Status:
COMPLETED
Oral Ketamine Administration in Patients With Peripheral Neuropathic Pain
Lead Sponsor:
University Hospital, Toulouse
Conditions:
Neuropathic Pain
Eligibility:
All Genders
30-90 years
Phase:
PHASE2
Brief Summary
Nowadays, available drugs cannot always produce pain relief in patients with neuropathic pain disease. It is believed that drugs acting as antagonists of the N-methyl-D-aspartic acid (NMDA) receptor ...
Detailed Description
In previous studies, it was shown that when ketamine was administrated by the intravenous route, its analgesic action was rapid. In one study, when oral ketamine was administrated to patients sufferin...
Eligibility Criteria
Inclusion
- Patients must suffer from peripheral neuropathic chronic pain.
- Pain score must be at least 40 mm in a VAS (reflecting pain intensity during the 7 days and the day before visit 1).
- Patients in which pain is not satisfactory relieved by level 1, 2 or 3 analgesic drugs (associated or not with antidepressants or antiepileptic drugs). Patients treated with level 2 or 3 analgesic drugs must stop these treatments one week before and during ketamine treatment.
- Patients must benefit from the French Social security system.
- Patients must be able to complete the tests.
- Patients must give a written informed consent.
- Patients must be aged from 30 to 90 years.
- Female fertile patients must use an efficient method of contraception.
Exclusion
- Patients not suffering from peripheral neuropathic chronic pain.
- Pain score is less than 40 mm in a VAS (reflecting pain intensity during the 7 days and the day before visit 1).
- Patients not able to complete the tests.
- Patients not able to stop level 2 or 3 analgesic drugs.
- Patients in which ketamine is contraindicated:
- Hypersensibility to one of the compounds of the ketamine syrup
- Uncontrolled arterial hypertension
- Recent cardio vascular accident
- Severe cardiac problems
- Drug abuse
- Psychosis
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00961194
Start Date
March 1 2009
End Date
March 1 2014
Last Update
December 2 2014
Active Locations (1)
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1
Service de Neurochirurgie
Toulouse, France, 31059