NCT02416063

Caudal Versus Intravenous Dexmedetomidine for Caudal Analgesia in Children

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: University of Jordan · Academic / Other
• Sex: All
• Age: 1 Year – 6 Years
• Healthy volunteers: Not accepted

Summary

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.

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

Conditions

• Pain

Interventions

Type	Name	Description
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
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
DRUG	Placebo	Drug:Caudal bupivacaine 0.25% 1ml/kg Intravenous: Normal saline 10 ml sevoflurane Induction and maintenance of anesthesia

Timeline

• Start date: 2014-01-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2015-04-14
• Last updated: 2015-04-14