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NCT00224588 Clinical Trial

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

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00224588
Other study ID # P990911
Secondary ID CRC99029
Status Completed
Phase Phase 3
First received September 16, 2005
Last updated April 12, 2006
Start date January 2003
Est. completion date May 2005

Study information
Verified date September 2005
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority France: Ministry of Health
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date May 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 80 Years and older
Eligibility Inclusion Criteria:

- Patients eligible for thoracotomy or pneumectomy

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Ketamine (or placebo : isotonic saline solution)

Locations
Country Name City State
France Georges Pompidou European Hospital Paris Ile de France

Sponsors (4)
Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris Clinical Research Unit, Direction Régionale de la Recherche Clinique D'ILE DE FRANCE, European Georges Pompidou Hospital

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Analogic pain scores at rest and after coughing
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