and Young Children.
The Faces Pain Scale (Revised) [FPS-R] score as allocated to a selected face by the participant. There are 6 faces and the participant is asked to indicate on a face to express how much it hurts.
The numeric value 0 (no pain) to 10 (very much pain) is read off the reverse side of the scale by the clinician.
measure: Pain Intensity Assessment Using the Face, Legs, Activity, Cry, Consolability Scale in Young and Very Young Children (Age 2 to Less Than 6 Years).
time frame: Baseline; 15 hours post-dose
description: The Face Legs Activity Cry Consolability (FLACC) Scale was developed by the Department of Anesthesiology, University of Michigan Medical School and Health Systems. The FLACC Scale is a behavioral scale for scoring postoperative pain in children between the ages of two months and seven years or in persons unable to communicate. In this trial the scale was used in the young and very young children, i.e. in participants aged 2 to less than 6 years. This tool includes five categories of pain behaviors, including facial expression, leg movement, activity, cry, and consolability. The clinician observes the participant for 5 minutes or more and scores each category with a 0, 1 or 2. The scores are added together for a total score ranging from 0 (no pain) to 10 (worst pain). The higher the total score the higher the pain.
measure: Sum of Pain Intensity Differences Over the 4 Hours After Dosing Derived From the Different Pain Scales and for All Age Groups
time frame: Baseline; 4 hours post-dose
description: Different pain intensity assessment tools were used in the different age groups. Therefore the sum of pain intensities were calculated and are reported for each age group based on the tool used.
Adolescents - Age 12 to Less Than 18 Years.
Older Children - Age 6 to Less Than 12 Years.
Young Children - Age 3 to Less Than 6 Years.
Very Young Children - Age 2 to Less Than 3 Years.
CAS (McGrath color analog scale) [Theoretical Range: -40 to + 40],
VAS (100 mm Visual Analog Scale) [Theoretical Range: -400 to + 400],
FPS-R (6-point Faces Pain Scale - Revised) [Theoretical Range: -40 to + 40],
FLACC (Face, Legs, Activity, Cry, and Consolability score) [Theoretical Range: -40 to + 40].
A mean score of zero indicates that there was no pain intensity change over the 4 hours.
The positive values indicate that in the group as a whole the sum of all pain intensity values over the first 4 hours lead to a reduction in pain in the time period.
measure: Respiratory Rate Assessments
time frame: Enrollment Visit; 15 hours post-dose
description: Respiratory rate assessments were performed at pre-defined times during the 15 hour period following investigational medicinal product intake.
Pre-surgery data for these participants is also given from the enrollment Visit (Visit 1).
measure: Oxygen Saturation Assessments
time frame: Enrollment Visit; 15 hours post-dose
description: Oxygen saturation assessments were performed at pre-defined times during the 15 hour period following investigational medicinal product intake.
Oxygen saturation was assessed using pulse oximetry. The uppermost value is 100%.
Pre-surgery data for these participants is also given from the enrollment Visit (Visit 1).
measure: Systolic and Diastolic Blood Pressure Assessments
time frame: Enrollment Visit; 15 hours post-dose
description: Systolic and Diastolic blood pressure assessments were performed at pre-defined times during the 15 hour period following investigational medicinal product intake.
Pre-surgery data for these participants is also given from the enrollment Visit (Visit 1).
measure: Change From Enrollment in 12-lead Electrocardiogram Parameters
time frame: Enrollment (pre-surgery); Discharge Visit
description: 12-lead electrocardiograms (ECG) were part of the planned safety assessments. 12-lead Electrocardiograms were performed prior at the enrollment visit after informed consent and at the discharge visit. The discharge visit was as per standard of care.
The changes in ECG parameters are reported. Negative mean values indicate that the millisecond intervals decreased from the enrollment to the discharge visit. Positive mean values indicate that the millisecond intervals increased from the enrollment to the discharge visit. The Letters P,Q,R,S and T refer to specific medically defined points on an ECG tracing and correspond to specific heart activities.
measure: Change From Enrollment in 12-lead Electrocardiogram Heart Rate Parameter
time frame: Enrollment; Discharge Visit
description: 12-lead Electrocardiograms (ECG) were part of the planned safety assessments. 12-lead Electrocardiograms were performed prior at the enrollment visit after informed consent and at the discharge visit. The discharge visit was as per standard of care.
The changes in heart rate (beats per minute) parameters are reported per treatment group between the visits.
A positive value indicates that the heart rate was higher at discharge than at enrollment.
measure: Treatment Emergent Adverse Events by Intensity
time frame: Baseline; 48 hours post dosing
description: The intensity of all treatment emergent adverse events (TEAEs) were scored by the investigator. Treatment emergent adverse events were those adverse events documented from the time of investigational medicinal product (IMP), study drug, up to 48 hours post dosing.
The clinical "intensity" of an adverse event was classified as:
Mild: Signs and symptoms that can be easily tolerated. Symptoms can be ignored and disappear when the subject is distracted.
Moderate: Symptoms cause discomfort but are tolerable; they cannot be ignored and affect concentration.
Severe: Symptoms which affect usual daily activity.
