Tramadol and Pain Sensitization (TRAMADOL)

University Hospital, Clermont-Ferrand

Status and phase: Completed; Phase 1

Conditions: Pain

Treatments: Drug: Tramadol

Study type: Interventional

Funder types: Other

Identifiers

NCT00487175

CHU63-0020

Details and patient eligibility

About

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.

Full 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

Enrollment: 12 estimated patients

Sex: Male

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy men
• Between 18 and 40 years old
• Written consent given

Exclusion criteria

• Concomitant medication
• Tramadol hypersensibility
• Excessive consumption of alcohol, tobacco, coffee, tea or toxicomania

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind