<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/NCT01686802</url>
  </required_header>
  <id_info>
    <org_study_id>102923</org_study_id>
    <nct_id>NCT01686802</nct_id>
  </id_info>
  <brief_title>Post-operative Oral Morphine Versus Ibuprofen</brief_title>
  <official_title>Oral Morphine Versus Ibuprofen for Post-operative Pain Management in Children: a Randomized Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lawson Health Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lawson Health Research Institute</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Children 5-17 years of age who have undergo orthopedic day surgical procedures for definitive&#xD;
      management of fractures, tendon release, etc. will be randomized to receive either ibuprofen&#xD;
      or oral morphine as needed for pain relief for 48 hours post-operatively at home. Pain will&#xD;
      be assessed using the self-report Faces pain scale revised (FPS-R). We hypothesize that oral&#xD;
      morphine will result in significantly lower pain scores on the Faces Pain Scale Revised&#xD;
      (FPS-R) compared to ibuprofen. It is hoped that the results of this trial will create a new&#xD;
      option for post-operative pain management in children.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">September 2016</primary_completion_date>
  <phase>Phase 2</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 (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in faces pain score pre and post intervention</measure>
    <time_frame>48 hours from the time of discharge from hospital.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in faces pain score pre and post intervention</measure>
    <time_frame>48 hours from the time of discharge from hospital</time_frame>
    <description>Second to eighth doses of intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse effects</measure>
    <time_frame>96 hours from first dose of intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants requiring acetaminophen for breakthrough pain</measure>
    <time_frame>48 hours from first dose of intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Unscheduled visits to a health care provider for pain</measure>
    <time_frame>96 hours from first dose of intervention</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">132</enrollment>
  <condition>Post-operative Pain</condition>
  <arm_group>
    <arm_group_label>ibuprofen</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>ibuprofen 10 mg/kg (max 600 mg) every 6 hours as needed for pain (maximum 8 doses) from the time the patient is discharged from hospital as deemed by the physician to a maximum of 48 hours.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>oral morphine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>oral morphine 0.5 mg/kg (max 20 mg) every 6 hours as needed for pain (maximum 8 doses) from the time the patient is discharged from hospital as deemed by the physician to a maximum of 48 hours.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>oral morphine</intervention_name>
    <arm_group_label>oral morphine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ibuprofen</intervention_name>
    <arm_group_label>ibuprofen</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  all children aged 5-17 years who undergo an elective orthopedic or fracture-related&#xD;
             surgical procedure at the Children's Hospital in London, Ontario and have a same-day&#xD;
             discharge.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  known hypersensitivity to either ibuprofen or morphine&#xD;
&#xD;
          -  chronic users of NSAIDS or opioids&#xD;
&#xD;
          -  cognitive impairment&#xD;
&#xD;
          -  poor English fluency&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  acute or chronic renal insufficiency&#xD;
&#xD;
          -  bleeding disorder&#xD;
&#xD;
          -  obstructive sleep apnea&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Naveen Poonai, MSc MD FRCPC</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lawson Health Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>London Health Science Center</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 5W9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>September 13, 2012</study_first_submitted>
  <study_first_submitted_qc>September 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2012</study_first_posted>
  <last_update_submitted>December 27, 2016</last_update_submitted>
  <last_update_submitted_qc>December 27, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 28, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Lawson Health Research Institute</investigator_affiliation>
    <investigator_full_name>Naveen Poonai</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>oral morphine</keyword>
  <keyword>ibuprofen</keyword>
  <keyword>post-operative pain</keyword>
  <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>Ibuprofen</mesh_term>
    <mesh_term>Morphine</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/NCT01686802
org study id: 102923
nct id: NCT01686802
lead sponsor: 
has dmc: Yes
Children 5-17 years of age who have undergo orthopedic day surgical procedures for definitive
      management of fractures, tendon release, etc. will be randomized to receive either ibuprofen
      or oral morphine as needed for pain relief for 48 hours post-operatively at home. Pain will
      be assessed using the self-report Faces pain scale revised (FPS-R). We hypothesize that oral
      morphine will result in significantly lower pain scores on the Faces Pain Scale Revised
      (FPS-R) compared to ibuprofen. It is hoped that the results of this trial will create a new
      option for post-operative pain management in children.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change in faces pain score pre and post intervention
time frame: 48 hours from the time of discharge from hospital.
measure: Change in faces pain score pre and post intervention
time frame: 48 hours from the time of discharge from hospital
description: Second to eighth doses of intervention
measure: Adverse effects
time frame: 96 hours from first dose of intervention
measure: Number of participants requiring acetaminophen for breakthrough pain
time frame: 48 hours from first dose of intervention
measure: Unscheduled visits to a health care provider for pain
time frame: 96 hours from first dose of intervention
arm group label: ibuprofen
arm group type: Active Comparator
description: ibuprofen 10 mg/kg (max 600 mg) every 6 hours as needed for pain (maximum 8 doses) from the time the patient is discharged from hospital as deemed by the physician to a maximum of 48 hours.
arm group label: oral morphine
arm group type: Active Comparator
description: oral morphine 0.5 mg/kg (max 20 mg) every 6 hours as needed for pain (maximum 8 doses) from the time the patient is discharged from hospital as deemed by the physician to a maximum of 48 hours.
intervention type: Drug
intervention name: oral morphine
arm group label: oral morphine
intervention type: Drug
intervention name: Ibuprofen
arm group label: ibuprofen
criteria: 
gender: All
minimum age: 5 Years
maximum age: 17 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Naveen Poonai, MSc MD FRCPC
role: Principal Investigator
affiliation: Lawson Health Research Institute
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Lawson Health Research Institute
investigator full name: Naveen Poonai
investigator title: Principal Investigator
mesh term: Pain, Postoperative
mesh term: Ibuprofen
mesh term: Morphine