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More info
You can access this
clinical trial
if you have
Postoperative Pain
and you are
between 1 and 10
years old
This is a second phase trial assessing
efficacy and side effects of the new treatment.
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The purpose

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.

Provided treatments

  • Drug: Clonidine 1 mcg/Kg
  • Drug: Clonidine 2 mcg/ Kg
  • Drug: Clonidine 3 mcg/ Kg
Tris trial is registered with FDA with number: NCT02769390. The sponsor of the trial is Federal University of Minas Gerais and it is looking for 80 volunteers for the current phase.
Official trial title:
Association of Different Doses of Clonidine in Caudal Epidural Anesthesia for Hypospadias Surgery