Clonidine and Morphine in Caudal Anesthesia

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00672347
• Other study ID #: 210665
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: May 2, 2008
• Last updated: March 18, 2010
• Start date: July 2008
• Est. completion date: September 2009

Study information

• Verified date: March 2010
• Source: Federal University of Minas Gerais
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 2009
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 10 Years

Eligibility

Inclusion Criteria:

• Urogenital pediatric surgery

• Status physical(ASA) 1 and 2

Exclusion Criteria:

• Cutaneous infection in puncture site

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Clonidine
1 mcg/kg
• Morphine
20 mcg/kg
• Bupivacaine plus clonidine and morphine
bupivacaine 0,166% 1 ml/kg clonidine 1 mcg/kg morphine 20 mcg/kg
• Bupivacaine
Caudal anesthesia with bupivacaine 0,166% 1 ml/kg

Locations

Country	Name	City	State
Brazil	Santa Casa de Belo Horizonte Hospital	Belo Horizonte	Minas Gerais

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of Minas Gerais	Santa Casa de Misericórdia de Belo Horizonte

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The overall postoperative consumption of analgesics.		24 hours	Yes
Secondary	The peroperative consumption of volatile anesthetics.		3 hours	Yes
Secondary	The peroperative Bispectral Index measure.		3 hours	Yes
Secondary	Postoperative Wong-Baker faces scale		24 hours	Yes
Secondary	Postoperative pain and discomfort score scale		24 hours	Yes