Caudal Versus Intravenous Dexmedetomidine for Caudal Analgesia in Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2014-10-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Caudal Dexmedetomidine

Intervention Type DRUG

Drug:Caudal bupivacaine 0.25% 1ml/kg

Drug: Caudal dexmedetomidine 1µg/kg

Intravenous: 10 ml normal saline

sevoflurane Induction and maintenance of anesthesia

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

Group Type ACTIVE_COMPARATOR

Intravenous dexmedetomidine

Intervention Type DRUG

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

Placebo

Caudal: bupivacaine 0.25% 1ml/kg .

Intravenous: 10 ml Normal saline

Anesthesia was induced and maintained with sevoflurane

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Drug:Caudal bupivacaine 0.25% 1ml/kg

Intravenous: Normal saline 10 ml

sevoflurane Induction and maintenance of anesthesia

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Placebo

Drug:Caudal bupivacaine 0.25% 1ml/kg

Intravenous: Normal saline 10 ml

sevoflurane Induction and maintenance of anesthesia

Intervention Type DRUG

Other Intervention Names

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dexmedetomidine Precedex precedex normal saline

Eligibility Criteria

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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

Minimum Eligible Age

1 Year

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No