Tramadol and Pain Sensitization

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.

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Key information

Conditions

Pain Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

CIC

Clermont-Ferrand, 63000, France

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tramadol

Drug

to compare of the analgesic of tramadol versus placebo in a pain model using evoked potentials

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Acronym: TRAMADOL

Important dates

Study start: 2007
Primary completion: 2007
Study completion: 2008
First posted: Jun 15, 2007
Registry last updated: Mar 17, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed