<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/NCT02205580</url>
  </required_header>
  <id_info>
    <org_study_id>GZWCMC</org_study_id>
    <nct_id>NCT02205580</nct_id>
  </id_info>
  <brief_title>Continuous Intravenous Sufentanil Infusion for Postoperative Pain Management Following Tonsillectomy or Adeno-tonsillectomy in Children</brief_title>
  <official_title>Comparison of Three Different Rates of Continuous Intravenous Sufentanil Infusion for Postoperative Pain Management Following Coblation Tonsillectomy or Adeno-tonsillectomy in Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jin Ni</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Guangzhou Women and Children's Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Postoperative pain following tonsillectomy or adeno-tonsillectomy in children is severe and&#xD;
      sometimes last for days. Sufentanil is used by epidural route for postoperative analgesia in&#xD;
      children. There are few reports about its use for postoperative analgesia by continuous&#xD;
      intravenous infusion. Its complications include , hypoxia, sedation, pruritus ,nausea and/or&#xD;
      vomiting.&#xD;
&#xD;
      The investigators design this protocol to test efficacy of analgesia of three different rates&#xD;
      of continuous intravenous sufentanil infusion for postoperative pain management following&#xD;
      coblation tonsillectomy or adeno-tonsillectomy in children. The investigators also compare&#xD;
      incidence rate of complications for three groups.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">December 2014</completion_date>
  <primary_completion_date type="Anticipated">December 2014</primary_completion_date>
  <phase>Phase 4</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, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>objective pain score</measure>
    <time_frame>up to 48 hours after operation</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>incidence rate of hypoxia</measure>
    <time_frame>4h,8h,24h,48h after operation</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>incidence rate of pruritus</measure>
    <time_frame>4h,8h,24h,48h after operation</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>incidence rate of nausea and/or vomiting</measure>
    <time_frame>4h,8h,24h,48h after operation</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>incidence rate of sedation</measure>
    <time_frame>4h,8h,24h,48h after operation</time_frame>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Sleep Breathing Disorders</condition>
  <condition>Tonsillitis</condition>
  <condition>Adenoid Hypertrophy</condition>
  <arm_group>
    <arm_group_label>Sufentanil infusion rate 0.02μg•kg-1•h-1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sufentanil infusion rate 0.02μg•kg-1•h-1 lasted for 48 hours</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sufentanil infusion rate 0.03μg•kg-1•h-1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sufentanil infusion rate 0.03μg•kg-1•h-1 lasted for 48 hours</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sufentanil infusion rate 0.04μg•kg-1•h-1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sufentanil infusion rate 0.04μg•kg-1•h-1 lasted for 48 hours</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>continuous intravenous sufentanil 0.02μg•kg-1•h-1 infusion</intervention_name>
    <arm_group_label>Sufentanil infusion rate 0.02μg•kg-1•h-1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>continuous intravenous sufentanil 0.03μg•kg-1•h-1 infusion</intervention_name>
    <arm_group_label>Sufentanil infusion rate 0.03μg•kg-1•h-1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>continuous intravenous sufentanil 0.04μg•kg-1•h-1 infusion</intervention_name>
    <arm_group_label>Sufentanil infusion rate 0.04μg•kg-1•h-1</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiologists grade I or II children aged 5-8 years undergoing&#xD;
             coblation tonsillectomy or adeno-tonsillectomy as in-patient&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children with a history of adverse reaction to opioids, long-term use of opioid&#xD;
             medications, and history of chronic pain.&#xD;
&#xD;
          -  Psychiatric illness, kidney failure, hypotension, atrioventricular block, myasthenia&#xD;
             gravis etc.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>8 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jin Ni, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Guangzhou Women and Children's Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Guangzhou Women and Children's Medical Center</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510623</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>July 26, 2014</study_first_submitted>
  <study_first_submitted_qc>July 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 31, 2014</study_first_posted>
  <last_update_submitted>September 28, 2014</last_update_submitted>
  <last_update_submitted_qc>September 28, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 30, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Guangzhou Women and Children's Medical Center</investigator_affiliation>
    <investigator_full_name>Jin Ni</investigator_full_name>
    <investigator_title>Department of Anesthesiology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tonsillitis</mesh_term>
    <mesh_term>Pain, Postoperative</mesh_term>
    <mesh_term>Hypertrophy</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sufentanil</mesh_term>
    <mesh_term>Dsuvia</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/NCT02205580
org study id: GZWCMC
nct id: NCT02205580
lead sponsor: 
has dmc: Yes
Postoperative pain following tonsillectomy or adeno-tonsillectomy in children is severe and
      sometimes last for days. Sufentanil is used by epidural route for postoperative analgesia in
      children. There are few reports about its use for postoperative analgesia by continuous
      intravenous infusion. Its complications include , hypoxia, sedation, pruritus ,nausea and/or
      vomiting.

      The investigators design this protocol to test efficacy of analgesia of three different rates
      of continuous intravenous sufentanil infusion for postoperative pain management following
      coblation tonsillectomy or adeno-tonsillectomy in children. The investigators also compare
      incidence rate of complications for three groups.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: objective pain score
time frame: up to 48 hours after operation
measure: incidence rate of hypoxia
time frame: 4h,8h,24h,48h after operation
measure: incidence rate of pruritus
time frame: 4h,8h,24h,48h after operation
measure: incidence rate of nausea and/or vomiting
time frame: 4h,8h,24h,48h after operation
measure: incidence rate of sedation
time frame: 4h,8h,24h,48h after operation
arm group label: Sufentanil infusion rate 0.02μg•kg-1•h-1
arm group type: Experimental
description: Sufentanil infusion rate 0.02μg•kg-1•h-1 lasted for 48 hours
arm group label: Sufentanil infusion rate 0.03μg•kg-1•h-1
arm group type: Experimental
description: Sufentanil infusion rate 0.03μg•kg-1•h-1 lasted for 48 hours
arm group label: Sufentanil infusion rate 0.04μg•kg-1•h-1
arm group type: Experimental
description: Sufentanil infusion rate 0.04μg•kg-1•h-1 lasted for 48 hours
intervention type: Drug
intervention name: continuous intravenous sufentanil 0.02μg•kg-1•h-1 infusion
arm group label: Sufentanil infusion rate 0.02μg•kg-1•h-1
intervention type: Drug
intervention name: continuous intravenous sufentanil 0.03μg•kg-1•h-1 infusion
arm group label: Sufentanil infusion rate 0.03μg•kg-1•h-1
intervention type: Drug
intervention name: continuous intravenous sufentanil 0.04μg•kg-1•h-1 infusion
arm group label: Sufentanil infusion rate 0.04μg•kg-1•h-1
criteria: 
gender: All
minimum age: 5 Years
maximum age: 8 Years
healthy volunteers: No
last name: Jin Ni, M.D.
role: Principal Investigator
affiliation: Guangzhou Women and Children's Medical Center
facility: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Guangzhou Women and Children's Medical Center
investigator full name: Jin Ni
investigator title: Department of Anesthesiology
mesh term: Tonsillitis
mesh term: Pain, Postoperative
mesh term: Hypertrophy
mesh term: Sufentanil
mesh term: Dsuvia