<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/NCT01701778</url>
  </required_header>
  <id_info>
    <org_study_id>FujianPH</org_study_id>
    <secondary_id>FujianPH-TRC-121002</secondary_id>
    <nct_id>NCT01701778</nct_id>
  </id_info>
  <brief_title>Caudal Versus Intravenous Dexmedetomidine for Supplementation of Caudal Analgesia in Children</brief_title>
  <official_title>Double-blind Randomized Controlled Trial of Caudal Versus Intravenous Dexmedetomidine for Supplementation of Caudal Analgesia in Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yao Yusheng</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>West China Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Fujian Provincial Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare the effects of caudal dexmedetomidine with&#xD;
      intravenous dexmedetomidine on caudal levobupivacaine analgesia in children undergoing lower&#xD;
      abdominal surgeries.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Single shot caudal epidural block is one of the most widespread technique for pediatric pain&#xD;
      management after infraumbilical surgical procedures.However, in a significant proportion of&#xD;
      patients, despite good initial analgesia from a caudal block with local anesthetic, pain&#xD;
      develops after the block resolves.&#xD;
&#xD;
      Dexmedetomidine is used increasingly in pediatric anesthesia practice to prolong the duration&#xD;
      of action of caudal block with a local anesthetic agent.But which route of administration of&#xD;
      clonidine is the most beneficial remains unknown.&#xD;
&#xD;
      The investigators performed prospective randomized double-blind study to compare the effects&#xD;
      of caudal dexmedetomidine with intravenous dexmedetomidine on postoperative analgesia after&#xD;
      caudal levobupivacaine for inguinal herniorrhaphy or orchidopexy surgery.&#xD;
&#xD;
      90 children (ASAⅠorⅡ,aged 2-5 yr) undergoing unilateral orchiopexy or inguinal herniorrhaphy&#xD;
      were included in this study. Anesthesia was induced with sevoflurane via a facemask, followed&#xD;
      by placement of a laryngeal mask airway. Anesthesia was maintained with sevoflurane 2-3% in&#xD;
      oxygen-air.Then,caudal block was applied. Patients were randomly assigned in three groups.&#xD;
      Group Cau-DEX (n = 30): Caudal Levobupivacaine 0.25% 1ml/kg plus dexmedetomidine 1µg/kg and&#xD;
      10 ml normal saline i.v.;Group IV-DEX(n = 30): Levobupivacaine 0.25% 1ml/kg and&#xD;
      dexmedetomidine 1µg/kg(10 ml)i.v.;Group Placebo(n = 30): Levobupivacaine 0.25% and 10 ml&#xD;
      normal saline intravenous.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">January 2014</completion_date>
  <primary_completion_date type="Actual">January 2014</primary_completion_date>
  <phase>Phase 2</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>Supportive Care</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to first rescue medication</measure>
    <time_frame>From the administration of the caudal block to the first registration of a CHIPPS scores≥4,assessed up to 24h</time_frame>
    <description>the Children and Infants Postoperative Pain Scale (CHIPPS)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>the number of patients not requiring rescue analgesia</measure>
    <time_frame>After surgery,up to 24h</time_frame>
    <description>the quality of postoperative pain control</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the sedation score</measure>
    <time_frame>After surgery, every 15min for the first 2 h, every 30min for the next 2h, hourly for the next 4h</time_frame>
    <description>sedation was assessed using the Modified Ramsay Sedation Score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Residual motor block</measure>
    <time_frame>After awake,participants will be followed every 30min for the first 2h, hourly for the next 4h</time_frame>
    <description>the degree of motor blockade was assessed using a modified Bromage scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the incidence of emergence agitation</measure>
    <time_frame>Participants will be followed for the duration of PACU stay, an expected average of 2 hours</time_frame>
    <description>The incidence of emergence agitation was evaluated by the Pediatric Anesthesia Emergence Delirium Scale(PAED)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>side effects</measure>
    <time_frame>From the administration of the caudal block until the end of study period, assessed up to postoperative 24h</time_frame>
    <description>side effects including bradycardia, hypotension, hypoxemia, nausea, vomiting and urinary retention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain intensity</measure>
    <time_frame>after surgery, 30min for first 4h, hourly for the next 4h and thereafter every 2h,assessed up to 24h</time_frame>
    <description>Participants will be assessed with Children and Infants Postoperative Pain Scale (CHIPPS)</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Inguinal Hernia</condition>
  <condition>Cryptorchidism</condition>
  <arm_group>
    <arm_group_label>Caudal Dexmedetomidine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Caudal: Levobupivacaine 0.25% 1ml/kg and dexmedetomidine 1µg/kg&#xD;
Intravenous: 10 ml normal saline&#xD;
Anesthesia was induced and maintained with sevoflurane</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intravenous Dexmedetomidine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Caudal: Levobupivacaine 0.25% 1ml/kg&#xD;
Intravenous: dexmedetomidine 1µg/kg&#xD;
