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

Last updated: May 12, 2016
Sponsor: Federal University of Minas Gerais
Overall Status: Completed

Phase

2

Condition

Post-surgical Pain

Chronic Pain

Pain

Treatment

N/A

Clinical Study ID

NCT02769390
CAAE23332313600005149
  • Ages 1-10
  • Male

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • CHildren 1 - 10 years old.

  • ASA I E II ( American Society of Anesthesiology)

  • hypospadias surgery

Exclusion

Exclusion Criteria:

  • parents refuse

  • Infection

  • Coagulation disorders

  • Allergy to anesthetics

  • Abnormalities of the sacral spine

Study Design

Total Participants: 80
Study Start date:
July 01, 2015
Estimated Completion Date:
November 30, 2015

Study Description

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. Postoperative hemodynamics parameters will be recordes at 24 h.