<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/NCT01680939</url>
  </required_header>
  <id_info>
    <org_study_id>OSAS-HHSC2012</org_study_id>
    <nct_id>NCT01680939</nct_id>
  </id_info>
  <brief_title>Investigating the Safety of Post-surgical Analgesics in Children With Obstructive Sleep Apnea</brief_title>
  <official_title>Investigating the Safety of Morphine and Ibuprofen in Children Post-adenotonsillectomy for Obstructive Sleep Apnea</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hamilton Health Sciences Corporation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Hospital for Sick Children</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Western Ontario, Canada</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hamilton Health Sciences Corporation</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Every year thousands of young children with obstructive sleep apnea undergo surgery which&#xD;
      requires them to be prescribed pain medication. The current standard in North America is&#xD;
      administration of opioids, mainly codeine or morphine; however in many areas of the world&#xD;
      including Canada, nonsteroidal anti-inflammatory medications such as ibuprofen are used. Some&#xD;
      North American surgeons are uncertain regarding the potential of ibuprofen to increase&#xD;
      bleeding following surgery. The results of research studies have been inconclusive overall.&#xD;
      Due to recent codeine fatalities in children following adenotonsillectomy, codeine has been&#xD;
      removed from the formulary at many Pediatric institutions. Some surgeons have begun to use&#xD;
      oral morphine as an alternate to codeine, which necessitates the need to find safe&#xD;
      alternative analgesics in this treatment group.&#xD;
&#xD;
      The primary objectives of this study is to assess the safety(1) and efficacy (2) of morphine&#xD;
      and ibuprofen in children with sleep apnea.&#xD;
&#xD;
      An interim analysis will be conducted after recruitment of 70 patients, to monitor both&#xD;
      safety and efficacy&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>May 2012</start_date>
  <primary_completion_date type="Anticipated">December 2013</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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety</measure>
    <time_frame>1.5 years</time_frame>
    <description>Safety will be assessed by comparing changes in respiratory parameters (oxygen saturation and the number of apnea events per night) following adenotonsillectomy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Effectiveness</measure>
    <time_frame>1.5 years</time_frame>
    <description>Analgesic effectiveness between treatment groups will be assessed using the visual analog scale and the objective pain scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Risk Factors</measure>
    <time_frame>1.5 years</time_frame>
    <description>Age, BMI, OSA severity and genetic factors will be compared between treatment groups. Furthermore, these factors will be isolated to determine any correlation exists with respiratory parameter improvement in all enrolled patients.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Pediatric Obstructive Sleep Apnea Syndrome</condition>
  <arm_group>
    <arm_group_label>Morphine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Receives morphine for post-surgical pain</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ibuprofen</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Receives ibuprofen for post-surgical pain</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Morphine</intervention_name>
    <description>0.2-0.5 mg/kg PO q4h</description>
    <arm_group_label>Morphine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ibuprofen</intervention_name>
    <description>10mg/kg PO q6hrs</description>
    <arm_group_label>Ibuprofen</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosed with OSAS,&#xD;
&#xD;
          -  scheduled for tonsillectomy plus/minus adenoid removal at MUMC,&#xD;
&#xD;
          -  between the ages of 1-10years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  contraindications to analgesia,&#xD;
&#xD;
          -  asthma,&#xD;
&#xD;
          -  has had previous adenotonsillectomy, or&#xD;
&#xD;
          -  any craniofacial,&#xD;
&#xD;
          -  neuromuscular or cardiac conditions&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>10 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Lauren Kelly, MSc. BMSc. PHD candidate</last_name>
    <phone>(519) 661-2111</phone>
    <phone_ext>83221</phone_ext>
    <email>lkelly27@uwo.ca</email>
  </overall_contact>
  <location>
    <facility>
      <name>McMaster University Medical Centre</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8N3Z5</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Doron Sommer, MD</last_name>
    </contact>
    <investigator>
      <last_name>Doron Sommer, MD FRCSC</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>May 2013</verification_date>
  <study_first_submitted>September 4, 2012</study_first_submitted>
  <study_first_submitted_qc>September 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 7, 2012</study_first_posted>
  <last_update_submitted>May 24, 2013</last_update_submitted>
  <last_update_submitted_qc>May 24, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 27, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hamilton Health Sciences Corporation</investigator_affiliation>
    <investigator_full_name>Doron Sommer</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Pediatrics</keyword>
  <keyword>Obstructive Sleep Apnea</keyword>
  <keyword>Adenotonsillectomy</keyword>
  <keyword>Analgesia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Apnea</mesh_term>
    <mesh_term>Sleep Apnea Syndromes</mesh_term>
    <mesh_term>Sleep Apnea, Obstructive</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>
  <pending_results>
    <submitted>February 19, 2014</submitted>
    <returned>April 2, 2014</returned>
    <submitted>October 18, 2014</submitted>
    <returned>November 4, 2014</returned>
  </pending_results>
  <!-- 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/NCT01680939
org study id: OSAS-HHSC2012
nct id: NCT01680939
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
Every year thousands of young children with obstructive sleep apnea undergo surgery which
      requires them to be prescribed pain medication. The current standard in North America is
      administration of opioids, mainly codeine or morphine; however in many areas of the world
      including Canada, nonsteroidal anti-inflammatory medications such as ibuprofen are used. Some
      North American surgeons are uncertain regarding the potential of ibuprofen to increase
      bleeding following surgery. The results of research studies have been inconclusive overall.
      Due to recent codeine fatalities in children following adenotonsillectomy, codeine has been
      removed from the formulary at many Pediatric institutions. Some surgeons have begun to use
      oral morphine as an alternate to codeine, which necessitates the need to find safe
      alternative analgesics in this treatment group.

      The primary objectives of this study is to assess the safety(1) and efficacy (2) of morphine
      and ibuprofen in children with sleep apnea.

      An interim analysis will be conducted after recruitment of 70 patients, to monitor both
      safety and efficacy
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Safety
time frame: 1.5 years
description: Safety will be assessed by comparing changes in respiratory parameters (oxygen saturation and the number of apnea events per night) following adenotonsillectomy.
measure: Effectiveness
time frame: 1.5 years
description: Analgesic effectiveness between treatment groups will be assessed using the visual analog scale and the objective pain scale
measure: Risk Factors
time frame: 1.5 years
description: Age, BMI, OSA severity and genetic factors will be compared between treatment groups. Furthermore, these factors will be isolated to determine any correlation exists with respiratory parameter improvement in all enrolled patients.
arm group label: Morphine
arm group type: Experimental
description: Receives morphine for post-surgical pain
arm group label: Ibuprofen
arm group type: Experimental
description: Receives ibuprofen for post-surgical pain
intervention type: Drug
intervention name: Morphine
description: 0.2-0.5 mg/kg PO q4h
arm group label: Morphine
intervention type: Drug
intervention name: Ibuprofen
description: 10mg/kg PO q6hrs
arm group label: Ibuprofen
criteria: 
gender: All
minimum age: 1 Year
maximum age: 10 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Lauren Kelly, MSc. BMSc. PHD candidate
phone: (519) 661-2111
phone ext: 83221
email: lkelly27@uwo.ca
facility: 
status: Recruiting
contact: 
investigator: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Hamilton Health Sciences Corporation
investigator full name: Doron Sommer
investigator title: MD
mesh term: Apnea
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive
mesh term: Ibuprofen
mesh term: Morphine
submitted: February 19, 2014
returned: April 2, 2014
submitted: October 18, 2014
returned: November 4, 2014