CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 680 enrolled
Drug / intervention
MEOPA and paracetamol +1 moredrug
Likely dose
Morphine 2 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02198378
NCT02198378Phase 4Completed

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.

University Hospital, Toulouse·interventional·Posted Jul 23, 2014·Updated Feb 5, 2018

In Brief

A Phase 4 clinical trial evaluating MEOPA and paracetamol and Morphine for Acute Coronary Syndrome. Completed, enrolled 680 participants across 40 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance, Reunion
Collaborators--

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJul 23, 2014
Enrollment StartNov 1, 2014
Primary CompletionJan 1, 2017
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 11.9 years ago

Interventions

MEOPA and paracetamoldrug

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.

Morphinedrug

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.