<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/NCT02990910</url>
  </required_header>
  <id_info>
    <org_study_id>IARA</org_study_id>
    <nct_id>NCT02990910</nct_id>
  </id_info>
  <brief_title>Individualized Analgesia After Adenotonsillectomy</brief_title>
  <official_title>Effects of an Individualized Analgesia Protocol on the Requirements of Medical Interventions After Adenotonsillectomy in Children Based on the Result of a Fentanyl Test: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Hospital of Fudan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Children's Hospital of Fudan University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A high incidence of respiratory morbidity after adenotonsillectomy is reported in children&#xD;
      with obstructive sleep apnea syndrome (OSAS). So we designed a prospective, double-blind,&#xD;
      randomized controlled study to determine the effects of individualized opioid analgesia&#xD;
      compared with conventional opioid analgesia on respiratory morbidity after adenotonsillectomy&#xD;
      in Children with OSAS.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All children were randomized 2 groups based on a computer-generated random number. The main&#xD;
      interventions were occurred in post anesthetic care unit (PACU). In the operating room, all&#xD;
      patients received a standardized anesthetic regimen by one anesthetist. Sevoflurane was used&#xD;
      for maintenance without any opioids. Before the end of the procedure, spontaneous respiratory&#xD;
      was recovered. All the patients were given 1 mcg/kg fentanyl intravenous injection after the&#xD;
      end of the procedure. The positive result was defined as spontaneous respiratory rate&#xD;
      decreased more than 50%, the others were defined as negative result. The result of fentanyl&#xD;
      test submitted to assistant, and prepared the rescue analgesic drugs according to this&#xD;
      result. One group: positive result 10μg/kg morphine; negative result 50μg/kg morphine.&#xD;
      Another group: all received 25μg/kg morphine .The trachea was extubated when patients were&#xD;
      awake, and then transported to the PACU. Patients with a Children's Hospital of Eastern&#xD;
      Ontario Pain Scale score&gt;6 received rescue analgesic drugs and observe respiratory morbidity&#xD;
      in each group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Actual">February 2017</completion_date>
  <primary_completion_date type="Actual">February 2017</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>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The Percentage of Patients Requiring at Least One Medical Intervention for Respiratory Events</measure>
    <time_frame>Time from entering the PACU until the patient leaves,approx 1 hour.</time_frame>
    <description>The medical interventions included instrumentation of the airway, bag/mask ventilation, and/or drug administration (succinylcholine, albuterol, or naloxone), which were classified as major medical interventions. The medical interventions also included repositioning of the child's airway, chin lift/jaw thrust maneuvers, and/or escalating to an oxygen mask, which were classified as minor medical interventions. Since oxygen by nasal cannula was delivered to all children recovering from anesthesia, escalating to an oxygen mask implied the patient need but higher concentration of oxygen to maintain SpO2 ≥ 95%.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Median Survival Time for CHEOPS Score &gt; 6.</measure>
    <time_frame>Time from entering the PACU until the patient leaves,approx 1 hour.</time_frame>
    <description>Pain was assessed and recorded through the East Ontario children's hospital pain score (CHEOPS).When the CHEOPS&gt;6,We thought it is painful. Comparing the median survival time (the time corresponding to pain percentage of 50% in two groups) for CHEOPS&gt;6 in two groups.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">280</enrollment>
  <condition>Analgesia</condition>
  <arm_group>
    <arm_group_label>Individualized opioid analgesia</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>One group: positive result 10μg/kg morphine; negative result 50μg/kg morphine.Scored every 10 minutes until CHEOPS&lt;=6 and Aldrete score&gt;9.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>conventional opioid analgesia</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Another group: all received 25μg/kg morphine .Scored every 10 minutes until CHEOPS&lt;=6 and Aldrete score&gt;9.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Individualized opioid analgesia</intervention_name>
    <description>(a）positive result 10μg/kg morphine; negative result 50μg/kg morphine.</description>
    <arm_group_label>Individualized opioid analgesia</arm_group_label>
    <other_name>IP</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>conventional opioid analgesia</intervention_name>
    <description>(b) all received 25μg/kg morphine</description>
    <arm_group_label>conventional opioid analgesia</arm_group_label>
    <other_name>CP</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  children with obstructive sleep apnea syndrome undergoing elective T&amp;A, ASA physical&#xD;
             status I-II&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  developmental delay cardiac and craniofacial abnormalities ASA classification III or&#xD;
             more body mass index more than the 95th percentile for age&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>10 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>xuan wang</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's Hospital of Fudan University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chilren's Hospital of Fudan University</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>201102</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>December 7, 2016</study_first_submitted>
  <study_first_submitted_qc>December 9, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <results_first_submitted>June 1, 2017</results_first_submitted>
  <results_first_submitted_qc>August 7, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">August 9, 2017</results_first_posted>
  <last_update_submitted>July 13, 2020</last_update_submitted>
  <last_update_submitted_qc>July 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Children's Hospital of Fudan University</investigator_affiliation>
    <investigator_full_name>Xuan Wang</investigator_full_name>
    <investigator_title>Doctor</investigator_title>
