<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/NCT02987985</url>
  </required_header>
  <id_info>
    <org_study_id>BIO 16-255</org_study_id>
    <nct_id>NCT02987985</nct_id>
  </id_info>
  <brief_title>Efficacy of Opioid-free Anesthesia in Reducing Postoperative Respiratory Depression in Children Undergoing Tonsillectomy</brief_title>
  <official_title>Efficacy of Opioid-free Anesthesia in Reducing Postoperative Respiratory Depression in Children Undergoing Tonsillectomy: a Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Saskatchewan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Saskatchewan</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this trial is to determine whether an opioid-free general anesthetic (OFA)&#xD;
      technique utilizing ketamine, dexmedetomidine, lidocaine, and gabapentin can help reduce&#xD;
      postoperative respiratory depression in the post-anesthesia care unit and ward in children&#xD;
      with sleep-disordered breathing undergoing tonsillectomy when compared with traditional&#xD;
      opioid-containing techniques. It is expected that this OFA regimen will have a measurable&#xD;
      reduction on postoperative respiratory depression in children with sleep-disordered&#xD;
      breathing.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of this trial is to determine whether an opioid-free general anesthetic can&#xD;
      help reduce postoperative respiratory depression in the post-anesthesia care unit and ward in&#xD;
      children with sleep-disordered breathing undergoing tonsillectomy when compared with&#xD;
      traditional opioid-containing techniques.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 15, 2017</start_date>
  <completion_date type="Actual">December 20, 2020</completion_date>
  <primary_completion_date type="Actual">September 20, 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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Respiratory depression</measure>
    <time_frame>24 hours following surgery</time_frame>
    <description>Number of desaturation events (oxygen saturation by pulse oximetry (SPO2) &lt;90%) as measured by a Masimo Radical-7 pulse oximeter during the first postoperative night's sleep</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quantified opioid consumption</measure>
    <time_frame>24 hours following surgery</time_frame>
    <description>Quantified opioid consumption</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pediatric Agitation Emergence Delirium (PAED) scale</measure>
    <time_frame>24 hours following surgery</time_frame>
    <description>Pediatric Agitation Emergence Delirium (PAED) scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Face Legs Activity Cry Consolability (FLACC) scale</measure>
    <time_frame>24 hours following surgery</time_frame>
    <description>Face Legs Activity Cry Consolability (FLACC) scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time until Post Anesthesia Care Unit (PACU) discharge readiness</measure>
    <time_frame>24 hours following surgery</time_frame>
    <description>Time until Post Anesthesia Care Unit (PACU) discharge readiness</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Other adverse effects</measure>
    <time_frame>24 hours following surgery</time_frame>
    <description>Other adverse effects</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Anesthesia</condition>
  <condition>General Anesthesia</condition>
  <condition>Analgesics, Opioid</condition>
  <condition>Postoperative Complications</condition>
  <condition>Pathologic Processes</condition>
  <condition>Physiologic Effects of Drugs</condition>
  <condition>Narcotics</condition>
  <condition>Analgesics</condition>
  <condition>Sleep Disordered Breathing</condition>
  <condition>Obstructive Sleep Apnea of Child</condition>
  <condition>Tonsillectomy</condition>
  <condition>Respiratory Depression</condition>
  <condition>Dexmedetomidine</condition>
  <condition>Ketamine</condition>
  <condition>Lidocaine</condition>
  <condition>Gabapentin</condition>
  <condition>Pulse Oximetry</condition>
  <arm_group>
    <arm_group_label>Opioid-free anesthesia</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Opioid-free preoperative medications, Opioid-free pre-intubation medications, Opioid-free maintenance medication, postoperative nausea and vomiting prophylaxis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Opioid-sparing anesthesia</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Opioid-sparing preoperative medications, Opioid sparing pre-intubation medications, Opioid-sparing maintenance medications, postoperative nausea and vomiting prophylaxis</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Acetaminophen, gabapentin</intervention_name>
    <description>acetaminophen 15 mg/kg, gabapentin 10 mg/kg</description>
    <arm_group_label>Opioid-free anesthesia</arm_group_label>
