drugset / Trial / NCT02769390

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

NCT02769390

Phase 2 Completed 80 enrolled Federal University of Minas Gerais
RandomizedParallel-groupQuadruple-blindSupportive care

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.

Timeline

Start
2015-07
Primary completion
2015-11
Completion
2015-11

Drugs

EvaluationDrugModalityDoseRoute
Comparator Clonidine Other / unclassified 1 ug/kg Other
Comparator Clonidine Other / unclassified 2 ug/kg Other
Comparator Clonidine Other / unclassified 3 ug/kg Other

Indications

No indication recorded.