<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/NCT04476069</url>
  </required_header>
  <id_info>
    <org_study_id>H-01-R059</org_study_id>
    <nct_id>NCT04476069</nct_id>
  </id_info>
  <brief_title>Ibuprofen as a Pain Management in Pediatric Dentistry</brief_title>
  <official_title>Effect of Preoperative Administration of Ibuprofen in Children Undergoing Extraction for Reducing Postoperative Pain: A Double-blind Randomized Controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Princess Nourah Bint Abdulrahman University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Princess Nourah Bint Abdulrahman University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Abstract Introduction: Administration of non-steroidal anti-inflammatory drugs (NSAIDs)&#xD;
      before tooth extraction may reduce post-surgical pain, but there is a lack of research.&#xD;
&#xD;
      Aims: To compare pain and anxiety in pediatric tooth extraction patients receiving a&#xD;
      preoperative NSAID vs. placebo.&#xD;
&#xD;
      Design: Randomized, double-blind, placebo-controlled clinical trial. Setting: Princess Nourah&#xD;
      Bint Abdulrahman University's (PNU's) dental clinic in Riyadh, Saudi Arabia.&#xD;
&#xD;
      Materials and Methods: Eligible pediatric tooth extraction patients were randomized to Group&#xD;
      A, which received NSAID preoperatively, or Group B, which received placebo.&#xD;
&#xD;
      Interventions: A research coordinator (RC) measured participants prior to extraction, and 3-&#xD;
      and 24-hours post-extraction.&#xD;
&#xD;
      Main Outcome Methods: The Wong-Baker FACES scale (WBFS) and the Modified Child Dental Anxiety&#xD;
      Scale - Faces (MCDASf).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aims The aim of this study was to compare the post-operative pain and anxiety experience of&#xD;
      pediatric tooth extraction patients who receive a preoperative NSAID with those who receive a&#xD;
      placebo in order to evaluate the impact of preoperative NSAID administration on post-surgical&#xD;
      pain and anxiety.&#xD;
&#xD;
      Design This was a randomized, double-blind, placebo-controlled clinical trial. Setting This&#xD;
      study was conducted at Princess Nourah Bint Abdulrahman University's (PNU's) dental clinic in&#xD;
      Riyadh, Saudi Arabia.&#xD;
&#xD;
      Materials and Methods Participants Pediatric patients were referred to the study by&#xD;
      clinicians at the PNU clinic. Inclusion criteria included: child must have been age five&#xD;
      through 13; child must be undergoing a simple extraction under local anesthesia of one or&#xD;
      more symptomatic primary molars including teeth with pathology such as abscess, cyst, and&#xD;
      internal resorption; parent must provide consent and the child provide assent; child must not&#xD;
      have any systematic disease, child must not be taking any medication that interacts with&#xD;
      ibuprofen (the NSAID used in this study), and child must be cooperative. Children were&#xD;
      excluded for known allergy or having ever had an allergic reaction to ibuprofen; taking&#xD;
      antibiotics or other medications; having special needs due to a physical or mental&#xD;
      disability; having been given an analgesic prior to appointment by guardian; or being treated&#xD;
      for an emergency medical condition (e.g., cellulitis). This study was reviewed and approved&#xD;
      by the PNU Research Ethics Board (REB).&#xD;
&#xD;
      Records of potential participants were reviewed prior to inviting them into study&#xD;
      participation so that they were already screened for inclusion and exclusion criteria and&#xD;
      they were known to qualify. This was a clinical study, and recruitment was limited to&#xD;
      participants who qualified, although a total sample size of 60 was thought to be possible and&#xD;
      so was targeted.&#xD;
&#xD;
      Randomization, Blinding, and Baseline Data Collection To facilitate double-blinding, a&#xD;
      professional research coordinator (RC) was hired to develop blinded materials. A list of&#xD;
      identification numbers was created and each number was randomly assigned to either Group A&#xD;
      (receive ibuprofen prior to extraction) or Group B (receive placebo prior to extraction, as a&#xD;
      control). Only the RC knew the assignment of the numbers to groups. Blinded medications were&#xD;
      developed and labeled according to the identification (ID) numbers.&#xD;
&#xD;
      Once participants underwent consent, they were assigned an ID number which placed them in a&#xD;
      randomized group. The clinician used the medication associated with the participant's ID&#xD;