Anesthesia was induced and maintained with sevoflurane</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Caudal: Levobupivacaine 0.25% 1ml/kg&#xD;
Intravenous: 10 ml normal saline&#xD;
Anesthesia was induced and maintained with sevoflurane</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Caudal Dexmedetomidine</intervention_name>
    <description>Caudal: Levobupivacaine 0.25% 1ml/kg and dexmedetomidine 1µg/kg&#xD;
Intravenous: 10 ml normal saline</description>
    <arm_group_label>Caudal Dexmedetomidine</arm_group_label>
    <other_name>Precedex</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Intravenous Dexmedetomidine</intervention_name>
    <description>Caudal: Levobupivacaine 0.25% 1ml/kg&#xD;
Intravenous: dexmedetomidine 1µg/kg</description>
    <arm_group_label>Intravenous Dexmedetomidine</arm_group_label>
    <other_name>Precedex</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Caudal: Levobupivacaine 0.25% 1ml/kg&#xD;
Intravenous: 10 ml normal saline</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Levobupivacaine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>sevoflurane</intervention_name>
    <description>Induction and maintain anaesthesia</description>
    <arm_group_label>Caudal Dexmedetomidine</arm_group_label>
    <arm_group_label>Intravenous Dexmedetomidine</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA status I-II&#xD;
&#xD;
          -  aged 2-5 yr&#xD;
&#xD;
          -  Undergoing unilateral orchiopexy/inguinal hernia repair&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hypersensitivity to any local anesthetics&#xD;
&#xD;
          -  Patient has history of allergy, intolerance, or reaction to dexmedetomidine&#xD;
&#xD;
          -  Infections at puncture sites&#xD;
&#xD;
          -  Bleeding diathesis&#xD;
&#xD;
          -  Preexisting neurological disease&#xD;
&#xD;
          -  Diabetes mellitus&#xD;
&#xD;
          -  Children with uncorrected cardiac lesions&#xD;
&#xD;
          -  Children with heart block or liver impairment&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>5 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yusheng Yao, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fujian Provincial Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yanqing Chen, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fujian Provicial Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jin Liu, M.D.</last_name>
    <role>Study Director</role>
    <affiliation>West China Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fujian Provincial Hospital</name>
      <address>
        <city>Fuzhou</city>
        <state>Fujian</state>
        <zip>350001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <link>
    <url>http://bja.oxfordjournals.org/content/103/2/268.full</url>
    <description>Addition of clonidine or dexmedetomidine to bupivacaine prolongs caudal analgesia in children</description>
  </link>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>October 2, 2012</study_first_submitted>
  <study_first_submitted_qc>October 4, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 5, 2012</study_first_posted>
  <last_update_submitted>November 13, 2018</last_update_submitted>
  <last_update_submitted_qc>November 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 15, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Fujian Provincial Hospital</investigator_affiliation>
    <investigator_full_name>Yao Yusheng</investigator_full_name>
    <investigator_title>Double-blind randomized controlled trial of caudal versus intravenous dexmedetomidine for supplementation of caudal analgesia in children</investigator_title>
  </responsible_party>
  <keyword>Dexmedetomidine</keyword>
  <keyword>Postoperative pain reaction</keyword>
  <keyword>anesthesia</keyword>
  <keyword>children</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cryptorchidism</mesh_term>
    <mesh_term>Hernia, Inguinal</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexmedetomidine</mesh_term>
    <mesh_term>Sevoflurane</mesh_term>
    <mesh_term>Levobupivacaine</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/NCT01701778
org study id: FujianPH
secondary id: FujianPH-TRC-121002
nct id: NCT01701778
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to compare the effects of caudal dexmedetomidine with
      intravenous dexmedetomidine on caudal levobupivacaine analgesia in children undergoing lower
      abdominal surgeries.
Single shot caudal epidural block is one of the most widespread technique for pediatric pain
      management after infraumbilical surgical procedures.However, in a significant proportion of
      patients, despite good initial analgesia from a caudal block with local anesthetic, pain
      develops after the block resolves.

      Dexmedetomidine is used increasingly in pediatric anesthesia practice to prolong the duration
      of action of caudal block with a local anesthetic agent.But which route of administration of
      clonidine is the most beneficial remains unknown.

      The investigators performed prospective randomized double-blind study to compare the effects
      of caudal dexmedetomidine with intravenous dexmedetomidine on postoperative analgesia after
      caudal levobupivacaine for inguinal herniorrhaphy or orchidopexy surgery.

      90 children (ASAⅠorⅡ,aged 2-5 yr) undergoing unilateral orchiopexy or inguinal herniorrhaphy
      were included in this study. Anesthesia was induced with sevoflurane via a facemask, followed
      by placement of a laryngeal mask airway. Anesthesia was maintained with sevoflurane 2-3% in
      oxygen-air.Then,caudal block was applied. Patients were randomly assigned in three groups.
