Clonidine and Morphine in Caudal Anesthesia

This study has been completed.
Sponsor:
Collaborator:
Santa Casa de Misericórdia de Belo Horizonte
Information provided by:
Federal University of Minas Gerais
ClinicalTrials.gov Identifier:
NCT00672347
First received: May 2, 2008
Last updated: March 18, 2010
Last verified: March 2010
  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 1
Phase 2

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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
Morphine
Clonidine
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Local
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

ClinicalTrials.gov processed this record on October 19, 2014