Administration of Ketamine to Prevent the Post-Operative Pain - Full Text View

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 III

Genetics Home Reference related topics:

breast cancer

MedlinePlus related topics:

Breast Cancer Cancer

ChemIDplus related topics:

Ketamine Ketamine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Official Title:	Effect of Ketamine, at the Induction and Its Maintenance to Prevent the Post-Operative Pain: Clinical Trial in Cancerology

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

Study ID Numbers:	IB2004-04, KETAMINE
First Received:	September 13, 2005
Last Updated:	October 31, 2007
ClinicalTrials.gov Identifier:	NCT00210210
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Institut Bergonié:

Post-operative-pain

Breast cancer

Morphine

Analgesia

Study placed in the following topic categories:

Excitatory Amino Acids

Morphine

Signs and Symptoms

Postoperative Complications

Skin Diseases

Ketamine

Breast Neoplasms

Pain

Breast Diseases

Pain, Postoperative

Additional relevant MeSH terms:

Anesthetics, Intravenous

Neurotransmitter Agents

Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs

Anesthetics

Central Nervous System Depressants

Excitatory Amino Acid Agents

Anesthetics, Dissociative

Pharmacologic Actions

Neoplasms

Neoplasms by Site

Pathologic Processes

Sensory System Agents

Anesthetics, General

Therapeutic Uses

Peripheral Nervous System Agents

Analgesics

Central Nervous System Agents

Excitatory Amino Acid Antagonists

ClinicalTrials.gov processed this record on October 03, 2008

Sponsored by:	Institut Bergonié
Information provided by:	Institut Bergonié
ClinicalTrials.gov Identifier:	NCT00210210