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

This study has been completed.

Sponsor:

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

First received: September 16, 2005

Last updated: April 12, 2006

Last verified: September 2005

History of Changes

Tracking Information

First Received Date ^ICMJE

September 16, 2005

Last Updated Date

April 12, 2006

Start Date ^ICMJE

January 2003

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00224588 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Analogic pain scores at rest and after coughing

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Ketamine
Chronic Post Thoracotomy Pain
Thoracotomy
Pain
Neuralgia

Intervention ^ICMJE

Drug: Ketamine (or placebo : isotonic saline solution)

Study Arms

Not Provided

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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Estimated Completion Date

May 2005

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients eligible for thoracotomy or pneumectomy

Exclusion Criteria:

Sex/Gender

Sexes Eligible for Study:

All

Ages

80 Years and older (Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

France

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00224588

Other Study ID Numbers ^ICMJE

P990911
CRC99029

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Assistance Publique - Hôpitaux de Paris

Collaborators ^ICMJE

Direction Régionale de la Recherche Clinique D'ILE DE FRANCE
Clinical Research Unit
European Georges Pompidou Hospital

Investigators ^ICMJE

Principal Investigator:

Thierry GUENOUN, MD

Assistance Publique - Hôpitaux de Paris

PRS Account

Assistance Publique - Hôpitaux de Paris

Verification Date

September 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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