  </responsible_party>
  <keyword>respiratory adverse events</keyword>
  <keyword>adenotonsillectomy</keyword>
  <keyword>opioid analgesia</keyword>
  <keyword>children</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Agnosia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Analgesics, Opioid</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 15, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/10/NCT02990910/SAP_003.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>February 15, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/10/NCT02990910/ICF_004.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>February 15, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/10/NCT02990910/Prot_005.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>children who scheduled for adenotonsillectomy under general anesthesia</recruitment_details>
      <pre_assignment_details>Patients with a history of allergy, pulmonary or cardiac diseases were excluded.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Individualized Opioid Analgesia</title>
          <description>One group: positive result 10μg/kg morphine; negative result 50μg/kg morphine.Scored every 10 minutes until CHEOPS&lt;=6 and Aldrete score&gt;9.&#xD;
personalized opioid analgesia: (a）positive result 10μg/kg morphine; negative result 50μg/kg morphine.</description>
        </group>
        <group group_id="P2">
          <title>Conventional Opioid Analgesia</title>
          <description>Another group: all received 25μg/kg morphine .Scored every 10 minutes until CHEOPS&lt;=6 and Aldrete score&gt;9.&#xD;
conventional opioid analgesia: (b) all received 25μg/kg morphine</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="140"/>
                <participants group_id="P2" count="140"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="134"/>
                <participants group_id="P2" count="130"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Individualized Opioid Analgesia</title>
          <description>One group: positive result 10μg/kg morphine; negative result 50μg/kg morphine.Scored every 10 minutes until CHEOPS&lt;=6 and Aldrete score&gt;9.&#xD;
personalized opioid analgesia: (a）positive result 10μg/kg morphine; negative result 50μg/kg morphine.</description>
        </group>
        <group group_id="B2">
          <title>Conventional Opioid Analgesia</title>
          <description>Another group: all received 25μg/kg morphine .Scored every 10 minutes until CHEOPS&lt;=6 and Aldrete score&gt;9.&#xD;
conventional opioid analgesia: (b) all received 25μg/kg morphine</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="140"/>
            <count group_id="B2" value="140"/>
            <count group_id="B3" value="280"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="140"/>
                    <count group_id="B2" value="140"/>
                    <count group_id="B3" value="280"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6" lower_limit="4" upper_limit="8"/>
                    <measurement group_id="B2" value="5" lower_limit="4" upper_limit="6"/>
                    <measurement group_id="B3" value="6" lower_limit="4" upper_limit="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <population>The children with cough after intravenous fentanyl, the study was excluded</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="134"/>
                    <count group_id="B2" value="130"/>
                    <count group_id="B3" value="264"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="48"/>
                    <measurement group_id="B2" value="52"/>
                    <measurement group_id="B3" value="100"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="86"/>
                    <measurement group_id="B2" value="78"/>
                    <measurement group_id="B3" value="164"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="140"/>
                    <count group_id="B2" value="140"/>
                    <count group_id="B3" value="280"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="140"/>
                    <measurement group_id="B2" value="140"/>
                    <measurement group_id="B3" value="280"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="140"/>
                    <count group_id="B2" value="140"/>
                    <count group_id="B3" value="280"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="140"/>
                    <measurement group_id="B2" value="140"/>
                    <measurement group_id="B3" value="280"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Chinese</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="140"/>
                    <count group_id="B2" value="140"/>
                    <count group_id="B3" value="280"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="140"/>
                    <measurement group_id="B2" value="140"/>
                    <measurement group_id="B3" value="280"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>China</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="140"/>
                    <count group_id="B2" value="140"/>
                    <count group_id="B3" value="280"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="140"/>
                    <measurement group_id="B2" value="140"/>
                    <measurement group_id="B3" value="280"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <units>kg / m^2</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="140"/>
                    <count group_id="B2" value="140"/>
                    <count group_id="B3" value="280"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18" lower_limit="17" upper_limit="20"/>
                    <measurement group_id="B2" value="18" lower_limit="16" upper_limit="19"/>
                    <measurement group_id="B3" value="18" lower_limit="16" upper_limit="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>The Percentage of Patients Requiring at Least One Medical Intervention for Respiratory Events</title>
        <description>The medical interventions included instrumentation of the airway, bag/mask ventilation, and/or drug administration (succinylcholine, albuterol, or naloxone), which were classified as major medical interventions. The medical interventions also included repositioning of the child's airway, chin lift/jaw thrust maneuvers, and/or escalating to an oxygen mask, which were classified as minor medical interventions. Since oxygen by nasal cannula was delivered to all children recovering from anesthesia, escalating to an oxygen mask implied the patient need but higher concentration of oxygen to maintain SpO2 ≥ 95%.</description>
