Caudal Versus Intravenous Dexmedetomidine for Caudal Analgesia in Children

April 8, 2015 updated by: Khaled Radian Al-zaben, University of Jordan

Caudal Versus Intravenous Dexmedetomidine for Caudal Analgesia in Children: A Randomised Controlled Double Blind Study

The aim of this prospective randomized double-blind study was to compare the analgesic efficacy and the side effects of dexmedetomidine (1 µg.kg-1) co-administered with bupivacaine for caudal analgesia or intravenously in children undergoing infra-umbilical surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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 dexmedetomidine 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 bupivacaine in children undergoing infra-umbilical surgery.

75 children (ASAⅠorⅡ,aged 1-6 yr) undergoing infra-umbilical surgery 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 B-Dcau (n = 25): Caudal bupivacaine 0.25% 1ml/kg plus dexmedetomidine 1µg/kg and 10 ml normal saline i.v.;Group B-Div (n = 25): bupivacaine 0.25% 1ml/kg and dexmedetomidine 1µg/kg(10 ml)i.v.;Group B(n = 25): bupivacaine 0.25% and 10 ml normal saline intravenous

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Phase 2

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 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with American Society of Anesthesiologists (ASA) - I
  • Scheduled for lower abdominal and perineal surgery
  • Under general anesthesia

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
  • Children with uncorrected cardiac lesions
  • Children with heart block

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: caudal Dexmedetomidine

Drug:Caudal Bupivacaine 0.25% 1ml/kg .

Drug:caudal Dexmedetomidine 1μg /kg.

Intravenous :10 ml normal saline

Anesthesia was induced and maintained with sevoflurane
Drug: Caudal Dexmedetomidine

Drug:Caudal bupivacaine 0.25% 1ml/kg

Drug: Caudal dexmedetomidine 1µg/kg

Intravenous: 10 ml normal saline

sevoflurane Induction and maintenance of anesthesia

Other Names:
  • Precedex
  • dexmedetomidine
Active Comparator: Intravenous Dexmedetomidine

Drug:Caudal bupivacaine 0.25% 1ml/kg

Drug: Intravenous dexmedetomidine 1µg/kg in a 10 ml volume normal saline

Anesthesia was induced and maintained with sevoflurane
Drug: Intravenous dexmedetomidine

Drug:Caudal bupivacaine 0.25% 1ml/kg.

Drug:Intravenous dexmedetomidine1 μg /kg in a total volume of 10 ml

sevoflurane Induction and maintenance of anesthesia

Other Names:
  • precedex
Placebo Comparator: Placebo

Caudal: bupivacaine 0.25% 1ml/kg .

Intravenous: 10 ml Normal saline

Anesthesia was induced and maintained with sevoflurane
Drug: Placebo

Drug:Caudal bupivacaine 0.25% 1ml/kg

Intravenous: Normal saline 10 ml

sevoflurane Induction and maintenance of anesthesia

Other Names:
  • normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to first analgesic requirement
Time Frame: 24 hours
Time to first rescue medication. The time from end of surgery to the first requirement of postoperative analgesia,pain score ≥4
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative behaviour scores
Time Frame: 2 hours
behaviour score was recorded throughout the post-anesthesia care unit stay at 15-minute time intervals.
2 hours
Sevoflurane concentration
Time Frame: 1 hour
Sevoflurane concentration required to maintain Bispectral Index (BIS) monitor reading between 40 and 60
1 hour
Blood pressure Perioperative blood pressure readings
Time Frame: 2 hours
Perioperative blood pressure readings
2 hours
Heart Rate
Time Frame: 2 hours
Perioperative heart rate readings
2 hours
the incidence of emergence agitation
Time Frame: 2 hours
Participants will be followed for the duration of PACU stay, an expected average of 2 hours
2 hours
Postoperative pain scores
Time Frame: 24 hours
postoperative pain score will be assessed over 24 hours
24 hours
Side effects
Time Frame: 24 hours
side effects including nausea, vomiting and urinary retention and lower limb weakness
24 hours

Collaborators and Investigators

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

Sponsor

University of Jordan

Investigators

  • Principal Investigator: khaled R Al-zaben, University of Jordan

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

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

January 1, 2014

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

March 12, 2015

First Submitted That Met QC Criteria

April 8, 2015

First Posted (Estimate)

April 14, 2015

Study Record Updates

Last Update Posted (Estimate)

April 14, 2015

Last Update Submitted That Met QC Criteria

April 8, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Faculty of medicine-JU

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.

Clinical Trials on Pain

Clinical Trials on Caudal Dexmedetomidine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Russia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe