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Scand J Trauma Resus · May 2020
Randomized Controlled Trial Multicenter StudyNitrous oxide/oxygen plus acetaminophen versus morphine in ST elevation myocardial infarction: open-label, cluster-randomized, non-inferiority study.
- Sandrine Charpentier, Michel Galinski, Vincent Bounes, Agnès Ricard-Hibon, Carlos El-Khoury, Meyer Elbaz, François-Xavier Ageron, Stéphane Manzo-Silberman, Louis Soulat, Frédéric Lapostolle, Alexandre Gérard, Delphine Bregeaud, Vanina Bongard, Eric Bonnefoy-Cudraz, and SCADOL II investigators.
- Emergency Department, Toulouse University Hospital, INSERM UMR 1027, University Toulouse III Paul Sabatier, Toulouse, France. charpentier.s@chu-toulouse.fr.
- Scand J Trauma Resus. 2020 May 12; 28 (1): 36.
BackgroundStudies have shown disparate results on the consequences of morphine use in ST-segment elevation myocardial infarction (STEMI). No study has evaluated alternative treatments that could be at least non-inferior to morphine without its potentially damaging consequences for myocardial function and platelet reactivity. The aim of this study was to evaluate whether nitrous oxide/oxygen plus intravenous acetaminophen (NOO-A) is non-inferior to morphine to control chest pain in STEMI patients.MethodsThis multicenter, open-label, cluster-randomized, controlled, non-inferiority study compared NOO-A with morphine in 684 prehospital patients with ongoing suspected STEMI of < 12 h duration and a pain rating score ≥ 4. The primary endpoint was the proportion of patients achieving pain relief (numeric rating score ≤ 3) after 30 min. Secondary safety endpoints included serious adverse events and death at 30 days.ResultsThe median baseline pain score was 7.0 in both groups. The primary endpoint occurred in 51.7% of the NOO-A group and 73.6% of the morphine group (absolute risk difference - 21.7%; 95% confidence interval - 29.6 to - 13.8). At 30 days, the rate of serious adverse events was 16.0 and 18.8% in the NOO-A and morphine groups respectively (p = NS). The rate of death was 1.8% (NOO-A group) and 3.8% (morphine group) (p = NS).ConclusionAnalgesia provided by NOO-A was inferior to morphine at 30 min in patients with acute STEMI in the prehospital setting. Rates of serious adverse events did not differ between groups.Trial RegistrationClinicalTrials.gov: NCT02198378.
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