<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/NCT02184273</url>
  </required_header>
  <id_info>
    <org_study_id>1093.18</org_study_id>
    <nct_id>NCT02184273</nct_id>
  </id_info>
  <brief_title>Efficacy and Tolerability of Nolotil i.v. vs. Placebo i.v. in the Prevention of Postoperative Pain in Children Undergoing Minor Surgery</brief_title>
  <official_title>Randomized, Double Blind, Comparative Trial of the Efficacy and Tolerability of Nolotil i.v. vs. Placebo i.v. in the Prevention of Postoperative Pain in Children of 6 and 11 Years Old Undergoing Minor Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      Study to assess the analgesic efficacy in the prevention of postoperative pain in children&#xD;
      undergoing minor surgery (herniorraphy, tonsillectomy) and to assess the tolerability of&#xD;
      Metamizol in this group of patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2002</start_date>
  <primary_completion_date type="Actual">March 2004</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of children requiring rescue medication</measure>
    <time_frame>up to 4 hours after drug administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time from drug administration, end of surgery and first patient's awake to the administration of rescue medication</measure>
    <time_frame>up to 4 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of children who require rescue medication</measure>
    <time_frame>up to 2 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the pain intensity by the patient by means of a Visual Analogue Scale (VAS)</measure>
    <time_frame>up to 4 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the pain intensity by the patient by means of a four points Verbal Rating Scale (VRS)</measure>
    <time_frame>up to 4 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of the state of the patient by the guardian by means of the Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) test</measure>
    <time_frame>up to 4 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of the partial efficacy by the investigator by means of a four points VRS</measure>
    <time_frame>up to 4 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of the total efficacy by the investigator by means of a four points VRS</measure>
    <time_frame>after 4 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events (AE)</measure>
    <time_frame>up to 4 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of withdrawals due to AEs</measure>
    <time_frame>up to 4 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of the total tolerability of the assigned treatment by the investigator by means of a four points VRS</measure>
    <time_frame>after 4 hours</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">122</enrollment>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Magnesium metamizol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Magnesium metamizol</intervention_name>
    <arm_group_label>Magnesium metamizol</arm_group_label>
    <other_name>Nolotil</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children of either sex between 6 and 11 years of age&#xD;
&#xD;
          -  Patients undergoing routine inguinal hernia repair or tonsillectomy&#xD;
&#xD;
          -  Written informed consents by the guardian, according to the guidelines of Good&#xD;
             Clinical Practice and current legislation&#xD;
&#xD;
          -  The ability of the patient to understand and carry out the visual analogue scale&#xD;
             assessments&#xD;
&#xD;
          -  Patients with a physical status American Society of Anesthesiologist I or II class&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The use of any drug with analgesic properties in the 24 hours prior to the&#xD;
             administration of the study drug&#xD;
&#xD;
          -  Surgery with a foreseen duration over 60 minutes&#xD;
&#xD;
          -  Patients with a nutritional index of less than 90 or greater than 120&#xD;
&#xD;
          -  Patients with a body mass index which was not between the 3rd centile and the 97th&#xD;
             centile for age&#xD;
&#xD;
          -  Patients with any illness or malformation (except hernia) which, in the doctor's&#xD;
             opinion, contraindicated the use of metamizol (aplastic anemia, agranulocytosis of a&#xD;
             toxicological etiology, severe renal disease, etc.)&#xD;
&#xD;
          -  Patients who have received in the previous 7 days or need currently anticoagulant&#xD;
             treatment&#xD;
&#xD;
          -  Significant allergy or known hypersensitivity to metamizol, its excipients and/or to&#xD;
             other nonsteroidal antiinflammatory drugs&#xD;
&#xD;
          -  Patients in whom the anesthetic regimen required by the protocol cannot be used&#xD;
&#xD;
          -  Patients who have participated in another clinical trial in the past four weeks or are&#xD;
             currently participating in another clinical trial&#xD;
&#xD;
          -  Patients with any psychological disturbance which, in the investigator's opinion makes&#xD;
             the patient unsuitable for inclusion in the trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>11 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <link>
    <url>http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1093/1093.18_U05-1666.pdf</url>
    <description>Related Info</description>
  </link>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 8, 2014</study_first_submitted>
  <study_first_submitted_qc>July 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</study_first_posted>
  <last_update_submitted>July 9, 2014</last_update_submitted>
  <last_update_submitted_qc>July 9, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 10, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dipyrone</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02184273
org study id: 1093.18
nct id: NCT02184273
lead sponsor: 
Study to assess the analgesic efficacy in the prevention of postoperative pain in children
      undergoing minor surgery (herniorraphy, tonsillectomy) and to assess the tolerability of
      Metamizol in this group of patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double
measure: Percentage of children requiring rescue medication
time frame: up to 4 hours after drug administration
measure: Time from drug administration, end of surgery and first patient's awake to the administration of rescue medication
time frame: up to 4 hours
measure: Percentage of children who require rescue medication
time frame: up to 2 hours after drug administration
measure: Evaluation of the pain intensity by the patient by means of a Visual Analogue Scale (VAS)
time frame: up to 4 hours
measure: Evaluation of the pain intensity by the patient by means of a four points Verbal Rating Scale (VRS)
time frame: up to 4 hours
measure: Assessment of the state of the patient by the guardian by means of the Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) test
time frame: up to 4 hours
measure: Assessment of the partial efficacy by the investigator by means of a four points VRS
time frame: up to 4 hours
measure: Assessment of the total efficacy by the investigator by means of a four points VRS
time frame: after 4 hours
measure: Number of patients with adverse events (AE)
time frame: up to 4 hours
measure: Number of withdrawals due to AEs
time frame: up to 4 hours
measure: Assessment of the total tolerability of the assigned treatment by the investigator by means of a four points VRS
time frame: after 4 hours
arm group label: Magnesium metamizol
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Magnesium metamizol
arm group label: Magnesium metamizol
other name: Nolotil
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 6 Years
maximum age: 11 Years
healthy volunteers: No
url: http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1093/1093.18_U05-1666.pdf
description: Related Info
responsible party type: Sponsor
mesh term: Pain, Postoperative
mesh term: Dipyrone