      number prior to extraction. At this point, baseline data was gathered, which included the&#xD;
      following variables: patient gender, patient age, anesthesia technique used (infiltration for&#xD;
      upper mouth extractions, and nerve block for lower mouth extractions), number of teeth being&#xD;
      extracted, baseline self-reported pain measurement, and baseline self-reported anxiety&#xD;
      measurement.&#xD;
&#xD;
      Interventions Administration of Study Drug Once placed in a randomization group, the study&#xD;
      drug was administered. Those randomized to Group A (active) received the NSAID in the study,&#xD;
      which was oral commercially-available Nurfen® syrup containing the NSAID ibuprofen. Between&#xD;
      7.5 to 15 ml/kg was administered, depending on the child's age. Those randomized to Group B&#xD;
      (control) were given a colored, flavored solution as a placebo.&#xD;
&#xD;
      Tooth Extraction After administration of the study drug and baseline data collection, the&#xD;
      treating clinicians (n=6) followed a standard protocol for the study. Clinicians had 1 to 5&#xD;
      years of experience. No formal calibration was done, and behavioral management techniques&#xD;
      were included in the standard protocol. They reviewed the participant's medical and dental&#xD;
      histories and noted any allergies. After a thorough clinical and radiographic examination,&#xD;
      they applied topical anesthesia, then administered local anesthesia with dosage appropriate&#xD;
      to the patient's age and weight (Lidocaine 2% with epinephrine 1:100,000). After local&#xD;
      anesthesia, the efficacy of the anesthesia was tested subjectively and objectively, then&#xD;
      pediatric forceps were used for the extraction(s). This was followed by the application of a&#xD;
      gauze pressure pack, and verbal and written post-extraction instructions were provided to the&#xD;
      child and parent.&#xD;
&#xD;
      Main Outcome Methods Data Collection Two instruments were used for outcome measurement: the&#xD;
      Wong-Baker FACES scale (WBFS) for pain perception, and the Modified Child Dental Anxiety&#xD;
      Scale - Faces (MCDASf) for anxiety. Both the WBFS and MCDASf were administered at baseline&#xD;
      (immediately after consent), and at 3- and 24-hours post-extraction. It was estimated that&#xD;
      3-hours post-extraction, local analgesic would have worn off and pain would typically be at&#xD;
      its peak.&#xD;
&#xD;
      The baseline measurements were done in person by the RC, and both the 3- and 24-hour&#xD;
      follow-up measurements were conducted by the RC by phone. As both WBFS and MCDASf are visual&#xD;
      scales, forms were provided to the parent at the appointment which were then completed with&#xD;
      the child during the follow-up calls and sent to the RC in the mail. During the follow-up&#xD;
      phone calls, the researcher would talk on the phone to the parent, and coach them to ask the&#xD;
      child the questions and have the child answer them by pointing to the visual scale. The&#xD;
      parent would the relay the child's answer to the researcher for the record.&#xD;
&#xD;
      Measurements Intended for pediatrics patients, the WBFS has patients assign a score of 0, 2,&#xD;
      4, 6, 8, and 10 to indicate their level of perceived pain.&#xD;
&#xD;
      The MCDASf scale was developed and validated to measure dental-related anxiety in children&#xD;
      about eight different topics; only &quot;How do you feel about having a tooth taken out?&quot; was&#xD;
      asked in this study. Respondents assign a score between 1 and 5 corresponding to their level&#xD;
      of anxiety about the topic .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 10, 2019</start_date>
  <completion_date type="Actual">May 30, 2019</completion_date>
  <primary_completion_date type="Actual">March 28, 2019</primary_completion_date>
  <phase>Phase 3</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>
    <intervention_model_description>Randomized, double-blind, placebo-controlled clinical trial</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
    <masking_description>a professional research coordinator is hired to develop blinded materials. A list of identification numbers will be created, and each number will randomly be assigned to either Group A (receive ibuprofen prior to extraction) or Group B (receive placebo prior to extraction, as a control). Only the RC will know the assignment of the numbers to groups. Blinded medications will be developed and labelled according to the identification (ID) numbers.&#xD;
