Clonidine and Morphine in Caudal Anesthesia

Phase 1

Completed

• Conditions: Postoperative Pain
• Interventions: Drug: Bupivacaine plus clonidine and morphine; Drug: Bupivacaine; Drug: Clonidine; Drug: Morphine

• Registration Number: NCT00672347
• Lead Sponsor: Federal University of Minas Gerais

Brief Summary

Hypothesis: The combined use of Clonidine and Morphine in caudal anesthesia provides better postoperative analgesia than either drug alone after urogenital pediatric surgery.

Detailed Description

It is a randomized, double blind study, involving 80 children with ages from 1 to 10 years old, submitted to urogenital surgery, under general anesthesia and caudal block. The patients will be divided into 4 groups: bupivacaine alone, bupivacaine plus clonidine, bupivacaine plus morphine, bupivacaine plus clonidine and morphine. The peroperative consumption of analgesics and inhaled gases, BIS, heart rate and arterial blood pressure will be recorded. Postoperative pain will be evaluated by using Wong-Baker faces scale and pain and discomfort score scale, as well as the consumption of analgesics.

Study Timeline

• Study First Submitted: 2008-05-02
• Study First Submitted QC: 2008-05-02
• Study First Posted: 2008-05-06
• Study Start: 2008-07
• Primary Completion: 2008-09
• Study Completion: 2009-09
• Status Verified: 2010-03
• Last Update Submitted: 2010-03-18
• Last Update Posted: 2010-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Urogenital pediatric surgery
• Status physical(ASA) 1 and 2

Exclusion Criteria

• Cutaneous infection in puncture site

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CM	Bupivacaine plus clonidine and morphine	compares caudal anesthesia with bupivacaine, morphine and clonidine with caudal anesthesia with bupivacaine alone or in addition to morphine or clonidine
B	Bupivacaine	compare caudal anesthesia with bupivacaine alone or in addition to morphine, clonidine or both
C	Clonidine	compare caudal anesthesia with bupivacaine plus clonidine with caudal anesthesia with bupivacaine alone or in addition to morphine or morphine plus clonidine
M	Morphine	compare caudal anesthesia with bupivacaine plus morphine with caudal anesthesia with bupivacaine alone or in addition to clonidine or morphine plus clonidine

Primary Outcome Measures

Name	Time	Method
The overall postoperative consumption of analgesics.	24 hours

Secondary Outcome Measures

Name	Time	Method
The peroperative consumption of volatile anesthetics.	3 hours
The peroperative Bispectral Index measure.	3 hours
Postoperative Wong-Baker faces scale	24 hours
Postoperative pain and discomfort score scale	24 hours

Trial Locations

Locations (1)

Santa Casa de Belo Horizonte Hospital; 🇧🇷 Belo Horizonte, Minas Gerais, Brazil