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

NCT ID: NCT02198378

Last Updated: 2018-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 680 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2017-01-31

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.

Conditions

Acute Coronary Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Morphine

Intervention Type: DRUG

Bolus of 2 mg intravenously if EN = 4 or 5 and 3 mg bolus if EN\> 6 followed by reinjection of 2mg every 5 minutes until effective analgesia.

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.

Group Type: EXPERIMENTAL

MEOPA and paracetamol

Intervention Type: DRUG

The patient will be equipped with a facemask after he/she has been informed. The facemask is adapted to the patient. The patient breathes normally in the mask which is held in place by a member of the SMUR team who has received previous training in use of MEOPA. The gas flow received by the patient is adapted to his/her ventilation.

Interventions

MEOPA and paracetamol

The patient will be equipped with a facemask after he/she has been informed. The facemask is adapted to the patient. The patient breathes normally in the mask which is held in place by a member of the SMUR team who has received previous training in use of MEOPA. The gas flow received by the patient is adapted to his/her ventilation.

Intervention Type: DRUG

Morphine

Bolus of 2 mg intravenously if EN = 4 or 5 and 3 mg bolus if EN\> 6 followed by reinjection of 2mg every 5 minutes until effective analgesia.

Intervention Type: DRUG

Other Intervention Names

Entonox 170 bar; Morphine Renaudin 1mg/ml

Eligibility Criteria

Inclusion Criteria

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

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 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sandrine Charpentier, PH,MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

Centre Hospitalier d'Agen

Agen, , France

Centre Hospitalier Jean Minjoz

Besançon, , France

CHU Avicenne

Bobigny, , France

Hôpital Pellegrin

Bordeaux, , France

Centre Hospitalier Bourg-en-Bresse

Bourg-en-Bresse, , France

Centre Hospitalier de Chambéry

Chambéry, , France

Centre Hospitalier Louis Pasteur

Chartres, , France

Centre Hospitalier Chateauroux

Châteauroux, , France

CHU d'Estaing

Clermont-Ferrand, , France

Centre Hospitalier Beaujon

Clichy, , France

Centre Hospitalier Alpes Léman

Contamine-sur-Arve, , France

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, , France

Centre Hospitalier Dijon

Dijon, , France

Centre Hospitalier du Val d'Ariège

Foix, , France

Centre Hospitalier Raymond Poincaré

Garches, , France

Centre Hospitalier de Grenoble

Grenoble, , France

Centre Hospitalier Départemental La Roche/Yon

La Roche-sur-Yon, , France

CHRU Lille

Lille, , France

CHU Dupuytren

Limoges, , France

Centre Hospitalier Edouard Herriot

Lyon, , France

Centre Hospitalier de la Timone

Marseille, , France

Centre Hospitalier Marc Jacquet

Melun, , France

CHR Bon Secours

Metz, , France

CHRU Montpellier

Montpellier, , France

CHU Nancy

Nancy, , France

CHU Nantes

Nantes, , France

Centre Hospitalier de Nice

Nice, , France

Centre Hospitalier Necker

Paris, , France

Centre Hospitalier Pitié-Salpétrière

Paris, , France

Groupe hospitamier Lariboisière-Fernand Widal-St-Louis

Paris, , France

CHU Poitiers

Poitiers, , France

Centre Hospitalier René Dubos

Pontoise, , France

Centre Hospitalier Annecy-Gennevois

Pringy, , France

Centre Hospitalier Comminges Pyrénées

Saint-Gaudens, , France

Centre Hospitalier Poulon la Seyne-sur-mer

Toulon, , France

CHU Toulouse

Toulouse, , France

CHRU Tours

Tours, , France

Centre Hospitalier de Valence

Valence, , France

Centre Hospitalier Lucien Hussel

Vienne, , France

CHU Félix Guyon

Saint-Denis, , Reunion

Countries

France; Reunion

References

Danchin N, Puymirat E, Aissaoui N, Adavane S, Durand E. [Epidemiology of acute coronary syndromes in France and in Europe]. Ann Cardiol Angeiol (Paris). 2010 Dec;59 Suppl 2:S37-41. doi: 10.1016/S0003-3928(10)70008-1. French.