For adverse events where the intensity changes over time, the maximum intensity observed was documented.
measure: Intake of Additional Analgesic Medication During the Trial
time frame: Baseline; 15 hours post dosing
description: Number of participants with intakes of supplemental analgesic medication between investigational medicinal product (IMP) intake and Site Discharge grouped according to preparation taken (non-opioid/opioid).
measure: Hematology Safety Laboratory Assessments: Hemoglobin Concentration
time frame: Enrollment Visit; Visit 2 and Discharge Visit
description: The hemoglobin test is a commonly ordered blood test and was done as part of a complete blood count (CBC). It is routinely done before and after surgery to check for anemia, the presence of chronic kidney disease or other chronic medical problems. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.
measure: Hematology Safety Laboratory Assessments: Hematocrit
time frame: Enrollment Visit; Visit 2 and Discharge Visit
description: Hematocrit is a blood test that measures the percentage of the volume of whole blood that is made up of red blood cells (RBC). This measurement depends on the number of red blood cells and the size of red blood cells. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.
measure: Hematology Safety Laboratory Assessments: Erythrocyte Mean Corpuscular Volume (Mean Corpuscular Volume)
time frame: Enrollment Visit; Visit 2 and Discharge Visit
description: Erythrocyte Mean Corpuscular volume is a measurement of the average size of Red Blood Cells (RBC). It is also referred to as Mean Corpuscular Volume. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.
measure: Hematology Safety Laboratory Assessments: Platelet Count
time frame: Enrollment Visit; Visit 2 and Discharge Visit
description: Platelets are cell fragments that are vital for normal blood clotting. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.
measure: Hematology Safety Laboratory Assessments: Leukocyte Concentration
time frame: Enrollment Visit; Visit 2 and Discharge Visit
description: Leukocytes are also called white blood cells (WBC). These were measured to assess immune function. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.
measure: Biochemistry Safety Laboratory Parameters: Blood Glucose Concentration
time frame: Enrollment Visit; Visit 2 and Discharge Visit
description: A blood glucose test measures the amount of a sugar called glucose in blood. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.
measure: Biochemistry Safety Laboratory Parameters: Blood Sodium Concentration
time frame: Enrollment Visit; Visit 2 and Discharge Visit
description: Sodium is required by the body for the body to function properly. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.
measure: Biochemistry Safety Laboratory Parameters: Blood Potassium Concentration
time frame: Enrollment Visit; Visit 2 and Discharge Visit
description: Potassium is a mineral that the body needs to work normally. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.
measure: Biochemistry Safety Laboratory Parameters: Blood Calcium Concentration
time frame: Enrollment Visit; Visit 2 and Discharge Visit
description: All cells need calcium in order to function. In the study there were 3 planned safety blood draws for routine blood tests. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.
measure: Biochemistry Safety Laboratory Parameters: Blood Chloride Concentration
time frame: Enrollment Visit; Visit 2 and Discharge Visit
description: Chloride with other electrolytes help keep the proper balance of body fluids and maintain the body's acid-base balance. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care
measure: Biochemistry Safety Laboratory Parameters: Blood Phosphate Concentration
time frame: Enrollment Visit; Visit 2 and Discharge Visit
description: Phosphate is needed by the body. This test was done to see how much phosphate is in the blood. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.
measure: Biochemistry Safety Laboratory Parameters: Blood Urea Nitrogen (BUN) Concentration
time frame: Enrollment Visit; Visit 2 and Discharge Visit
description: This test is to measure the amount of urea nitrogen in the blood. It was used to test liver and kidney function. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.
measure: Biochemistry Safety Laboratory Parameters: Creatinine Concentration
time frame: Enrollment Visit; Visit 2 and Discharge Visit
description: Creatinine is removed from the body entirely by the kidneys. If kidney function is not normal, creatinine level increases in the blood. In the study there were 3 planned safety blood draws for routine blood tests. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.
measure: Biochemistry Safety Laboratory Parameters: Aspartate Aminotransferase (AST) Enzyme Activity
time frame: Enrollment Visit; Visit 2 and Discharge Visit
description: AST is considered to be one of the two most important tests to detect liver injury. During liver damage the enzyme is released into the blood. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.
measure: Biochemistry Safety Laboratory Parameters: Triglycerides Concentration
time frame: Enrollment Visit; Visit 2 and Discharge Visit
description: Triglycerides are a group of fat. Triglycerides were measured as part of metabolic and cardiac assessments. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.
measure: Biochemistry Safety Laboratory Parameters: Serum Albumin Concentration
time frame: Enrollment Visit; Visit 2 and Discharge Visit
description: Albumin is a protein made by the liver. Albumin prevents fluid leaking into the tissues. Albumin also transports many small molecules. Serum albumin was measured in the clear liquid portion of the blood called serum. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.
measure: Biochemistry Safety Laboratory Parameters: Urate in the Blood
time frame: Enrollment Visit; Visit 2 and Discharge Visit
description: Uric acid (urate is the salt) is a chemical created when the body breaks down substances called purines. Most urate dissolves in blood and travels to the kidneys. From there, it passes out in the urine. The test is used to determine kidney function. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.
