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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00224588
First Posted: September 23, 2005
Last Update Posted: April 13, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
  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 3

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

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   80 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients eligible for thoracotomy or pneumectomy

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
ClinicalTrials.gov Identifier: NCT00224588     History of Changes
Other Study ID Numbers: P990911
CRC99029
First Submitted: September 16, 2005
First Posted: September 23, 2005
Last Update Posted: April 13, 2006
Last Verified: September 2005

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
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action