Reference Type: BACKGROUND

PMID: 21237321 (View on PubMed)

Myocardial infarction redefined--a consensus document of The Joint European Society of Cardiology/American College of Cardiology Committee for the redefinition of myocardial infarction. Eur Heart J. 2000 Sep;21(18):1502-13. doi: 10.1053/euhj.2000.2305.

Reference Type: BACKGROUND

PMID: 10973764 (View on PubMed)

Task Force for Diagnosis and Treatment of Non-ST-Segment Elevation Acute Coronary Syndromes of European Society of Cardiology; Bassand JP, Hamm CW, Ardissino D, Boersma E, Budaj A, Fernandez-Aviles F, Fox KA, Hasdai D, Ohman EM, Wallentin L, Wijns W. Guidelines for the diagnosis and treatment of non-ST-segment elevation acute coronary syndromes. Eur Heart J. 2007 Jul;28(13):1598-660. doi: 10.1093/eurheartj/ehm161. Epub 2007 Jun 14. No abstract available.

Reference Type: BACKGROUND

PMID: 17569677 (View on PubMed)

Van de Werf F, Bax J, Betriu A, Blomstrom-Lundqvist C, Crea F, Falk V, Filippatos G, Fox K, Huber K, Kastrati A, Rosengren A, Steg PG, Tubaro M, Verheugt F, Weidinger F, Weis M; ESC Committee for Practice Guidelines (CPG). Management of acute myocardial infarction in patients presenting with persistent ST-segment elevation: the Task Force on the Management of ST-Segment Elevation Acute Myocardial Infarction of the European Society of Cardiology. Eur Heart J. 2008 Dec;29(23):2909-45. doi: 10.1093/eurheartj/ehn416. Epub 2008 Nov 12. No abstract available.

Reference Type: BACKGROUND

PMID: 19004841 (View on PubMed)

Canadian Cardiovascular Society; American Academy of Family Physicians; American College of Cardiology; American Heart Association; Antman EM, Hand M, Armstrong PW, Bates ER, Green LA, Halasyamani LK, Hochman JS, Krumholz HM, Lamas GA, Mullany CJ, Pearle DL, Sloan MA, Smith SC Jr, Anbe DT, Kushner FG, Ornato JP, Pearle DL, Sloan MA, Jacobs AK, Adams CD, Anderson JL, Buller CE, Creager MA, Ettinger SM, Halperin JL, Hunt SA, Lytle BW, Nishimura R, Page RL, Riegel B, Tarkington LG, Yancy CW. 2007 focused update of the ACC/AHA 2004 guidelines for the management of patients with ST-elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2008 Jan 15;51(2):210-47. doi: 10.1016/j.jacc.2007.10.001. No abstract available.

Reference Type: BACKGROUND

PMID: 18191746 (View on PubMed)

Charpentier S, Galinski M, Bounes V, Ricard-Hibon A, El-Khoury C, Elbaz M, Ageron FX, Manzo-Silberman S, Soulat L, Lapostolle F, Gerard A, Bregeaud D, Bongard V, Bonnefoy-Cudraz E; SCADOL II investigators. Nitrous oxide/oxygen plus acetaminophen versus morphine in ST elevation myocardial infarction: open-label, cluster-randomized, non-inferiority study. Scand J Trauma Resusc Emerg Med. 2020 May 12;28(1):36. doi: 10.1186/s13049-020-00731-y.

Reference Type: DERIVED

PMID: 32398160 (View on PubMed)

Other Identifiers

13705001

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

RC31/13/7050

Identifier Type: -

Identifier Source: org_study_id