    <other_name>Opioid-free preoperative medications</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Acetaminophen</intervention_name>
    <description>acetaminophen 15 mg/kg</description>
    <arm_group_label>Opioid-sparing anesthesia</arm_group_label>
    <other_name>Opioid-sparing preoperative medications</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ketamine , Lidocaine , Dexmedetomidine</intervention_name>
    <description>Ketamine 0.5 mg/kg, Lidocaine 1 mg/kg, Dexmedetomidine 0.3 mcg/kg</description>
    <arm_group_label>Opioid-free anesthesia</arm_group_label>
    <other_name>Opioid-free pre-intubation medications</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fentanyl, Dexmedetomidine</intervention_name>
    <description>Fentanyl 0.5 mcg/kg, Dexmedetomidine 0.3 mcg/kg</description>
    <arm_group_label>Opioid-sparing anesthesia</arm_group_label>
    <other_name>Opioid sparing pre-intubation medications</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone , Ondansetron</intervention_name>
    <description>Dexamethasone 150 mcg/kg, Ondansetron 50 mg/kg</description>
    <arm_group_label>Opioid-free anesthesia</arm_group_label>
    <arm_group_label>Opioid-sparing anesthesia</arm_group_label>
    <other_name>Postoperative nausea and vomiting prophylaxis</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sevoflurane</intervention_name>
    <description>Sevoflurane (dose titrated to effect)</description>
    <arm_group_label>Opioid-free anesthesia</arm_group_label>
    <other_name>Opioid-free maintenance medication</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sevoflurane, Fentanyl</intervention_name>
    <description>Sevoflurane (dose titrated to effect), Fentanyl as needed (dose at anesthesiologist's discretion)</description>
    <arm_group_label>Opioid-sparing anesthesia</arm_group_label>
    <other_name>Opioid-sparing maintenance medications</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged 0-12 years with Sleep Disordered Breathing (SDB) who are scheduled for&#xD;
             elective Tonsillectomy/AdenoTonsillectomy (T/AT) will be recruited at Royal University&#xD;
             Hospital, Saskatoon, Saskatchewan.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age &gt; 12; American Society of Anesthesiologists (ASA) Classification &gt; IV; significant&#xD;
             cardiorespiratory, neurological, craniofacial, hepatic, renal, or genetic disorders,&#xD;
             excluding SDB; concomitant surgical procedures other than myringotomy and tubes; and&#xD;
             allergy to any of the study drugs&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jon Gamble, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Saskatchewan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Royal University Hospital</name>
      <address>
        <city>Saskatoon</city>
        <state>Saskatchewan</state>
        <zip>S7N 0W8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>November 29, 2016</study_first_submitted>
  <study_first_submitted_qc>December 8, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <last_update_submitted>August 6, 2021</last_update_submitted>
  <last_update_submitted_qc>August 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 10, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Saskatchewan</investigator_affiliation>
    <investigator_full_name>Jonathan Gamble</investigator_full_name>
    <investigator_title>Principle Investigator</investigator_title>
  </responsible_party>
  <keyword>Opioid-sparing</keyword>
  <keyword>Opioid-free</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Apnea Syndromes</mesh_term>
    <mesh_term>Sleep Apnea, Obstructive</mesh_term>
    <mesh_term>Respiratory Insufficiency</mesh_term>
    <mesh_term>Postoperative Complications</mesh_term>
    <mesh_term>Pathologic Processes</mesh_term>
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acetaminophen</mesh_term>
    <mesh_term>Dexamethasone</mesh_term>
    <mesh_term>Lidocaine</mesh_term>
    <mesh_term>Fentanyl</mesh_term>
    <mesh_term>Dexmedetomidine</mesh_term>
    <mesh_term>Ketamine</mesh_term>
    <mesh_term>Gabapentin</mesh_term>
    <mesh_term>Analgesics, Opioid</mesh_term>
    <mesh_term>Ondansetron</mesh_term>
    <mesh_term>Sevoflurane</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT02987985
org study id: BIO 16-255
nct id: NCT02987985
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The objective of this trial is to determine whether an opioid-free general anesthetic (OFA)
      technique utilizing ketamine, dexmedetomidine, lidocaine, and gabapentin can help reduce
      postoperative respiratory depression in the post-anesthesia care unit and ward in children
      with sleep-disordered breathing undergoing tonsillectomy when compared with traditional
      opioid-containing techniques. It is expected that this OFA regimen will have a measurable
      reduction on postoperative respiratory depression in children with sleep-disordered
      breathing.
