<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/NCT01690780</url>
  </required_header>
  <id_info>
    <org_study_id>R-11-340</org_study_id>
    <secondary_id>18091</secondary_id>
    <nct_id>NCT01690780</nct_id>
  </id_info>
  <brief_title>Oral Morphine Versus Ibuprofen</brief_title>
  <official_title>Oral Morphine Versus Ibuprofen for Post-fracture Pain Management in Children: a Randomized Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Naveen Poonai</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lawson Health Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Children 5-17 years of age who have sustained a non-operative distal forearm (radius and/or&#xD;
      ulna) or clavicular fracture will be randomized to receive either ibuprofen or oral morphine&#xD;
      as needed for pain relief for the first 24 hours following discharge from the emergency&#xD;
      department. Pain will be assessed using the self-report Faces pain scale revised (FPS-R). We&#xD;
      hypothesize that oral morphine will result in greater pain relief than ibuprofen.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">February 2014</completion_date>
  <primary_completion_date type="Actual">February 2014</primary_completion_date>
  <phase>N/A</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Faces Pain scale - revised</measure>
    <time_frame>30 minutes post intervention compared to baseline</time_frame>
    <description>The primary outcome variable is the pre-post intervention difference in pain scores as measured by self-reported Faces Pain Scale - Revised (FPS-R) for the first 24 hours post-fracture management following the as needed administration of the study drugs.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Acetaminophen doses</measure>
    <time_frame>24 hours</time_frame>
    <description>The secondary outcome variable is the number of breakthrough acetaminophen doses required/taken by the participant for the first 24 hours post-fracture management</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">183</enrollment>
  <condition>Upper Extremity Fractures</condition>
  <condition>Analgesia Post Fracture</condition>
  <arm_group>
    <arm_group_label>Ibuprofen</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Oral morphine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oral morphine</intervention_name>
    <description>oral morphine 0.5 mg/kg (max 10 mg) every 6 hours as needed for 24 hours</description>
    <arm_group_label>Oral morphine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ibuprofen</intervention_name>
    <description>Ibuprofen 10 mg/kg (max 600 mg) every 6 hours as needed for pain (maximum 4 doses) for 24 hours following discharge from the emergency department</description>
    <arm_group_label>Ibuprofen</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with known hypersensitivity to either ibuprofen or morphine&#xD;
&#xD;
          -  chronic users of NSAIDS or opioids&#xD;
&#xD;
          -  fractures requiring operative management&#xD;
&#xD;
          -  associated injuries requiring analgesia&#xD;
&#xD;
          -  poor English fluency&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients aged 5 to 17 years with a non-operative forearm or distal radius fracture&#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, MD, FRCPC</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lawson Health Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>London Health Sciences Center</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A5W9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>September 13, 2012</study_first_submitted>
  <study_first_submitted_qc>September 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 24, 2012</study_first_posted>
  <last_update_submitted>July 15, 2014</last_update_submitted>
  <last_update_submitted_qc>July 15, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 16, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-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>fracture</keyword>
  <keyword>pediatric</keyword>
  <keyword>oral morphine</keyword>
  <keyword>ibuprofen</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fractures, Bone</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/NCT01690780
org study id: R-11-340
secondary id: 18091
nct id: NCT01690780
lead sponsor: 
has dmc: No
Children 5-17 years of age who have sustained a non-operative distal forearm (radius and/or
      ulna) or clavicular fracture will be randomized to receive either ibuprofen or oral morphine
      as needed for pain relief for the first 24 hours following discharge from the emergency
      department. Pain will be assessed using the self-report Faces pain scale revised (FPS-R). We
      hypothesize that oral morphine will result in greater pain relief than ibuprofen.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Faces Pain scale - revised
time frame: 30 minutes post intervention compared to baseline
description: The primary outcome variable is the pre-post intervention difference in pain scores as measured by self-reported Faces Pain Scale - Revised (FPS-R) for the first 24 hours post-fracture management following the as needed administration of the study drugs.
measure: Acetaminophen doses
time frame: 24 hours
description: The secondary outcome variable is the number of breakthrough acetaminophen doses required/taken by the participant for the first 24 hours post-fracture management
arm group label: Ibuprofen
arm group type: Active Comparator
arm group label: Oral morphine
arm group type: Experimental
intervention type: Drug
intervention name: Oral morphine
description: oral morphine 0.5 mg/kg (max 10 mg) every 6 hours as needed for 24 hours
arm group label: Oral morphine
intervention type: Drug
intervention name: Ibuprofen
description: Ibuprofen 10 mg/kg (max 600 mg) every 6 hours as needed for pain (maximum 4 doses) for 24 hours following discharge from the emergency department
arm group label: Ibuprofen
criteria: 
gender: All
minimum age: 5 Years
maximum age: 17 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Naveen Poonai, MD, FRCPC
role: Principal Investigator
affiliation: Lawson Health Research Institute
facility: 
country: Canada
responsible party type: Sponsor-Investigator
investigator affiliation: Lawson Health Research Institute
investigator full name: Naveen Poonai
investigator title: Principal Investigator
mesh term: Fractures, Bone
mesh term: Ibuprofen
mesh term: Morphine