Clonidine and Morphine in Caudal Anesthesia - Full Text View

Sponsor:	Federal University of Minas Gerais
Collaborator:	Santa Casa de Misericórdia 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:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
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:

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 ]

Enrollment:	80
Study Start Date:	July 2008
Study Completion Date:	September 2009
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: B compare caudal anesthesia with bupivacaine alone or in addition to morphine, clonidine or both	Drug: Bupivacaine Caudal anesthesia with bupivacaine 0,166% 1 ml/kg
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	Drug: Clonidine 1 mcg/kg
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	Drug: Morphine 20 mcg/kg
Active Comparator: CM compares caudal anesthesia with bupivacaine, morphine and clonidine with caudal anesthesia with bupivacaine alone or in addition to morphine or clonidine	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

Locations

Brazil
Santa Casa de Belo Horizonte Hospital
Belo Horizonte, Minas Gerais, Brazil

Sponsors and Collaborators

Federal University of Minas Gerais

Santa Casa de Misericórdia 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:	Renato Santiago Gomez - PhD,MD, Federal University of Minas Gerais
ClinicalTrials.gov Identifier:	NCT00672347 History of Changes
Other Study ID Numbers:	210665
Study First Received:	May 2, 2008
Last Updated:	March 18, 2010
Health Authority:	Brazil: National Health Surveillance Agency

Keywords provided by Federal University of Minas Gerais:

caudal anesthesia, clonidine, morphine, bupivacaine

Additional relevant MeSH terms:

Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Anesthetics
Bupivacaine
Clonidine
Morphine
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Local

Sensory System Agents
Peripheral Nervous System Agents
Antihypertensive Agents
Cardiovascular Agents
Sympatholytics
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics
Analgesics, Opioid
Narcotics

ClinicalTrials.gov processed this record on February 09, 2012