NCT01701778

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Yao Yusheng · Academic / Other
• Sex: Male
• Age: 2 Years – 5 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Inguinal Hernia
• Cryptorchidism

Interventions

Type	Name	Description
DRUG	Caudal Dexmedetomidine	Caudal: Levobupivacaine 0.25% 1ml/kg and dexmedetomidine 1µg/kg Intravenous: 10 ml normal saline
DRUG	Intravenous Dexmedetomidine	Caudal: Levobupivacaine 0.25% 1ml/kg Intravenous: dexmedetomidine 1µg/kg
DRUG	Placebo	Caudal: Levobupivacaine 0.25% 1ml/kg Intravenous: 10 ml normal saline
DRUG	sevoflurane	Induction and maintain anaesthesia

Timeline

• Start date: 2012-10-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2012-10-05
• Last updated: 2018-11-15

Locations

1 site across 1 country: China