Once participants undergo consent, they will be assigned an ID number which placed them in a randomized group. The clinician will the medication associated with the participant's ID number prior to extraction.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>To compare pain and anxiety in pediatric tooth extraction patients receiving a preoperative NSAID vs. placebo</measure>
    <time_frame>First 24 hours after drug administration</time_frame>
    <description>Main Outcome Methods: measurement of the Wong Baker Faces (WBFS) scale has been used and patients assign a score of 0, 2, 4, 6, 8, and 10 to indicate their level of perceived pain.&#xD;
Score 10 is the highest level of pain</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">56</enrollment>
  <condition>Pain Management</condition>
  <arm_group>
    <arm_group_label>Ibuprofen</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>30 minutes before extraction, once/day orally</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>30 minutes before extraction, once/day orally</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>IBUPROFEN</intervention_name>
    <description>given to children 30 minutes before extraction / orally for one time only</description>
    <arm_group_label>Ibuprofen</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. child must be undergoing a simple extraction under local anesthesia of one or more&#xD;
             symptomatic primary molars including teeth with pathology such as abscess, cyst, and&#xD;
             internal resorption&#xD;
&#xD;
          2. parent must provide consent and the child provide assent&#xD;
&#xD;
          3. must not have any systematic disease&#xD;
&#xD;
          4. must not be taking any medication that interacts with ibuprofen (the NSAID used in&#xD;
             this study)&#xD;
&#xD;
          5. must be cooperative&#xD;
&#xD;
               -  Excluded Criteria Children were excluded for&#xD;
&#xD;
        1-known allergy 2-having ever had an allergic reaction to ibuprofen 3- taking antibiotics&#xD;
        or other medications 4-special needs due to a physical or mental disability 5-been given an&#xD;
        analgesic prior to appointment by the guardian; 6-being treated for an emergency medical&#xD;
        condition (e.g., cellulitis).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>13 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Abeer A Alshami, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Princess Noura Bint Abdulrhman University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>College of Dentistry /Princess Nourah Bint Abdulrhman University</name>
      <address>
        <city>Riyadh</city>
        <zip>11671</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Saudi Arabia</country>
  </location_countries>
  <results_reference>
    <citation>Ashley PF, Parekh S, Moles DR, Anand P, MacDonald LC. Preoperative analgesics for additional pain relief in children and adolescents having dental treatment. Cochrane Database Syst Rev. 2016 Aug 8;2016(8):CD008392. doi: 10.1002/14651858.CD008392.pub3.</citation>
    <PMID>27501304</PMID>
  </results_reference>
  <results_reference>
    <citation>Al-Namankany A, de Souza M, Ashley P. Evidence-based dentistry: analysis of dental anxiety scales for children. Br Dent J. 2012 Mar 9;212(5):219-22. doi: 10.1038/sj.bdj.2012.174.</citation>
    <PMID>22402535</PMID>
  </results_reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 9, 2020</study_first_submitted>
  <study_first_submitted_qc>July 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 17, 2020</study_first_posted>
  <last_update_submitted>July 14, 2020</last_update_submitted>
  <last_update_submitted_qc>July 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Princess Nourah Bint Abdulrahman University</investigator_affiliation>
    <investigator_full_name>Abeer ali alshami</investigator_full_name>
    <investigator_title>Assistant professor / Consultant in Pediatric dentistry</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ibuprofen</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>All of the individual participant data collected during the trial, after deidentification.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>Immediately following publication. No end date.</ipd_time_frame>
    <ipd_access_criteria>Anyone who wishes to access the data.</ipd_access_criteria>
  </patient_data>
  <!-- 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/NCT04476069
org study id: H-01-R059
nct id: NCT04476069
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Abstract Introduction: Administration of non-steroidal anti-inflammatory drugs (NSAIDs)
      before tooth extraction may reduce post-surgical pain, but there is a lack of research.

