Tramadol and Pain Sensitization (TRAMADOL)

Tramadol — Thu, 23 Oct 2008 03:55:44 +0000

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:

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

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Tramadol and Pain Sensitization (TRAMADOL)