        <time_frame>Time from entering the PACU until the patient leaves,approx 1 hour.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Individualized Opioid Analgesia</title>
            <description>One group: positive result 10μg/kg morphine; negative result 50μg/kg morphine.Scored every 10 minutes until CHEOPS&lt;=6 and Aldrete score&gt;9.&#xD;
personalized opioid analgesia: (a）positive result 10μg/kg morphine; negative result 50μg/kg morphine.</description>
          </group>
          <group group_id="O2">
            <title>Conventional Opioid Analgesia</title>
            <description>Another group: all received 25μg/kg morphine .Scored every 10 minutes until CHEOPS&lt;=6 and Aldrete score&gt;9.&#xD;
conventional opioid analgesia: (b) all received 25μg/kg morphine</description>
          </group>
        </group_list>
        <measure>
          <title>The Percentage of Patients Requiring at Least One Medical Intervention for Respiratory Events</title>
          <description>The medical interventions included instrumentation of the airway, bag/mask ventilation, and/or drug administration (succinylcholine, albuterol, or naloxone), which were classified as major medical interventions. The medical interventions also included repositioning of the child's airway, chin lift/jaw thrust maneuvers, and/or escalating to an oxygen mask, which were classified as minor medical interventions. Since oxygen by nasal cannula was delivered to all children recovering from anesthesia, escalating to an oxygen mask implied the patient need but higher concentration of oxygen to maintain SpO2 ≥ 95%.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="134"/>
                <count group_id="O2" value="130"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Chi square test was used to compare the count data,p &lt; 0.05 was considered statistically significant.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.05</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Median Survival Time for CHEOPS Score &gt; 6.</title>
        <description>Pain was assessed and recorded through the East Ontario children's hospital pain score (CHEOPS).When the CHEOPS&gt;6,We thought it is painful. Comparing the median survival time (the time corresponding to pain percentage of 50% in two groups) for CHEOPS&gt;6 in two groups.</description>
        <time_frame>Time from entering the PACU until the patient leaves,approx 1 hour.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Individualized Opioid Analgesia</title>
            <description>One group: positive result 10μg/kg morphine; negative result 50μg/kg morphine.Scored every 10 minutes until CHEOPS&lt;=6 and Aldrete score&gt;9.&#xD;
personalized opioid analgesia: (a）positive result 10μg/kg morphine; negative result 50μg/kg morphine.</description>
          </group>
          <group group_id="O2">
            <title>Conventional Opioid Analgesia</title>
            <description>Another group: all received 25μg/kg morphine .Scored every 10 minutes until CHEOPS&lt;=6 and Aldrete score&gt;9.&#xD;
conventional opioid analgesia: (b) all received 25μg/kg morphine</description>
          </group>
        </group_list>
        <measure>
          <title>The Median Survival Time for CHEOPS Score &gt; 6.</title>
          <description>Pain was assessed and recorded through the East Ontario children's hospital pain score (CHEOPS).When the CHEOPS&gt;6,We thought it is painful. Comparing the median survival time (the time corresponding to pain percentage of 50% in two groups) for CHEOPS&gt;6 in two groups.</description>
          <units>minute</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="134"/>
                <count group_id="O2" value="130"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20" lower_limit="17" upper_limit="23"/>
                    <measurement group_id="O2" value="30" lower_limit="28" upper_limit="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Time from entering the PACU until the patient leaves,approx 1 hour.</time_frame>
      <desc>Respiratory adverse events were defined as an intervention requiring a nurse to maintain the SPO2 ≥95%.</desc>
      <group_list>
        <group group_id="E1">
          <title>Individualized Opioid Analgesia</title>
          <description>One group: positive result 10μg/kg morphine; negative result 50μg/kg morphine.Scored every 10 minutes until CHEOPS&lt;=6 and Aldrete score&gt;9.&#xD;
personalized opioid analgesia: (a）positive result 10μg/kg morphine; negative result 50μg/kg morphine.</description>
        </group>
        <group group_id="E2">
          <title>Conventional Opioid Analgesia</title>
          <description>Another group: all received 25μg/kg morphine .Scored every 10 minutes until CHEOPS&lt;=6 and Aldrete score&gt;9.&#xD;
conventional opioid analgesia: (b) all received 25μg/kg morphine</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="134"/>
                <counts group_id="E2" subjects_affected="29" subjects_at_risk="130"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="130"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>2</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="134"/>
                <counts group_id="E2" subjects_affected="22" subjects_at_risk="130"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Post Operative Nausea And Vomitting</sub_title>
                <counts group_id="E1" events="16" subjects_affected="16" subjects_at_risk="134"/>
                <counts group_id="E2" events="22" subjects_affected="22" subjects_at_risk="130"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>The absence of PSG assessment before surgery in patients recruited in this study is a limitation.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr.Wang Xuan</name_or_title>
      <organization>the Children's Hospital of Fudan University</organization>
      <phone>18017591058</phone>
      <email>744734170@qq.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02990910
org study id: IARA
nct id: NCT02990910
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A high incidence of respiratory morbidity after adenotonsillectomy is reported in children
      with obstructive sleep apnea syndrome (OSAS). So we designed a prospective, double-blind,
      randomized controlled study to determine the effects of individualized opioid analgesia
      compared with conventional opioid analgesia on respiratory morbidity after adenotonsillectomy
      in Children with OSAS.
