Caudal Versus Intravenous Dexmedetomidine for Supplementation of Caudal Analgesia in Children

November 13, 2018 updated by: Yao Yusheng

Double-blind Randomized Controlled Trial of Caudal Versus Intravenous Dexmedetomidine for Supplementation of Caudal Analgesia in Children

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

90

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Fujian Provincial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Drug: Caudal Dexmedetomidine

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

Intravenous: 10 ml normal saline

Other Names:
  • Precedex
Drug: sevoflurane
Induction and maintain anaesthesia
Experimental: Intravenous Dexmedetomidine

Caudal: Levobupivacaine 0.25% 1ml/kg

Intravenous: dexmedetomidine 1µg/kg

Anesthesia was induced and maintained with sevoflurane
Drug: sevoflurane
Induction and maintain anaesthesia
Drug: Intravenous Dexmedetomidine

Caudal: Levobupivacaine 0.25% 1ml/kg

Intravenous: dexmedetomidine 1µg/kg

Other Names:
  • Precedex
Placebo Comparator: Placebo

Caudal: Levobupivacaine 0.25% 1ml/kg

Intravenous: 10 ml normal saline

Anesthesia was induced and maintained with sevoflurane
Drug: sevoflurane
Induction and maintain anaesthesia
Drug: Placebo

Caudal: Levobupivacaine 0.25% 1ml/kg

Intravenous: 10 ml normal saline

Other Names:
  • Levobupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
From the administration of the caudal block to the first registration of a CHIPPS scores≥4,assessed up to 24h

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the number of patients not requiring rescue analgesia
Time Frame: After surgery,up to 24h
the quality of postoperative pain control
After surgery,up to 24h
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
After surgery, every 15min for the first 2 h, every 30min for the next 2h, hourly for the next 4h
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
After awake,participants will be followed every 30min for the first 2h, hourly for the next 4h
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)
Participants will be followed for the duration of PACU stay, an expected average of 2 hours
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
From the administration of the caudal block until the end of study period, assessed up to postoperative 24h
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)
after surgery, 30min for first 4h, hourly for the next 4h and thereafter every 2h,assessed up to 24h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yao Yusheng

Collaborators

West China Hospital

Investigators

  • Principal Investigator: Yanqing Chen, M.D., Fujian Provicial Hospital
  • Study Director: Jin Liu, M.D., West China Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

October 2, 2012

First Submitted That Met QC Criteria

October 4, 2012

First Posted (Estimate)

October 5, 2012

Study Record Updates

Last Update Posted (Actual)

November 15, 2018

Last Update Submitted That Met QC Criteria

November 13, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FujianPH
  • FujianPH-TRC-121002 (Registry Identifier: Fujian Provicial Hospital)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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