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. (SCADOLII)

NCT02198378 Phase 4 COMPLETED

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.

Details

Lead sponsor	University Hospital, Toulouse
Phase	Phase 4
Status	COMPLETED
Enrolment	680
Start date	2014-11
Completion	2017-01

Conditions

• Acute Coronary Syndrome

Interventions

• MEOPA and paracetamol
• Morphine

Primary outcomes

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

Countries

France, Reunion