Hypothesis: The combined use of Clonidine and Morphine in caudal anesthesia provides better postoperative analgesia than either drug alone after urogenital pediatric surgery...
Date First Received: May 2, 2008
Last Updated: March 18, 2010
Verified by: Federal University of Minas Gerais, March 2010
Clinical Trial Phase: Phase 1/Phase 2 | Start Date: July 2008
Overall Status: Completed
Estimated Enrollment: 80
Brief Summary
Official Title: “Comparison of Clonidine and Morphine Plus Bupivacaine in Caudal Peridural Anesthesia for Postoperative Analgesia After Pediatric Urogenital Surgery”
Condition Keyword(s):
Additional Keyword(s) Provided by Sponsor:
Intervention(s):
Condition MeSH Term(s), Assigned with an Experimental Algorithm:
Intervention MeSH Term(s), Assigned with an Experimental Algorithm:
Hypothesis: The combined use of Clonidine and Morphine in caudal anesthesia provides better postoperative analgesia than either drug alone after urogenital pediatric surgery.
Study Type: Interventional
Study Design: Allocation: Randomized, Control: Dose Comparison, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Study Primary Completion Date: September 2008
Detailed Clinical Trial 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.
Intervention(s) in this Clinical Trial
- 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
Arms, Groups and Cohorts in this Clinical Trial
- Active Comparator: B
- compare caudal anesthesia with bupivacaine alone or in addition to morphine, clonidine or both
- Active Comparator: C
- compare caudal anesthesia with bupivacaine plus clonidine with caudal anesthesia with bupivacaine alone or in addition to morphine or morphine plus clonidine
- Active Comparator: M
- compare caudal anesthesia with bupivacaine plus morphine with caudal anesthesia with bupivacaine alone or in addition to clonidine or morphine plus clonidine
- Active Comparator: CM
- compares caudal anesthesia with bupivacaine, morphine and clonidine with caudal anesthesia with bupivacaine alone or in addition to morphine or clonidine
Outcome Measures for this Clinical Trial
Primary Measures
- The overall postoperative consumption of analgesics.
- Time Frame: 24 hours
Safety Issue?: Yes
- Time Frame: 24 hours
Secondary Measures
- The peroperative consumption of volatile anesthetics.
- Time Frame: 3 hours
Safety Issue?: Yes
- Time Frame: 3 hours
- The peroperative Bispectral Index measure.
- Time Frame: 3 hours
Safety Issue?: Yes
- Time Frame: 3 hours
- Postoperative Wong-Baker faces scale
- Time Frame: 24 hours
Safety Issue?: Yes
- Time Frame: 24 hours
- Postoperative pain and discomfort score scale
- Time Frame: 24 hours
Safety Issue?: Yes
- Time Frame: 24 hours
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Urogenital pediatric surgery
- Status physical(ASA) 1 and 2
Exclusion Criteria:
- Cutaneous infection in puncture site
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 1 Year
Maximum Age for this Clinical Trial: 10 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Federal University of Minas Gerais
Overall Clinical Trial Officials and Contacts
Renato S Gomez, PhD, MD Study Director Federal University of Minas Gerais
Related Publications
References
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.
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.
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.
Additional Information
Information obtained from ClinicalTrials.gov on September 02, 2010
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00672347
Study ID Number: 210665
ClinicalTrials.gov Identifier: NCT00672347
Health Authority: Brazil: National Health Surveillance Agency
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