Clonidine and Morphine in Caudal Anesthesia - Full Text View

Sponsor:	Federal University of Minas Gerais
Collaborator:	Santa Casa de Belo Horizonte
Information provided by:	Federal University of Minas Gerais
ClinicalTrials.gov Identifier:	NCT00672347

Purpose

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

Condition	Intervention	Phase
Postoperative Pain	Drug: Clonidine Drug: Morphine Drug: Bupivacaine plus clonidine and morphine Drug: Bupivacaine	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Dose Comparison, Parallel Assignment, Efficacy Study
Official Title:	Comparison of Clonidine and Morphine Plus Bupivacaine in Caudal Peridural Anesthesia for Postoperative Analgesia After Pediatric Urogenital Surgery

Resource links provided by NLM:

MedlinePlus related topics: Anesthesia Surgery

Drug Information available for: Bupivacaine hydrochloride Bupivacaine Clonidine Clonidine hydrochloride

U.S. FDA Resources

Further study details as provided by Federal University of Minas Gerais:

Primary Outcome Measures:

The overall postoperative consumption of analgesics. [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The peroperative consumption of volatile anesthetics. [ Time Frame: 3 hours ] [ Designated as safety issue: Yes ]
The peroperative Bispectral Index measure. [ Time Frame: 3 hours ] [ Designated as safety issue: Yes ]
Postoperative Wong-Baker faces scale [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
Postoperative pain and discomfort score scale [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	80
Study Start Date:	November 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
B: Active Comparator Caudal anesthesia with bupivacaine	Drug: Bupivacaine Caudal anesthesia with bupivacaine 0,166% 1 ml/kg
C: Active Comparator Caudal anesthesia with bupivacaine plus clonidine	Drug: Clonidine 1 mcg/kg
M: Active Comparator Caudal anesthesia with bupivacaine plus Morphine	Drug: Morphine 20 mcg/kg
CM: Active Comparator Caudal anesthesia with bupivacaine plus Clonidine and Morphine	Drug: Bupivacaine plus clonidine and morphine bupivacaine 0,166% 1 ml/kg clonidine 1 mcg/kg morphine 20 mcg/kg

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

Ages Eligible for Study:	1 Year to 10 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Urogenital pediatric surgery
Status physical(ASA) 1 and 2

Exclusion Criteria:

Cutaneous infection in puncture site

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00672347

Contacts

Contact: Magda L Fernandes

55-31-9227-7211

balourenco@htomail.com

Locations

Brazil, Minas Gerais
Santa Casa de Belo Horizonte Hospital	Recruiting
Belo Horizonte, Minas Gerais, Brazil
Contact: Magda L Fernandes 31-92277211 balourenco@hotmail.com
Contact: Kleber CC Pires 31-92073493 k.cpires@terra.com.br
Sub-Investigator: Kleber CC Pires
Sub-Investigator: Márcia RN Issa
Sub-Investigator: Moacir A Tibúrcio

Sponsors and Collaborators

Federal University of Minas Gerais

Santa Casa de Belo Horizonte

Investigators

Study Director:	Renato S Gomez, PhD, MD	Federal University of Minas Gerais
Principal Investigator:	Magda L Fernandes, M	Federal University of Minas Gerais

More Information

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.

Responsible Party:	Federal University of Minas Gerais ( Renato Santiago Gomez - PhD,MD )
Study ID Numbers:	210665
Study First Received:	May 2, 2008
Last Updated:	November 17, 2008
ClinicalTrials.gov Identifier:	NCT00672347 History of Changes
Health Authority:	Brazil: National Health Surveillance Agency

Keywords provided by Federal University of Minas Gerais:

caudal anesthesia, clonidine, morphine, bupivacaine

Additional relevant MeSH terms:

Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anesthetics
Pain
Adrenergic Agonists
Signs and Symptoms
Pathologic Processes
Sensory System Agents
Therapeutic Uses
Analgesics
Analgesics, Opioid
Pain, Postoperative
Morphine

Sympatholytics
Adrenergic alpha-Agonists
Clonidine
Central Nervous System Depressants
Narcotics
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Anesthetics, Local
Postoperative Complications
Autonomic Agents
Bupivacaine
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010