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Completed

NCT Number: NCT02198378

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Centre Hospitalier d'Agen, Agen, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Entonox 170 bar

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.

Other names: Morphine Renaudin 1mg/ml

Primary outcomes

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

    Time frame: 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 outcomes

  1. Adverse event

    Time frame: 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.

  2. NRS distribution

    Time frame: 30 minutes after randomization

    Distribution of the NRS at 30 minutes and on arrival at the cardiology unit

  3. Effective analgesia

    Time frame: all 5 minutes during 30 minutes

    The time of effective analgesia will be defined for each subject

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study 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.

Acronym: SCADOLII

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jul 23, 2014
Registry last updated
Feb 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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