      Aims: To compare pain and anxiety in pediatric tooth extraction patients receiving a
      preoperative NSAID vs. placebo.

      Design: Randomized, double-blind, placebo-controlled clinical trial. Setting: Princess Nourah
      Bint Abdulrahman University's (PNU's) dental clinic in Riyadh, Saudi Arabia.

      Materials and Methods: Eligible pediatric tooth extraction patients were randomized to Group
      A, which received NSAID preoperatively, or Group B, which received placebo.

      Interventions: A research coordinator (RC) measured participants prior to extraction, and 3-
      and 24-hours post-extraction.

      Main Outcome Methods: The Wong-Baker FACES scale (WBFS) and the Modified Child Dental Anxiety
      Scale - Faces (MCDASf).
Aims The aim of this study was to compare the post-operative pain and anxiety experience of
      pediatric tooth extraction patients who receive a preoperative NSAID with those who receive a
      placebo in order to evaluate the impact of preoperative NSAID administration on post-surgical
      pain and anxiety.

      Design This was a randomized, double-blind, placebo-controlled clinical trial. Setting This
      study was conducted at Princess Nourah Bint Abdulrahman University's (PNU's) dental clinic in
      Riyadh, Saudi Arabia.

      Materials and Methods Participants Pediatric patients were referred to the study by
      clinicians at the PNU clinic. Inclusion criteria included: child must have been age five
      through 13; child must be undergoing a simple extraction under local anesthesia of one or
      more symptomatic primary molars including teeth with pathology such as abscess, cyst, and
      internal resorption; parent must provide consent and the child provide assent; child must not
      have any systematic disease, child must not be taking any medication that interacts with
      ibuprofen (the NSAID used in this study), and child must be cooperative. Children were
      excluded for known allergy or having ever had an allergic reaction to ibuprofen; taking
      antibiotics or other medications; having special needs due to a physical or mental
      disability; having been given an analgesic prior to appointment by guardian; or being treated
      for an emergency medical condition (e.g., cellulitis). This study was reviewed and approved
      by the PNU Research Ethics Board (REB).

      Records of potential participants were reviewed prior to inviting them into study
      participation so that they were already screened for inclusion and exclusion criteria and
      they were known to qualify. This was a clinical study, and recruitment was limited to
      participants who qualified, although a total sample size of 60 was thought to be possible and
      so was targeted.

      Randomization, Blinding, and Baseline Data Collection To facilitate double-blinding, a
      professional research coordinator (RC) was hired to develop blinded materials. A list of
      identification numbers was created and each number was randomly assigned to either Group A
      (receive ibuprofen prior to extraction) or Group B (receive placebo prior to extraction, as a
      control). Only the RC knew the assignment of the numbers to groups. Blinded medications were
      developed and labeled according to the identification (ID) numbers.

      Once participants underwent consent, they were assigned an ID number which placed them in a
      randomized group. The clinician used the medication associated with the participant's ID
      number prior to extraction. At this point, baseline data was gathered, which included the
      following variables: patient gender, patient age, anesthesia technique used (infiltration for
      upper mouth extractions, and nerve block for lower mouth extractions), number of teeth being
      extracted, baseline self-reported pain measurement, and baseline self-reported anxiety
      measurement.

      Interventions Administration of Study Drug Once placed in a randomization group, the study
      drug was administered. Those randomized to Group A (active) received the NSAID in the study,
      which was oral commercially-available Nurfen® syrup containing the NSAID ibuprofen. Between
      7.5 to 15 ml/kg was administered, depending on the child's age. Those randomized to Group B
      (control) were given a colored, flavored solution as a placebo.

      Tooth Extraction After administration of the study drug and baseline data collection, the
      treating clinicians (n=6) followed a standard protocol for the study. Clinicians had 1 to 5
      years of experience. No formal calibration was done, and behavioral management techniques
      were included in the standard protocol. They reviewed the participant's medical and dental
      histories and noted any allergies. After a thorough clinical and radiographic examination,
      they applied topical anesthesia, then administered local anesthesia with dosage appropriate
      to the patient's age and weight (Lidocaine 2% with epinephrine 1:100,000). After local
      anesthesia, the efficacy of the anesthesia was tested subjectively and objectively, then
      pediatric forceps were used for the extraction(s). This was followed by the application of a
      gauze pressure pack, and verbal and written post-extraction instructions were provided to the
      child and parent.

