NCT00224588

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 23, 2005

Completed
Last Updated

April 13, 2006

Status Verified

September 1, 2005

First QC Date

September 16, 2005

Last Update Submit

April 12, 2006

Conditions

KetamineChronic Post Thoracotomy PainThoracotomyPainNeuralgia

Keywords

KetamineChronic post thoracotomy painNMDAPost operative

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Analogic pain scores at rest and after coughing

Interventions

Ketamine (or placebo : isotonic saline solution)DRUG

Eligibility Criteria

Age80 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Patients eligible for thoracotomy or pneumectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Georges Pompidou European Hospital

Paris, Île-de-France Region, 75015, France

Location

Related 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):1510-1515. doi: 10.1213/01.ANE.0000057003.91393.3C.

    PMID: 12707159BACKGROUND

MeSH Terms

Conditions

PainNeuralgia

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Thierry GUENOUN, MD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 16, 2005

First Posted

September 23, 2005

Study Start

January 1, 2003

Study Completion

May 1, 2005

Last Updated

April 13, 2006

Record last verified: 2005-09

Locations

FR(1)