      Group Cau-DEX (n = 30): Caudal Levobupivacaine 0.25% 1ml/kg plus dexmedetomidine 1µg/kg and
      10 ml normal saline i.v.;Group IV-DEX(n = 30): Levobupivacaine 0.25% 1ml/kg and
      dexmedetomidine 1µg/kg(10 ml)i.v.;Group Placebo(n = 30): Levobupivacaine 0.25% and 10 ml
      normal saline intravenous.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Time to first rescue medication
time frame: From the administration of the caudal block to the first registration of a CHIPPS scores≥4,assessed up to 24h
description: the Children and Infants Postoperative Pain Scale (CHIPPS)
measure: the number of patients not requiring rescue analgesia
time frame: After surgery,up to 24h
description: the quality of postoperative pain control
measure: the sedation score
time frame: After surgery, every 15min for the first 2 h, every 30min for the next 2h, hourly for the next 4h
description: sedation was assessed using the Modified Ramsay Sedation Score
measure: Residual motor block
time frame: After awake,participants will be followed every 30min for the first 2h, hourly for the next 4h
description: the degree of motor blockade was assessed using a modified Bromage scale
measure: the incidence of emergence agitation
time frame: Participants will be followed for the duration of PACU stay, an expected average of 2 hours
description: The incidence of emergence agitation was evaluated by the Pediatric Anesthesia Emergence Delirium Scale(PAED)
measure: side effects
time frame: From the administration of the caudal block until the end of study period, assessed up to postoperative 24h
description: side effects including bradycardia, hypotension, hypoxemia, nausea, vomiting and urinary retention
measure: Pain intensity
time frame: after surgery, 30min for first 4h, hourly for the next 4h and thereafter every 2h,assessed up to 24h
description: Participants will be assessed with Children and Infants Postoperative Pain Scale (CHIPPS)
arm group label: Caudal Dexmedetomidine
arm group type: Experimental
description: Caudal: Levobupivacaine 0.25% 1ml/kg and dexmedetomidine 1µg/kg
Intravenous: 10 ml normal saline
Anesthesia was induced and maintained with sevoflurane
arm group label: Intravenous Dexmedetomidine
arm group type: Experimental
description: Caudal: Levobupivacaine 0.25% 1ml/kg
Intravenous: dexmedetomidine 1µg/kg
Anesthesia was induced and maintained with sevoflurane
arm group label: Placebo
arm group type: Placebo Comparator
description: Caudal: Levobupivacaine 0.25% 1ml/kg
Intravenous: 10 ml normal saline
Anesthesia was induced and maintained with sevoflurane
intervention type: Drug
intervention name: Caudal Dexmedetomidine
description: Caudal: Levobupivacaine 0.25% 1ml/kg and dexmedetomidine 1µg/kg
Intravenous: 10 ml normal saline
arm group label: Caudal Dexmedetomidine
other name: Precedex
intervention type: Drug
intervention name: Intravenous Dexmedetomidine
description: Caudal: Levobupivacaine 0.25% 1ml/kg
Intravenous: dexmedetomidine 1µg/kg
arm group label: Intravenous Dexmedetomidine
other name: Precedex
intervention type: Drug
intervention name: Placebo
description: Caudal: Levobupivacaine 0.25% 1ml/kg
Intravenous: 10 ml normal saline
arm group label: Placebo
other name: Levobupivacaine
intervention type: Drug
intervention name: sevoflurane
description: Induction and maintain anaesthesia
arm group label: Caudal Dexmedetomidine
arm group label: Intravenous Dexmedetomidine
arm group label: Placebo
criteria: 
gender: Male
minimum age: 2 Years
maximum age: 5 Years
healthy volunteers: No
last name: Yusheng Yao, M.D.
role: Principal Investigator
affiliation: Fujian Provincial Hospital
last name: Yanqing Chen, M.D.
role: Principal Investigator
affiliation: Fujian Provicial Hospital
last name: Jin Liu, M.D.
role: Study Director
affiliation: West China Hospital
facility: 
country: China
url: http://bja.oxfordjournals.org/content/103/2/268.full
description: Addition of clonidine or dexmedetomidine to bupivacaine prolongs caudal analgesia in children
responsible party type: Sponsor-Investigator
investigator affiliation: Fujian Provincial Hospital
investigator full name: Yao Yusheng
investigator title: Double-blind randomized controlled trial of caudal versus intravenous dexmedetomidine for supplementation of caudal analgesia in children
mesh term: Cryptorchidism
mesh term: Hernia, Inguinal
mesh term: Dexmedetomidine
mesh term: Sevoflurane
mesh term: Levobupivacaine