Clonidine and Morphine in Caudal Anesthesia

Federal University of Minas Gerais

Status and phase: Completed; Phase 2; Phase 1

Conditions: Postoperative Pain

Treatments: Drug: Bupivacaine; Drug: Morphine; Drug: Clonidine; Drug: Bupivacaine plus clonidine and morphine

Study type: Interventional

Funder types: Other

Identifiers

NCT00672347

210665

Details and patient eligibility

About

Hypothesis: The combined use of Clonidine and Morphine in caudal anesthesia provides better postoperative analgesia than either drug alone after urogenital pediatric surgery.

Full description

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.

Enrollment: 80 patients

Sex: All

Ages: 1 to 10 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Urogenital pediatric surgery
• Status physical(ASA) 1 and 2

Exclusion criteria

• Cutaneous infection in puncture site

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 4 patient groups

B

Active Comparator group

Description:

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

Treatment:

Drug: Bupivacaine

C

Active Comparator group

Description:

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

Treatment:

Drug: Clonidine

M

Active Comparator group

Description:

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

Treatment:

Drug: Morphine

CM

Active Comparator group

Description:

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

Treatment:

Drug: Bupivacaine plus clonidine and morphine