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Nefopel: Non Opioid Treatment for Experimental Dyspnea

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Completed
CT.gov ID
NCT01577407
Collaborator
(none)
15
Enrollment
1
Location
2
Arms
8
Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
15 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Non Opioid Treatment for Experimental Dyspnea
Study Start Date :
Sep 1, 2011
Actual Primary Completion Date :
May 1, 2012
Actual Study Completion Date :
May 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: Nefopam

Drug: Nefopam
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

    		•
    Placebo Comparator: placebo

    Drug: Nefopam
    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

    		•

    Outcome Measures

    Primary Outcome Measures

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

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pitié salpetriere Hospital Paris France 75013

    Sponsors and Collaborators

    • Assistance Publique - Hôpitaux de Paris

    Investigators

    • Principal Investigator: Capucine Morelot, MD, PhD, Assistance Publique - Hôpitaux de Paris

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Assistance Publique - Hôpitaux de Paris
    ClinicalTrials.gov Identifier:
    NCT01577407
    Other Study ID Numbers:
    • P 110103
    First Posted:
    Apr 13, 2012
    Last Update Posted:
    Dec 11, 2012
    Last Verified:
    Oct 1, 2011
    Keywords provided by Assistance Publique - Hôpitaux de Paris
    Dyspnea
    Pain
    Additional relevant MeSH terms:
    Dyspnea
    Nefopam

    Study Results

    No Results Posted as of Dec 11, 2012