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Clonidine and Morphine in Caudal Anesthesia

Information source: Federal University of Minas Gerais
ClinicalTrials.gov processed this data on August 20, 2015
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: Completed

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


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

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.


Minimum age: 1 Year. Maximum age: 10 Years. Gender(s): Both.


Inclusion Criteria:

- Urogenital pediatric surgery

- Status physical(ASA) 1 and 2

Exclusion Criteria:

- Cutaneous infection in puncture site

Locations and Contacts

Santa Casa de Belo Horizonte Hospital, Belo Horizonte, Minas Gerais, Brazil
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: July 2008
Last updated: March 18, 2010

Page last updated: August 20, 2015

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