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Completed

NCT Number: NCT01577407

Non Opioid Treatment for Experimental Dyspnea

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.

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Key information

Conditions

Dyspnea Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Pitié salpetriere Hospital

Paris, 75013, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Nefopam

Drug

Subjects will be infused intravenously with nefopam (20mg/2mL) over a course of 30 minutes in a supine position. There will be a single administration of IV 20 mg nefopam and IV placebo. Each intervention will occur on a separate day.

Other names: acupan

Primary outcomes

  1. variation of N2-P2 (components of laser evoked potential - tool of pain measurement)amplitude with inspiratory loading induced by intervention

    Time frame: Change from baseline to 1 hour and half from intervention

    LEP will be recorded before intervention at baseline and after intervention at baseline, during inspiratory loading and recovery. The outcome is the variation of N2-P2 amplitude with inspiratory loading induced by intervention

Secondary outcomes

  1. variation of subject rating of breathing discomfort (dyspnea)

    Time frame: Change from baseline to 1 hour and half from intervention

    repeated measurement on VAS (visual analog scale)

  2. variation of N20-P25 amplitude (components of somesthesic evoked potential (SEP) -measurement of sensitivity)

    Time frame: Change from baseline to 1 hour and half from intervention

    SEP will be recorded before intervention at baseline and after intervention at baseline, during inspiratory loading. This is a methodological control

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: Nefopel

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Apr 13, 2012
Registry last updated
Dec 11, 2012

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.

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