Comparison of MEOPA + Paracetamol Versus Morphine Treatment in Acute Coronary Syndrome Analgesia.
- Conditions
- Acute Coronary Syndrome
- Interventions
- Registration Number
- NCT02198378
- Lead Sponsor
- University Hospital, Toulouse
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 680
- Patient with STEMI < 12 h treated before hospital admission and pain ≥ 4 on the numerical rating scale.
- 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 hospital team 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MEOPA and paracetamol MEOPA and paracetamol The patient will be equipped with a facemask delivering MEOPA.The gas flow received by the patient is adapted to his/her ventilation. During the same time, an intravenous injection of 1 g paracetamol will be administered. Morphine Morphine Morphine group: administration of morphine will start with a 0.05 mg/kg bolus followed by reinjection of 2 mg every 5 minutes until effective analgesia is obtained, defined as NRS ≤ 3.
- Primary Outcome Measures
Name Time Method Effective analgesia (NRS score≤ 3) at 30 minutes after the start of analgesia 30 minutes after randomisation. The primary outcome measure is effective analgesia, defined by the consensus conference as an NRS score ≤ 3 at 30 minutes after the start of analgesia.
- Secondary Outcome Measures
Name Time Method Adverse event all 5 minutes during 30 minutes Occurrence of an adverse effect, in particular, respiratory depression (RR, respiratory rate \< 10 cycles par minute or respiratory score ≥ R1), nausea, vomiting, sedation (sedation scale (EDS) score ≥2), dizziness, pruritus.
NRS distribution 30 minutes after randomization Distribution of the NRS at 30 minutes and on arrival at the cardiology unit
Effective analgesia all 5 minutes during 30 minutes The time of effective analgesia will be defined for each subject
Trial Locations
- Locations (40)
Centre Hospitalier Louis Pasteur
🇫🇷Chartres, France
Centre Hospitalier Dijon
🇫🇷Dijon, France
Centre Hospitalier Jean Minjoz
🇫🇷Besançon, France
CHU Avicenne
🇫🇷Bobigny, France
Centre Hospitalier Bourg-en-Bresse
🇫🇷Bourg-en-Bresse, France
Centre Hospitalier Alpes Léman
🇫🇷Contamine sur Arve, France
Centre Hospitalier du Val d'Ariège
🇫🇷Foix, France
Centre Hospitalier Raymond Poincaré
🇫🇷Garches, France
Centre Hospitalier Edouard Herriot
🇫🇷Lyon, France
Centre Hospitalier Necker
🇫🇷Paris, France
Centre Hospitalier Comminges Pyrénées
🇫🇷Saint-Gaudens, France
Centre Hospitalier de Valence
🇫🇷Valence, France
Centre Hospitalier Poulon la Seyne-sur-mer
🇫🇷Toulon, France
CHRU Tours
🇫🇷Tours, France
Centre Hospitalier d'Agen
🇫🇷Agen, France
Centre Hospitalier Chateauroux
🇫🇷Chateauroux, France
Hôpital Pellegrin
🇫🇷Bordeaux, France
Centre Hospitalier de Chambéry
🇫🇷Chambéry, France
CHR Bon Secours
🇫🇷Metz, France
CHU d'Estaing
🇫🇷Clermont-Ferrand, France
Centre Hospitalier Sud Francilien
🇫🇷Corbeil-Essonnes, France
Centre Hospitalier Beaujon
🇫🇷Clichy, France
CHU Dupuytren
🇫🇷Limoges, France
Centre Hospitalier Départemental La Roche/Yon
🇫🇷La Roche-sur-Yon, France
Centre Hospitalier de Grenoble
🇫🇷Grenoble, France
CHRU Lille
🇫🇷Lille, France
Centre Hospitalier de la Timone
🇫🇷Marseille, France
Centre Hospitalier Marc Jacquet
🇫🇷Melun, France
CHU Nancy
🇫🇷Nancy, France
Centre Hospitalier Pitié-Salpétrière
🇫🇷Paris, France
CHU Nantes
🇫🇷Nantes, France
Centre Hospitalier de Nice
🇫🇷Nice, France
Centre Hospitalier Annecy-Gennevois
🇫🇷Pringy, France
Centre Hospitalier Lucien Hussel
🇫🇷Vienne, France
CHRU Montpellier
🇫🇷Montpellier, France
Groupe hospitamier Lariboisière-Fernand Widal-St-Louis
🇫🇷Paris, France
Centre Hospitalier René Dubos
🇫🇷Pontoise, France
CHU Félix Guyon
🇷🇪Saint-Denis, Réunion
CHU Toulouse
🇫🇷Toulouse, France
CHU Poitiers
🇫🇷Poitiers, France