Trial | NCT00672347  Report issue

Title

Clonidine and Morphine in Caudal Anesthesia
Comparison of Clonidine and Morphine Plus Bupivacaine in Caudal Peridural Anesthesia for Postoperative Analgesia After Pediatric Urogenital Surgery

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    80
Hypothesis: The combined use of Clonidine and Morphine in caudal anesthesia provides better postoperative analgesia than either drug alone after urogenital pediatric surgery.
It is a randomized, double blind study, involving 80 children with ages from 1 to 10 years old, submitted to urogenital surgery, under general anesthesia and caudal block. The patients will be divided into 4 groups: bupivacaine alone, bupivacaine plus clonidine, bupivacaine plus morphine, bupivacaine plus clonidine and morphine. The peroperative consumption of analgesics and inhaled gases, BIS, heart rate and arterial blood pressure will be recorded. Postoperative pain will be evaluated by using Wong-Baker faces scale and pain and discomfort score scale, as well as the consumption of analgesics.
Study Started
Jul 31
2008
Primary Completion
Sep 30
2008
Study Completion
Sep 30
2009
Last Update
Mar 19
2010
Estimate

Drug Clonidine

1 mcg/kg

Drug Morphine

20 mcg/kg

Drug Bupivacaine plus clonidine and morphine

bupivacaine 0,166% 1 ml/kg clonidine 1 mcg/kg morphine 20 mcg/kg

Drug Bupivacaine

Caudal anesthesia with bupivacaine 0,166% 1 ml/kg

B Active Comparator

compare caudal anesthesia with bupivacaine alone or in addition to morphine, clonidine or both

C Active Comparator

compare caudal anesthesia with bupivacaine plus clonidine with caudal anesthesia with bupivacaine alone or in addition to morphine or morphine plus clonidine

M Active Comparator

compare caudal anesthesia with bupivacaine plus morphine with caudal anesthesia with bupivacaine alone or in addition to clonidine or morphine plus clonidine

CM Active Comparator

compares caudal anesthesia with bupivacaine, morphine and clonidine with caudal anesthesia with bupivacaine alone or in addition to morphine or clonidine

Criteria 

Inclusion Criteria:

Urogenital pediatric surgery
Status physical(ASA) 1 and 2

Exclusion Criteria:

Cutaneous infection in puncture site
No Results Posted