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

Acute Coronary Syndrome Clinical Trial

— SCADOLII  

Official title:

Analgesia of Acute Coronary Syndromes With ST-segment Elevation in a Pre-hospital Setting. Randomized Non-inferiority Trial of the Association MEOPA + Paracetamol Versus Morphine.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02198378
• Other study ID #: RC31/13/7050
• Secondary ID: 13705001
• Status: Completed
• Phase: Phase 4
• First received: July 22, 2014
• Last updated: February 2, 2018
• Start date: November 2014
• Est. completion date: January 2017

Study information

• Verified date: February 2018
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 680
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
France	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	Chateauroux
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
Réunion	CHU Félix Guyon	Saint-Denis

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Countries where clinical trial is conducted

France,  Réunion, 

References & Publications (5)

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. Review. Erratum in: J Am Coll Cardiol. 2008 Mar 4;51(9):977. — View Citation

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. — View Citation

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. Review. — View Citation

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, Fernández-Avilés 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. Epub 2007 Jun 14. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Adverse event	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.	all 5 minutes during 30 minutes
Secondary	NRS distribution	Distribution of the NRS at 30 minutes and on arrival at the cardiology unit	30 minutes after randomization
Secondary	Effective analgesia	The time of effective analgesia will be defined for each subject	all 5 minutes during 30 minutes