KETOR: Effects of Peri Operative Administration of Ketamine on Long Term Post Thoracotomy Pain

This study has been completed.

First Received on September 16, 2005. Last Updated on April 12, 2006 History of Changes

Sponsor:	Assistance Publique - Hôpitaux de Paris
Collaborators:	Direction Régionale de la Recherche Clinique D'ILE DE FRANCE Clinical Research Unit European Georges Pompidou Hospital
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00224588

Purpose

We assessed the effects of the N Methyl aspartate receptor antagonist Ketamine on long-term post thoracotomy pain. We hypothesized that ketamine could prevent supersensitization of the central nervous system involved in this chronic neuropathic pain.

Condition	Intervention	Phase
Ketamine Chronic Post Thoracotomy Pain Thoracotomy Pain Neuralgia	Drug: Ketamine (or placebo : isotonic saline solution)	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Effects of Peri Operative Administration of Ketamine on Long Term Post Thoracotomy Pain

Resource links provided by NLM:

Drug Information available for: Ketamine hydrochloride Ketamine

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:

Long term (2 months) post thoracotomy pain was assessed using a french equivalent of the Mc Gill Pain score and pain area measurements in both groups

Secondary Outcome Measures:

Analogic pain scores at rest and after coughing

Estimated Enrollment:	80
Study Start Date:	January 2003
Estimated Study Completion Date:	May 2005

Detailed Description:

In this clinical, randomized prospective study, peri operative administration of ketamine was compared to placebo on long term post thoracotomy pain after a 2 months follow up period.

Eligibility

Ages Eligible for Study:	80 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients eligible for thoracotomy or pneumectomy

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00224588

Locations

France
Georges Pompidou European Hospital
Paris, Ile de France, France, 75015

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Direction Régionale de la Recherche Clinique D'ILE DE FRANCE

Clinical Research Unit

European Georges Pompidou Hospital

Investigators

Principal Investigator:

Thierry GUENOUN, MD

Assistance Publique - Hôpitaux de Paris

More Information

Publications:

Frappier J, Guenoun T, Journois D, Philippe H, Aka E, Cadi P, Silleran-Chassany J, Safran D. Airway management using the intubating laryngeal mask airway for the morbidly obese patient. Anesth Analg. 2003 May;96(5):1510-5, table of contents.

ClinicalTrials.gov Identifier:	NCT00224588 History of Changes
Other Study ID Numbers:	P990911, CRC99029
Study First Received:	September 16, 2005
Last Updated:	April 12, 2006
Health Authority:	France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Ketamine
Chronic post thoracotomy pain
NMDA
Post operative

Additional relevant MeSH terms:

Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
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 February 12, 2012