All children were randomized 2 groups based on a computer-generated random number. The main
      interventions were occurred in post anesthetic care unit (PACU). In the operating room, all
      patients received a standardized anesthetic regimen by one anesthetist. Sevoflurane was used
      for maintenance without any opioids. Before the end of the procedure, spontaneous respiratory
      was recovered. All the patients were given 1 mcg/kg fentanyl intravenous injection after the
      end of the procedure. The positive result was defined as spontaneous respiratory rate
      decreased more than 50%, the others were defined as negative result. The result of fentanyl
      test submitted to assistant, and prepared the rescue analgesic drugs according to this
      result. One group: positive result 10μg/kg morphine; negative result 50μg/kg morphine.
      Another group: all received 25μg/kg morphine .The trachea was extubated when patients were
      awake, and then transported to the PACU. Patients with a Children's Hospital of Eastern
      Ontario Pain Scale score>6 received rescue analgesic drugs and observe respiratory morbidity
      in each group.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: The Percentage of Patients Requiring at Least One Medical Intervention for Respiratory Events
time frame: Time from entering the PACU until the patient leaves,approx 1 hour.
description: The medical interventions included instrumentation of the airway, bag/mask ventilation, and/or drug administration (succinylcholine, albuterol, or naloxone), which were classified as major medical interventions. The medical interventions also included repositioning of the child's airway, chin lift/jaw thrust maneuvers, and/or escalating to an oxygen mask, which were classified as minor medical interventions. Since oxygen by nasal cannula was delivered to all children recovering from anesthesia, escalating to an oxygen mask implied the patient need but higher concentration of oxygen to maintain SpO2 ≥ 95%.
measure: The Median Survival Time for CHEOPS Score > 6.
time frame: Time from entering the PACU until the patient leaves,approx 1 hour.
description: Pain was assessed and recorded through the East Ontario children's hospital pain score (CHEOPS).When the CHEOPS>6,We thought it is painful. Comparing the median survival time (the time corresponding to pain percentage of 50% in two groups) for CHEOPS>6 in two groups.
arm group label: Individualized opioid analgesia
arm group type: Other
description: One group: positive result 10μg/kg morphine; negative result 50μg/kg morphine.Scored every 10 minutes until CHEOPS<=6 and Aldrete score>9.
arm group label: conventional opioid analgesia
arm group type: Other
description: Another group: all received 25μg/kg morphine .Scored every 10 minutes until CHEOPS<=6 and Aldrete score>9.
intervention type: Drug
intervention name: Individualized opioid analgesia
description: (a）positive result 10μg/kg morphine; negative result 50μg/kg morphine.
arm group label: Individualized opioid analgesia
other name: IP
intervention type: Device
intervention name: conventional opioid analgesia
description: (b) all received 25μg/kg morphine
arm group label: conventional opioid analgesia
other name: CP
criteria: 
gender: All
minimum age: 3 Years
maximum age: 10 Years
healthy volunteers: No
last name: xuan wang
role: Principal Investigator
affiliation: Children's Hospital of Fudan University
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Children's Hospital of Fudan University
investigator full name: Xuan Wang
investigator title: Doctor
mesh term: Agnosia
mesh term: Analgesics, Opioid
sharing ipd: No
provided document: 
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The absence of PSG assessment before surgery in patients recruited in this study is a limitation.
point of contact: 