Clonidine and Morphine in Caudal Anesthesia
Information source: Federal University of Minas Gerais
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postoperative Pain
Intervention: Clonidine (Drug); Morphine (Drug); Bupivacaine plus clonidine and morphine (Drug); Bupivacaine (Drug)
Phase: Phase 1/Phase 2
Status: Recruiting
Sponsored by: Federal University of Minas Gerais Official(s) and/or principal investigator(s):
Renato S Gomez, PhD, MD, Study Director, Affiliation: Federal University of Minas Gerais
Magda L Fernandes, M, Principal Investigator, Affiliation: Federal University of Minas Gerais
Overall contact:
Magda L Fernandes, Phone: 55-31-9227-7211, Email: balourenco@htomail.com
Summary
Hypothesis: The combined use of Clonidine and Morphine in caudal anesthesia provides better
postoperative analgesia than either drug alone after urogenital pediatric surgery.
Clinical Details
Official title: Comparison of Clonidine and Morphine Plus Bupivacaine in Caudal Peridural Anesthesia for Postoperative Analgesia After Pediatric Urogenital Surgery
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Dose Comparison, Parallel Assignment, Efficacy Study
Primary outcome: The overall postoperative consumption of analgesics.
Secondary outcome: The peroperative consumption of volatile anesthetics.The peroperative Bispectral Index measure. Postoperative Wong-Baker faces scale Postoperative pain and discomfort score scale
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
Minimum age: 1 Year.
Maximum age: 10 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Urogenital pediatric surgery
- Status physical(ASA) 1 and 2
Exclusion Criteria:
- Cutaneous infection in puncture site
Locations and Contacts
Magda L Fernandes, Phone: 55-31-9227-7211, Email: balourenco@htomail.com
Santa Casa de Belo Horizonte Hospital, Belo Horizonte, Minas Gerais, Brazil; Recruiting
Magda L Fernandes, Phone: 31-92277211, Email: balourenco@hotmail.com
Kleber CC Pires, Phone: 31-92073493, Email: k.cpires@terra.com.br
Kleber CC Pires, Sub-Investigator
Márcia RN Issa, Sub-Investigator
Moacir A Tibúrcio, Sub-Investigator
Additional Information
Related publications: 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.
Starting date: November 2008
Ending date: December 2009
Last updated: November 17, 2008
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