• Overview
  • Eligibility
  • More info
  • Locations

Association of Different Doses of Clonidine in Caudal Epidural Anesthesia for Hypospadias Surgery (NCT02769390)

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.
  • 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
    • Atensine
  • 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
    • Atensine
  • 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
    • Atensine
Ages eligible for Study
1 Years to 10 Years
Genders eligible for Study
Male
Accepts Healthy Volunteers
No
Inclusion Criteria:
  • CHildren 1 - 10 years old.
  • ASA I E II ( American Society of Anesthesiology)
  • hypospadias surgery
Exclusion Criteria:
  • parents refuse
  • Infection
  • Coagulation disorders
  • Allergy to anesthetics
  • Abnormalities of the sacral spine
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.
Status:
unknown
Type:
Interventional
Phase:
Start:
30 June, 2015
Updated:
11 May, 2016
Participants:
80
A girl giving information about available additional trials.

FindMeCure helps you find, understand and join clinical trials from all over the world.

There are more clinical trials for your condition!