Comparison of MEOPA + Paracetamol Versus Morphine Treatment in Acute Coronary Syndrome Analgesia.

Last updated: February 2, 2018
Sponsor: University Hospital, Toulouse
Overall Status: Completed

Phase

4

Condition

Myocardial Ischemia

Coronary Artery Disease

Cardiac Ischemia

Treatment

N/A

Clinical Study ID

NCT02198378
RC31/13/7050
13705001
  • Ages > 18
  • All Genders

Study Summary

In the management of acute coronary syndromes with ST-segment elevation (STEMI), early analgesia reduces the effects of hyperadrenalism which increases the size of myocardial infarction. In order to reduce pain intensity, the recommendations advocate emergency use of morphine. In STEMI patients, other analgesic treatments could provide analgesia that is at least as effective as morphine. The equimolar oxygen/nitrous oxide mixture (MEOPA) is widely used in emergency medicine and has minor secondary effects that are very rapidly reversible when inhalation is discontinued. Used in association with paracetamol, it could be an at least equally effective alternative to the use of morphine.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient with STEMI < 12 h treated before hospital admission and pain ≥ 4 on thenumerical rating scale.

Exclusion

Exclusion Criteria:

  • Acute severe hemodynamic, respiratory or neurological failure

  • Heart failure: Killip class III and IV

  • Known allergy to morphine or nitrous oxide

  • Patient who has already received morphine or MEOPA before the arrival of the hospitalteam during the 4 hours preceding the pre-hospital intervention

  • Contraindications to nitrous oxide

  • Patient unable to assess pain intensity on the numerical rating scale

  • Patient under legal guardianship

  • Pregnancy

  • Patient transported by air ambulance

Study Design

Total Participants: 680
Study Start date:
November 01, 2014
Estimated Completion Date:
January 31, 2017

Study Description

The investigators wish to compare the use of morphine according to current recommendations with the use of MEOPA associated with intravenous paracetamol in the management of patients with STEMI. The investigators hypothesize that the association of MEOPA and paracetamol, which is easy to use in a pre-hospital setting, will give patients pain relief as effectively as morphine.

This alternative treatment would avoid the use of morphine, whose potentially damaging consequences on myocardial function have been suggested by experimental studies and by an observational study. The physician of the mobile emergency team (SMUR) verifies the inclusion and non- inclusion criteria for the study. The patient must present STEMI defined in accordance with the recommendations and chest pain of intensity ≥ 4 on the NRS. The specific treatment for STEMI will be given before inclusion in the study, with the exception of analgesic treatment. In particular, inclusion in the study must not delay the initiation of strategies of recanalization and reperfusion.

The SMUR physician in charge of the patient will administer the treatment defined by randomization.

After 30 minutes, the patient will be managed in accordance with the recommendations and will be hospitalized, generally in a cardiology intensive care unit. At one month, the clinical research technician will record the patient's vital status and collect the patient's hospital records.

Connect with a study center

  • Centre Hospitalier d'Agen

    Agen,
    France

    Site Not Available

  • Centre Hospitalier Jean Minjoz

    Besançon,
    France

    Site Not Available

  • CHU Avicenne

    Bobigny,
    France

    Site Not Available

  • Hôpital Pellegrin

    Bordeaux,
    France

    Site Not Available

  • Centre Hospitalier Bourg-en-Bresse

    Bourg-en-Bresse,
    France

    Site Not Available

  • Centre Hospitalier de Chambéry

    Chambéry,
    France

    Site Not Available

  • Centre Hospitalier Louis Pasteur

    Chartres,
    France

    Site Not Available

  • Centre Hospitalier Chateauroux

    Chateauroux,
    France

    Site Not Available

  • CHU d'Estaing

    Clermont-Ferrand,
    France

    Site Not Available

  • Centre Hospitalier Beaujon

    Clichy,
    France

    Site Not Available

  • Centre Hospitalier Alpes Léman

    Contamine sur Arve,
    France

    Site Not Available

  • Centre Hospitalier Sud Francilien

    Corbeil-Essonnes,
    France

    Site Not Available

  • Centre Hospitalier Dijon

    Dijon,
    France

    Site Not Available

  • Centre Hospitalier du Val d'Ariège

    Foix,
    France

    Site Not Available

  • Centre Hospitalier Raymond Poincaré

    Garches,
    France

    Site Not Available

  • Centre Hospitalier de Grenoble

    Grenoble,
    France

    Site Not Available

  • Centre Hospitalier Départemental La Roche/Yon

    La Roche-sur-Yon,
    France

    Site Not Available

  • Centre Hospitalier Départemental La Roche/Yon

    La Roche/Yon,
    France

    Site Not Available

  • CHRU Lille

    Lille,
    France

    Site Not Available

  • CHU Dupuytren

    Limoges,
    France

    Site Not Available

  • Centre Hospitalier Edouard Herriot

    Lyon,
    France

    Site Not Available

  • Centre Hospitalier de la Timone

    Marseille,
    France

    Site Not Available

  • Centre Hospitalier Marc Jacquet

    Melun,
    France

    Site Not Available

  • CHR Bon Secours

    Metz,
    France

    Site Not Available

  • CHRU Montpellier

    Montpellier,
    France

    Site Not Available

  • CHU Nancy

    Nancy,
    France

    Site Not Available

  • CHU Nantes

    Nantes,
    France

    Site Not Available

  • Centre Hospitalier de Nice

    Nice,
    France

    Site Not Available

  • Centre Hospitalier Necker

    Paris,
    France

    Site Not Available

  • Centre Hospitalier Pitié-Salpétrière

    Paris,
    France

    Site Not Available

  • Groupe hospitamier Lariboisière-Fernand Widal-St-Louis

    Paris,
    France

    Site Not Available

  • CHU Poitiers

    Poitiers,
    France

    Site Not Available

  • Centre Hospitalier René Dubos

    Pontoise,
    France

    Site Not Available

  • Centre Hospitalier Annecy-Gennevois

    Pringy,
    France

    Site Not Available

  • CHU Félix Guyon

    Saint-Denis de la Réunion,
    France

    Site Not Available

  • Centre Hospitalier Comminges Pyrénées

    Saint-Gaudens,
    France

    Site Not Available

  • Centre Hospitalier Poulon la Seyne-sur-mer

    Toulon,
    France

    Site Not Available

  • CHU Toulouse

    Toulouse,
    France

    Site Not Available

  • CHRU Tours

    Tours,
    France

    Site Not Available

  • Centre Hospitalier de Valence

    Valence,
    France

    Site Not Available

  • Centre Hospitalier Lucien Hussel

    Vienne,
    France

    Site Not Available

  • CHU Félix Guyon

    Saint-Denis,
    Réunion

    Site Not Available

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