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

NCT02198378 | Completed Phase 4

• 2 other identifiers: RC31/13/705013705001
• Study Type: interventional
• Target: 680
• Locations: 2 countries
• Sites: 40

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.

Conditions

Acute Coronary Syndrome

Keywords

premixed nitrous oxide and oxygen; pain; prehospital setting; acute coronary syndrome

Outcome Measures

Primary Outcomes (1)

• Effective analgesia (NRS score≤ 3) at 30 minutes after the start of analgesia

  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.

  30 minutes after randomisation.

Secondary Outcomes (3)

• Adverse event

  all 5 minutes during 30 minutes

• NRS distribution

  30 minutes after randomization

• Effective analgesia

  all 5 minutes during 30 minutes

Study Arms (2)

Morphine

ACTIVE COMPARATOR

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.

Drug: Morphine

MEOPA and paracetamol

EXPERIMENTAL

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.

Drug: MEOPA and paracetamol

Interventions

MEOPA and paracetamol 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.

Also known as: Entonox 170 bar

MEOPA and paracetamol

Morphine 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.

Also known as: Morphine Renaudin 1mg/ml

Morphine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (40)

Centre Hospitalier d'Agen

Agen, France

Location

Centre Hospitalier Jean Minjoz

Besançon, France

Location

CHU Avicenne

Bobigny, France

Location

Hôpital Pellegrin

Bordeaux, France

Location

Centre Hospitalier Bourg-en-Bresse

Bourg-en-Bresse, France

Location

Centre Hospitalier de Chambéry

Chambéry, France

Location

Centre Hospitalier Louis Pasteur

Chartres, France

Location

Centre Hospitalier Chateauroux

Châteauroux, France

Location

CHU d'Estaing

Clermont-Ferrand, France

Location

Centre Hospitalier Beaujon

Clichy, France

Location

Centre Hospitalier Alpes Léman

Contamine-sur-Arve, France

Location

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, France

Location

Centre Hospitalier Dijon

Dijon, France

Location

Centre Hospitalier du Val d'Ariège

Foix, France

Location

Centre Hospitalier Raymond Poincaré

Garches, France

Location

Centre Hospitalier de Grenoble

Grenoble, France

Location

Centre Hospitalier Départemental La Roche/Yon

La Roche-sur-Yon, France

Location

CHRU Lille

Lille, France

Location

CHU Dupuytren

Limoges, France

Location

Centre Hospitalier Edouard Herriot

Lyon, France

Location

Centre Hospitalier de la Timone

Marseille, France

Location

Centre Hospitalier Marc Jacquet

Melun, France

Location

CHR Bon Secours

Metz, France

Location

CHRU Montpellier

Montpellier, France

Location

CHU Nancy

Nancy, France

Location

CHU Nantes

Nantes, France

Location

Centre Hospitalier de Nice

Nice, France

Location

Centre Hospitalier Necker

Paris, France

Location

Centre Hospitalier Pitié-Salpétrière

Paris, France

Location

Groupe hospitamier Lariboisière-Fernand Widal-St-Louis

Paris, France

Location

CHU Poitiers

Poitiers, France

Location

Centre Hospitalier René Dubos

Pontoise, France

Location

Centre Hospitalier Annecy-Gennevois

Pringy, France

Location

Centre Hospitalier Comminges Pyrénées

Saint-Gaudens, France

Location

Centre Hospitalier Poulon la Seyne-sur-mer

Toulon, France

Location

CHU Toulouse

Toulouse, France

Location

CHRU Tours

Tours, France

Location

Centre Hospitalier de Valence

Valence, France

Location

Centre Hospitalier Lucien Hussel

Vienne, France

Location

CHU Félix Guyon

Saint-Denis, Reunion

Location

Related Publications (6)

• 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.

  PMID: 21237321 BACKGROUND

• 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.

  PMID: 10973764 BACKGROUND

• 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.

  PMID: 17569677 BACKGROUND

• 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.

  PMID: 19004841 BACKGROUND

• 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.

  PMID: 18191746 BACKGROUND

• 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.

  PMID: 32398160 DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome; Pain

Interventions

Meopa; Acetaminophen; Morphine

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Sandrine Charpentier, PH,MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2014
• First Posted: July 23, 2014
• Study Start: November 1, 2014
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: February 5, 2018

Record last verified: 2018-02

Locations

FR (39); RE (1)