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Administration of Ketamine to Prevent the Post-operative Pain (KETAMINE)

This study has been completed.
Sponsor:
Information provided by:
Institut Bergonié
ClinicalTrials.gov Identifier:
NCT00210210
First received: September 13, 2005
Last updated: December 29, 2011
Last verified: October 2007
History of Changes
  Purpose

The surgery of breast cancer is responsible for post-operative pain, needing in about 30% some morphine consumption; like that, the association of ketamine with general anaesthesia may decrease morphine's use and so its adverse effects. The purpose is to evaluate the analgesic effect of a receptor NMDA's antagonist ( ketamine)


Condition Intervention Phase
Postoperative Pain
Breast Cancer
 Drug: Ketamine
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Effect of Ketamine, at the Induction and Its Maintenance to Prevent the Post-operative Pain: Clinical Trial in Cancerology

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Institut Bergonié:

Primary Outcome Measures:
  • Morphine consumption (first 48 post-operative hours)

Secondary Outcome Measures:
  • Visual analog rating scale during the first 48 post-operative hours: at 15mn,1H,2H,12H, 24H,36H,48H

Estimated Enrollment: 220
Study Start Date: February 2004
Study Completion Date: December 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Patients 18 years older
  • ASA class 1 or 2
  • with surgery of breast cancer (mastectomy or tumorectomy)

Exclusion criteria:

.Kétamine hypersensitivity

  • Major psychiatric disorders
  • Major cardio-vascular disorders
  • Major neurologic disorders
  • Major ocular disorders
  • Morphine in pre-operative period
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00210210

Locations
France
Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest
Bordeaux, France, 33076
Sponsors and Collaborators
Institut Bergonié
Investigators
Principal Investigator: Sylvie COLOMBANI, MD Institut Bergonié
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00210210     History of Changes
Other Study ID Numbers: IB2004-04, KETAMINE
Study First Received: September 13, 2005
Last Updated: December 29, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Institut Bergonié:
Post-operative-pain
Breast cancer
Morphine
Analgesia

Additional relevant MeSH terms:
Breast Neoplasms
Pain, Postoperative
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Ketamine
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
 Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on May 16, 2013