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

This study has been completed.
Information provided by:
Institut Bergonié Identifier:
First received: September 13, 2005
Last updated: July 25, 2013
Last verified: October 2007
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:

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

Enrollment: 230
Study Start Date: February 2004
Study Completion Date: December 2005

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00210210

Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest
Bordeaux, France, 33076
Sponsors and Collaborators
Institut Bergonié
Principal Investigator: Sylvie COLOMBANI, MD Institut Bergonié
  More Information Identifier: NCT00210210     History of Changes
Other Study ID Numbers: IB2004-04  KETAMINE 
Study First Received: September 13, 2005
Last Updated: July 25, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Institut Bergonié:
Breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Pain, Postoperative
Neoplasms by Site
Breast Diseases
Skin Diseases
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action processed this record on October 21, 2016