measure: Biochemistry Safety Laboratory Parameters: Calculated Glomerular Filtration Rate
time frame: Enrollment Visit; Visit 2 and Discharge Visit
description: Glomerular filtration rate (GFR) was done to check how well the kidneys are working. It estimates how much blood passes through the glomeruli in the kidney each minute. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.
measure: Biochemistry Safety Laboratory Parameters: Urine Specific Gravity
time frame: Enrollment Visit and Discharge Visit
description: This test was used to test for the water balance and urine concentration. A urine sample was tested right away. A dipstick with a color-sensitive pad was used. The color the dipstick changes and the specific gravity of the urine was read off the color chart. In the study there were 2 planned safety urine collections. At Visit 1 in the enrollment period, after consent and assent obtained. The second sample was obtained at Visit 3 prior to discharge from the hospital. The discharge visit was as per standard of care.
measure: Biochemistry Safety Laboratory Parameters: Urine pH (Acid, Alkalinity) Test
time frame: Enrollment Visit and Discharge Visit
description: A urine sample was tested right away. A dipstick made with a color-sensitive pad was used. The color indicated the acidity of the urine. In the study there were 2 planned safety urine collections. At Visit 1 in the enrollment period, after consent and assent obtained. The second sample was obtained at Visit 3 prior to discharge from the hospital. The discharge visit was as per standard of care.
measure: Biochemistry Safety Laboratory Parameters: Liver Function Test - Alanine Aminotransferase (ALT) Enzyme Activity
time frame: Enrollment Visit, Visit 2 and Discharge Visit
description: This test was done in combination with other tests (such as AST, ALP, and bilirubin) to diagnose and monitor the liver function. In the study there were 3 planned safety blood draws for routine blood tests. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.
measure: Biochemistry Safety Laboratory Parameters: Liver Function Test - Gamma-Glutamyl Transferase (GGT) Enzyme Activity
time frame: Enrollment Visit, Visit 2 and Discharge Visit
description: The gamma-glutamyl transferase (GGT) test was used in combination with the alkaline phosphatase (ALP) test. Both ALP and GGT can be elevated in bile duct or liver complications. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.
measure: Biochemistry Safety Laboratory Parameters: Liver Function Test - Bilirubin Concentration
time frame: Enrollment Visit, Visit 2 and Discharge Visit
description: Old red blood cells are replaced by new blood cells every day. Bilirubin is made by the body when the old blood cells are removed. The concentration of bilirubin in the blood measures liver function. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.
measure: Biochemistry Safety Laboratory Parameters: Liver Function Test - Lactate Dehydrogenase (LDH) Enzyme Activity
time frame: Enrollment Visit, Visit 2 and Discharge Visit
description: Lactate Dehydrogenase (LDH) was used to check for tissue damage. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.
measure: Biochemistry Safety Laboratory Parameters: Blood Protein Concentration
time frame: Enrollment Visit, Visit 2 and Discharge Visit
description: The test was done to verify kidney and liver function. It is done in combination with the albumin test. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.
measure: Biochemistry Safety Laboratory Parameters: Creatine Kinase (CK) Enzyme Activity
time frame: Enrollment Visit, Visit 2 and Discharge Visit
description: The creatine kinase (CK) test was used to detect inflammation of muscles. The test was done in combination with other tests. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.
measure: Biochemistry Safety Laboratory Parameters: Alkaline Phosphatase (ALP) Enzyme Activity
time frame: Enrollment Visit, Visit 2 and Discharge Visit
description: The Alkaline Phosphatase activity was used to detect bone or hepatobiliary disease. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.
measure: Biochemistry Safety Laboratory Parameters: Triacylglycerol Lipase (TL) Enzyme Activity
time frame: Enrollment Visit, Visit 2 and Discharge Visit
description: A triacylglycerol lipase test was done to check for pancreatic function. In the study there were 3 planned safety blood draws for routine blood tests. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to investigational medicinal product administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.
arm group label: Tapentadol
arm group type: Experimental
intervention type: Drug
intervention name: Tapentadol
description: Tapentadol oral solution single dose (1mg/kg body weight)
arm group label: Tapentadol
criteria: 
gender: All
minimum age: 2 Years
maximum age: 17 Years
healthy volunteers: No
last name: Study Director
role: Study Director
affiliation: Grünenthal GmbH
facility: 
country: United States
citation: Muse D, Tarau E, Lefeber C, Sohns M, Brett M, Goldberg J, Rosenburg R. Pharmacokinetics, safety, and efficacy of tapentadol oral solution for treating moderate to severe pain in pediatric patients. J Pain Res. 2019 May 31;12:1777-1790. doi: 10.2147/JPR.S197039. eCollection 2019.
PMID: 31213888
responsible party type: Sponsor
mesh term: Pain, Postoperative
mesh term: Acute Pain
mesh term: Tapentadol
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Another opioid may been given according to medical judgment/standard of care if the participant had persistent intolerable pain 2 hours or more after administration of tapentadol oral solution despite having received a non-opioid analgesic.
point of contact: 