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Caudal Versus Intravenous Dexmedetomidine for Supplementation of Caudal Analgesia in Children

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ClinicalTrials.gov Identifier: NCT01701778
Recruitment Status : Completed
First Posted : October 5, 2012
Last Update Posted : November 15, 2018
Sponsor:
Collaborator:
West China Hospital
Information provided by (Responsible Party):
Yao Yusheng, Fujian Provincial Hospital

Tracking Information
First Submitted Date  ICMJE October 2, 2012
First Posted Date  ICMJE October 5, 2012
Last Update Posted Date November 15, 2018
Study Start Date  ICMJE October 2012
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 4, 2012)
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 ]
the Children and Infants Postoperative Pain Scale (CHIPPS)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 4, 2012)
  • the number of patients not requiring rescue analgesia [ Time Frame: After surgery,up to 24h ]
    the quality of postoperative pain control
  • 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 ]
    sedation was assessed using the Modified Ramsay Sedation Score
  • Residual motor block [ Time Frame: After awake,participants will be followed every 30min for the first 2h, hourly for the next 4h ]
    the degree of motor blockade was assessed using a modified Bromage scale
  • the incidence of emergence agitation [ Time Frame: Participants will be followed for the duration of PACU stay, an expected average of 2 hours ]
    The incidence of emergence agitation was evaluated by the Pediatric Anesthesia Emergence Delirium Scale(PAED)
  • side effects [ Time Frame: From the administration of the caudal block until the end of study period, assessed up to postoperative 24h ]
    side effects including bradycardia, hypotension, hypoxemia, nausea, vomiting and urinary retention
  • Pain intensity [ Time Frame: after surgery, 30min for first 4h, hourly for the next 4h and thereafter every 2h,assessed up to 24h ]
    Participants will be assessed with Children and Infants Postoperative Pain Scale (CHIPPS)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Caudal Versus Intravenous Dexmedetomidine for Supplementation of Caudal Analgesia in Children
Official Title  ICMJE Double-blind Randomized Controlled Trial of Caudal Versus Intravenous Dexmedetomidine for Supplementation of Caudal Analgesia in Children
Brief Summary 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.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Inguinal Hernia
  • Cryptorchidism
Intervention  ICMJE
  • Drug: Caudal Dexmedetomidine

    Caudal: Levobupivacaine 0.25% 1ml/kg and dexmedetomidine 1µg/kg

    Intravenous: 10 ml normal saline

    Other Name: Precedex
  • Drug: Intravenous Dexmedetomidine

    Caudal: Levobupivacaine 0.25% 1ml/kg

    Intravenous: dexmedetomidine 1µg/kg

    Other Name: Precedex
  • Drug: Placebo

    Caudal: Levobupivacaine 0.25% 1ml/kg

    Intravenous: 10 ml normal saline

    Other Name: Levobupivacaine
  • Drug: sevoflurane
    Induction and maintain anaesthesia
Study Arms  ICMJE
  • Experimental: Caudal Dexmedetomidine

    Caudal: Levobupivacaine 0.25% 1ml/kg and dexmedetomidine 1µg/kg

    Intravenous: 10 ml normal saline

    Anesthesia was induced and maintained with sevoflurane

    Interventions:
    • Drug: Caudal Dexmedetomidine
    • Drug: sevoflurane
  • Experimental: Intravenous Dexmedetomidine

    Caudal: Levobupivacaine 0.25% 1ml/kg

    Intravenous: dexmedetomidine 1µg/kg

    Anesthesia was induced and maintained with sevoflurane

    Interventions:
    • Drug: Intravenous Dexmedetomidine
    • Drug: sevoflurane
  • Placebo Comparator: Placebo

    Caudal: Levobupivacaine 0.25% 1ml/kg

    Intravenous: 10 ml normal saline

    Anesthesia was induced and maintained with sevoflurane

    Interventions:
    • Drug: Placebo
    • Drug: sevoflurane
Publications * Yao Y, Yu C, Zhang X, Guo Y, Zheng X. Caudal and intravenous dexmedetomidine similarly prolong the duration of caudal analgesia in children: A randomized controlled trial. Paediatr Anaesth. 2018 Oct;28(10):888-896. doi: 10.1111/pan.13469.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 4, 2012)
90
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2014
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • ASA status I-II
  • aged 2-5 yr
  • Undergoing unilateral orchiopexy/inguinal hernia repair

Exclusion Criteria:

  • Hypersensitivity to any local anesthetics
  • Patient has history of allergy, intolerance, or reaction to dexmedetomidine
  • Infections at puncture sites
  • Bleeding diathesis
  • Preexisting neurological disease
  • Diabetes mellitus
  • Children with uncorrected cardiac lesions
  • Children with heart block or liver impairment
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 2 Years to 5 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01701778
Other Study ID Numbers  ICMJE FujianPH
FujianPH-TRC-121002 ( Registry Identifier: Fujian Provicial Hospital )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yao Yusheng, Fujian Provincial Hospital
Study Sponsor  ICMJE Yao Yusheng
Collaborators  ICMJE West China Hospital
Investigators  ICMJE
Principal Investigator: Yusheng Yao, M.D. Fujian Provincial Hospital
Principal Investigator: Yanqing Chen, M.D. Fujian Provicial Hospital
Study Director: Jin Liu, M.D. West China Hospital
PRS Account Fujian Provincial Hospital
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP