Clinical trial NCT00672347: Clonidine and Morphine in Caudal Anesthesia
Official title: Comparison of Clonidine and Morphine Plus Bupivacaine in Caudal Peridural Anesthesia for Postoperative Analgesia After Pediatric Urogenital Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Postoperative Pain
Keywords: caudal anesthesia, clonidine, morphine, bupivacaine
Lead sponsor: Federal University of Minas Gerais
Sponsor class: OTHER
Collaborators: name: Santa Casa de Misericórdia de Belo Horizonte
First posted: 2008-05-06
Enrollment: 80
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Cutaneous infection in puncture site

Primary outcomes:
measure: The overall postoperative consumption of analgesics.
timeFrame: 24 hours
Secondary outcomes:
measure: The peroperative consumption of volatile anesthetics.
timeFrame: 3 hours
measure: The peroperative Bispectral Index measure.
timeFrame: 3 hours
measure: Postoperative Wong-Baker faces scale
timeFrame: 24 hours
measure: Postoperative pain and discomfort score scale
timeFrame: 24 hours
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: Santa Casa de Belo Horizonte Hospital
state: Minas Gerais
Study officials:
affiliation: Federal University of Minas Gerais
name: Renato S Gomez, PhD, MD
role: STUDY_DIRECTOR
affiliation: Federal University of Minas Gerais
name: Magda L Fernandes, M
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tripi PA, Palmer JS, Thomas S, Elder JS. Clonidine increases duration of bupivacaine caudal analgesia for ureteroneocystostomy: a double-blind prospective trial. J Urol. 2005 Sep;174(3):1081-3. doi: 10.1097/01.ju.0000169138.90628.b9.
citation: Luz G, Innerhofer P, Oswald E, Salner E, Hager J, Sparr H. Comparison of clonidine 1 microgram kg-1 with morphine 30 micrograms kg-1 for post-operative caudal analgesia in children. Eur J Anaesthesiol. 1999 Jan;16(1):42-6. doi: 10.1046/j.1365-2346.1999.00430.x.
citation: Vetter TR, Carvallo D, Johnson JL, Mazurek MS, Presson RG Jr. A comparison of single-dose caudal clonidine, morphine, or hydromorphone combined with ropivacaine in pediatric patients undergoing ureteral reimplantation. Anesth Analg. 2007 Jun;104(6):1356-63, table of contents. doi: 10.1213/01.ane.0000261521.52562.de.