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

This study has been completed.

First Received: September 16, 2005 Last Updated: 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:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
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, Ile De 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.

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

Anesthetics, Intravenous
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neuralgia
Physiological Effects of Drugs
Nervous System Diseases
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Agents
Pain
Pharmacologic Actions
Anesthetics, Dissociative

Signs and Symptoms
Neuromuscular Diseases
Sensory System Agents
Anesthetics, General
Therapeutic Uses
Peripheral Nervous System Diseases
Ketamine
Neurologic Manifestations
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Excitatory Amino Acid Antagonists

ClinicalTrials.gov processed this record on November 27, 2009