Non Opioid Treatment for Experimental Dyspnea (Nefopel)

Assistance Publique - Hôpitaux de Paris

Status and phase

Completed

Phase 3

Conditions

Dyspnea

Pain

Treatments

Drug: Nefopam

Study type

Interventional

Funder types

Other

Identifiers

NCT01577407

P 110103

Details and patient eligibility

About

The purpose of this protocol is to test the effects of the non opioid nefopam on experimental dyspnea and on the counterirritation (ie inhibition of one pain by another pain) induced by dyspnea in healthy subjects.

Full description

Dyspnea and pain share many features. One of them is the counterirritation phenomenon: defined in pain research as the attenuation of one pain by another pain. Dyspnea induced with inspiratory threshold loading (increased sense of work/effort ) has been shown to attenuate electrical pain as shown through nociceptive flexion reflex inhibition, or thermal pain, as measured with cortical evoked responses (laser evoked potentials-LEP).

The investigators will study whether nefopam modulates the counterirritation of laboratory induced dyspnea in healthy subjects. The effect of nefopam on experimental dyspnea will be measured with a visual analog scale (VAS) and a validated multidimensional dyspnea profile (MDP). The effect of treatment on counterirritation will be measured by recording LEP obtained using a CO2 laser system. The amplitude of the N2-P2 component of the LEP is the main study outcome.

Enrollment

15 patients

Sex

Male

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy
Non-smoking

Exclusion criteria

acute or chronic pain
antalgic or psychoactive drugs use
nefopam hypersensibility
severe allergy
diabetes
glaucoma
prostate adenoma
seizure disorder or convulsion history
heart or circulation disease
pulmonary disease or asthma
kidney or liver disease
brain or nerve disease
lack of adhesion to no antalgic drug, alcohol, coffee and cola within previous experiment day consumption