Purpose
Tramadol is a largely used analgesic drug. Its role however on sensitization as occurs for example in neuropathic pain is not very well known. This protocol aims therefore at studying the effect of tramadol in a human pain model with sensitization induced by a cold stimulus, using evoked potentials to elucidate how pain is modified when tramadol is administered.
| Condition | Intervention | Phase |
| Pain | Drug: Tramadol | Phase I |
| Drug Information available for: | Tramadol hydrochloride Tramadol |
U.S. FDA Resources
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Pharmacodynamics Study |
| Official Title: | Tramadol and Pain Sensitization |
Further study details as provided by University Hospital, Clermont-Ferrand:
Primary Outcome Measures:
- Amplitude of the evoked potential elicited by a thermal stimulus on the arm with an induced hyperalgic area [ Time Frame: with an induced hyperalgic area ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 12 |
| Study Start Date: | September 2007 |
| Estimated Study Completion Date: | December 2007 |
| Estimated Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Intervention Details:
- Drug: Tramadol
to compare of the analgesic of tramadol versus placebo in a pain model using evoked potentials
Detailed Description:
The study is a comparison of the analgesic of tramadol versus placebo in a pain model using evoked potentials. Evaluation criteria will be the amplitude of the evoked potential obtained defore and after treatment
