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.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 680
- 试验地点
- 40
- 主要终点
- Effective analgesia (NRS score≤ 3) at 30 minutes after the start of analgesia
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with STEMI < 12 h treated before hospital admission and pain ≥ 4 on the numerical rating scale.
排除标准
- •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
研究组 & 干预措施
Morphine
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.
干预措施: Morphine (Drug)
MEOPA and paracetamol
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.
干预措施: MEOPA and paracetamol (Drug)
结局指标
主要结局
Effective analgesia (NRS score≤ 3) at 30 minutes after the start of analgesia
时间窗: 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.
次要结局
- Adverse event(all 5 minutes during 30 minutes)
- NRS distribution(30 minutes after randomization)
- Effective analgesia(all 5 minutes during 30 minutes)