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Association of Different Doses of Clonidine in Caudal Epidural Anesthesia for Hypospadias Surgery

NCT02769390 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2016-05-13

No results posted yet for this study

Summary

The use of increasing doses of clonidine ssociated to bupivacaine in caudal epidural block provides better postoperative analgesia compared whit analgesia provide by bupivacaine alone

It is a randomized, double blind study, involving 80 children with ages from 1 to 10 years old, following eletive hypospadias surgery, under general anesthesia and caudal epidural block . The patients will be divided into 4 groups: bupivacaine alone, bupivacaine plus clonidine 1mcg/kg, bupivacaine plus clonidine 2 mcg/kg, bupivacaine plus clonidine 3 mg/kg. The peroperative consumption of anesthetics gases, heart rate and arterial blood pressure will be recorded. Postoperative pain will be evaluated by using FLACC scale ( faces , legs, activity , cry , consolability ) . Requiriments for supplementary postoperative analgesia at 24 h will be avaiable.

Conditions

  • Postoperative Pain

Interventions

DRUG

Clonidine 1 mcg/Kg

Clonidine 1 mcg/Kg associated with bupivacaine 0,166% 1 ml/Kg administred epidural caudal in children for hypospadias surgery

DRUG

Clonidine 2 mcg/ Kg

Clonidine 2 mcg//Kg associated with bupivacaine 0,166% 1 ml/Kg administred epidural caudal in children for hypospadias surgery

DRUG

Clonidine 3 mcg/ Kg

Clonidine 3 mcg //Kg associated with bupivacaine 0,166% 1 ml/Kg administred epidural caudal in children for hypospadias surgery

Sponsors & Collaborators

  • Federal University of Minas Gerais

    lead OTHER

Principal Investigators

  • ana claudia mota bonisson, M · Hospital da Baleia - Fundação Benjamim Guimaraes

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
10 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2015-11-30
Completion
2015-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02769390 on ClinicalTrials.gov