The objective of this trial is to determine whether an opioid-free general anesthetic can
      help reduce postoperative respiratory depression in the post-anesthesia care unit and ward in
      children with sleep-disordered breathing undergoing tonsillectomy when compared with
      traditional opioid-containing techniques.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Respiratory depression
time frame: 24 hours following surgery
description: Number of desaturation events (oxygen saturation by pulse oximetry (SPO2) <90%) as measured by a Masimo Radical-7 pulse oximeter during the first postoperative night's sleep
measure: Quantified opioid consumption
time frame: 24 hours following surgery
description: Quantified opioid consumption
measure: Pediatric Agitation Emergence Delirium (PAED) scale
time frame: 24 hours following surgery
description: Pediatric Agitation Emergence Delirium (PAED) scale
measure: Face Legs Activity Cry Consolability (FLACC) scale
time frame: 24 hours following surgery
description: Face Legs Activity Cry Consolability (FLACC) scale
measure: Time until Post Anesthesia Care Unit (PACU) discharge readiness
time frame: 24 hours following surgery
description: Time until Post Anesthesia Care Unit (PACU) discharge readiness
measure: Other adverse effects
time frame: 24 hours following surgery
description: Other adverse effects
arm group label: Opioid-free anesthesia
arm group type: Experimental
description: Opioid-free preoperative medications, Opioid-free pre-intubation medications, Opioid-free maintenance medication, postoperative nausea and vomiting prophylaxis
arm group label: Opioid-sparing anesthesia
arm group type: Active Comparator
description: Opioid-sparing preoperative medications, Opioid sparing pre-intubation medications, Opioid-sparing maintenance medications, postoperative nausea and vomiting prophylaxis
intervention type: Drug
intervention name: Acetaminophen, gabapentin
description: acetaminophen 15 mg/kg, gabapentin 10 mg/kg
arm group label: Opioid-free anesthesia
other name: Opioid-free preoperative medications
intervention type: Drug
intervention name: Acetaminophen
description: acetaminophen 15 mg/kg
arm group label: Opioid-sparing anesthesia
other name: Opioid-sparing preoperative medications
intervention type: Drug
intervention name: Ketamine , Lidocaine , Dexmedetomidine
description: Ketamine 0.5 mg/kg, Lidocaine 1 mg/kg, Dexmedetomidine 0.3 mcg/kg
arm group label: Opioid-free anesthesia
other name: Opioid-free pre-intubation medications
intervention type: Drug
intervention name: Fentanyl, Dexmedetomidine
description: Fentanyl 0.5 mcg/kg, Dexmedetomidine 0.3 mcg/kg
arm group label: Opioid-sparing anesthesia
other name: Opioid sparing pre-intubation medications
intervention type: Drug
intervention name: Dexamethasone , Ondansetron
description: Dexamethasone 150 mcg/kg, Ondansetron 50 mg/kg
arm group label: Opioid-free anesthesia
arm group label: Opioid-sparing anesthesia
other name: Postoperative nausea and vomiting prophylaxis
intervention type: Drug
intervention name: Sevoflurane
description: Sevoflurane (dose titrated to effect)
arm group label: Opioid-free anesthesia
other name: Opioid-free maintenance medication
intervention type: Drug
intervention name: Sevoflurane, Fentanyl
description: Sevoflurane (dose titrated to effect), Fentanyl as needed (dose at anesthesiologist's discretion)
arm group label: Opioid-sparing anesthesia
other name: Opioid-sparing maintenance medications
criteria: 
gender: All
minimum age: N/A
maximum age: 12 Years
healthy volunteers: No
last name: Jon Gamble, MD
role: Principal Investigator
affiliation: University of Saskatchewan
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of Saskatchewan
investigator full name: Jonathan Gamble
investigator title: Principle Investigator
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive
mesh term: Respiratory Insufficiency
mesh term: Postoperative Complications
mesh term: Pathologic Processes
mesh term: Depression
mesh term: Depressive Disorder
mesh term: Acetaminophen
mesh term: Dexamethasone
mesh term: Lidocaine
mesh term: Fentanyl
mesh term: Dexmedetomidine
mesh term: Ketamine
mesh term: Gabapentin
mesh term: Analgesics, Opioid
mesh term: Ondansetron
mesh term: Sevoflurane
sharing ipd: No