      Main Outcome Methods Data Collection Two instruments were used for outcome measurement: the
      Wong-Baker FACES scale (WBFS) for pain perception, and the Modified Child Dental Anxiety
      Scale - Faces (MCDASf) for anxiety. Both the WBFS and MCDASf were administered at baseline
      (immediately after consent), and at 3- and 24-hours post-extraction. It was estimated that
      3-hours post-extraction, local analgesic would have worn off and pain would typically be at
      its peak.

      The baseline measurements were done in person by the RC, and both the 3- and 24-hour
      follow-up measurements were conducted by the RC by phone. As both WBFS and MCDASf are visual
      scales, forms were provided to the parent at the appointment which were then completed with
      the child during the follow-up calls and sent to the RC in the mail. During the follow-up
      phone calls, the researcher would talk on the phone to the parent, and coach them to ask the
      child the questions and have the child answer them by pointing to the visual scale. The
      parent would the relay the child's answer to the researcher for the record.

      Measurements Intended for pediatrics patients, the WBFS has patients assign a score of 0, 2,
      4, 6, 8, and 10 to indicate their level of perceived pain.

      The MCDASf scale was developed and validated to measure dental-related anxiety in children
      about eight different topics; only "How do you feel about having a tooth taken out?" was
      asked in this study. Respondents assign a score between 1 and 5 corresponding to their level
      of anxiety about the topic .
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized, double-blind, placebo-controlled clinical trial
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Investigator)
masking description: a professional research coordinator is hired to develop blinded materials. A list of identification numbers will be created, and each number will randomly be assigned to either Group A (receive ibuprofen prior to extraction) or Group B (receive placebo prior to extraction, as a control). Only the RC will know the assignment of the numbers to groups. Blinded medications will be developed and labelled according to the identification (ID) numbers.
Once participants undergo consent, they will be assigned an ID number which placed them in a randomized group. The clinician will the medication associated with the participant's ID number prior to extraction.
measure: To compare pain and anxiety in pediatric tooth extraction patients receiving a preoperative NSAID vs. placebo
time frame: First 24 hours after drug administration
description: Main Outcome Methods: measurement of the Wong Baker Faces (WBFS) scale has been used and patients assign a score of 0, 2, 4, 6, 8, and 10 to indicate their level of perceived pain.
Score 10 is the highest level of pain
arm group label: Ibuprofen
arm group type: Experimental
description: 30 minutes before extraction, once/day orally
arm group label: Placebo
arm group type: Placebo Comparator
description: 30 minutes before extraction, once/day orally
intervention type: Drug
intervention name: IBUPROFEN
description: given to children 30 minutes before extraction / orally for one time only
arm group label: Ibuprofen
arm group label: Placebo
criteria: 
gender: All
minimum age: 5 Years
maximum age: 13 Years
healthy volunteers: No
last name: Abeer A Alshami, PhD
role: Principal Investigator
affiliation: Princess Noura Bint Abdulrhman University
facility: 
country: Saudi Arabia
citation: Ashley PF, Parekh S, Moles DR, Anand P, MacDonald LC. Preoperative analgesics for additional pain relief in children and adolescents having dental treatment. Cochrane Database Syst Rev. 2016 Aug 8;2016(8):CD008392. doi: 10.1002/14651858.CD008392.pub3.
PMID: 27501304
citation: Al-Namankany A, de Souza M, Ashley P. Evidence-based dentistry: analysis of dental anxiety scales for children. Br Dent J. 2012 Mar 9;212(5):219-22. doi: 10.1038/sj.bdj.2012.174.
PMID: 22402535
responsible party type: Principal Investigator
investigator affiliation: Princess Nourah Bint Abdulrahman University
investigator full name: Abeer ali alshami
investigator title: Assistant professor / Consultant in Pediatric dentistry
mesh term: Ibuprofen
sharing ipd: Yes
ipd description: All of the individual participant data collected during the trial, after deidentification.
ipd info type: Study Protocol
ipd time frame: Immediately following publication. No end date.
ipd access criteria: Anyone who wishes to access the data.