A Comparative Study of the Effect of Epidural Dexmedetomidine Versus Fentanyl Added to Ropivacaine in Pediatric Orthopedic Surgery

Not Applicable

Completed

• Conditions: Congenital Skelectal Anomaly
• Interventions: Drug: fentanyl; Drug: dexmedetomidine; Drug: Ropivacaine

• Registration Number: NCT02375191
• Lead Sponsor: Yonsei University

Brief Summary

The purpose of this study is to evaluate the effect of epidural dexmedetomidine added to ropivacaine in pediatric orthopedic surgery

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-02-24
• Study First Submitted QC: 2015-02-27
• Study First Posted: 2015-03-02
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-16
• Last Update Posted: 2016-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

• pediatric patients aged from 3 to 12 years undergoing orthopedic mechanical correction surgery

Exclusion Criteria

• coagulopathy, refusal (parents), current infection on the lumbar area, spinal tract pathology

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
fentanyl	fentanyl	0.2% ropivacaine+ 1 mcg/kg fentanyl
dexmedetomidine	Ropivacaine	0.2% ropivacaine+1 mcg/kg dexmedetomidine
dexmedetomidine	dexmedetomidine	0.2% ropivacaine+1 mcg/kg dexmedetomidine
fentanyl	Ropivacaine	0.2% ropivacaine+ 1 mcg/kg fentanyl

Primary Outcome Measures

Name	Time	Method
Postoperative pain score	During 48 hrs after pediatric orthopedic surgery	CHEOPS, FLACC score were measured

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of