Trial | NCT01701778  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    90
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.
Study Started
Oct 31
2012
Primary Completion
Jan 31
2014
Study Completion
Jan 31
2014
Last Update
Nov 15
2018

Drug Caudal Dexmedetomidine

Caudal: Levobupivacaine 0.25% 1ml/kg and dexmedetomidine 1µg/kg Intravenous: 10 ml normal saline

  • Other names: Precedex

Drug Intravenous Dexmedetomidine

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

  • Other names: Precedex

Drug Placebo

Caudal: Levobupivacaine 0.25% 1ml/kg Intravenous: 10 ml normal saline

  • Other names: Levobupivacaine

Drug sevoflurane

Induction and maintain anaesthesia

Caudal Dexmedetomidine Experimental

Caudal: Levobupivacaine 0.25% 1ml/kg and dexmedetomidine 1µg/kg Intravenous: 10 ml normal saline Anesthesia was induced and maintained with sevoflurane

Intravenous Dexmedetomidine Experimental

Caudal: Levobupivacaine 0.25% 1ml/kg Intravenous: dexmedetomidine 1µg/kg Anesthesia was induced and maintained with sevoflurane

Placebo Placebo Comparator

Caudal: Levobupivacaine 0.25% 1ml/kg Intravenous: 10 ml normal saline Anesthesia was induced and maintained with sevoflurane

Criteria 

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
No Results Posted