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Randomized Controlled Trial
. 2020 May 12;28(1):36.
doi: 10.1186/s13049-020-00731-y.

Nitrous oxide/oxygen plus acetaminophen versus morphine in ST elevation myocardial infarction: open-label, cluster-randomized, non-inferiority study

Sandrine Charpentier  1   2 , Michel Galinski  3 , Vincent Bounes  4 , Agnès Ricard-Hibon  5 , Carlos El-Khoury  6   7 , Meyer Elbaz  8 , François-Xavier Ageron  9 , Stéphane Manzo-Silberman  10   11 , Louis Soulat  12 , Frédéric Lapostolle  13 , Alexandre Gérard  14 , Delphine Bregeaud  15 , Vanina Bongard  16   17 , Eric Bonnefoy-Cudraz  18   19 ; SCADOL II investigators
Collaborators, Affiliations
Randomized Controlled Trial

Nitrous oxide/oxygen plus acetaminophen versus morphine in ST elevation myocardial infarction: open-label, cluster-randomized, non-inferiority study

Sandrine Charpentier et al. Scand J Trauma Resusc Emerg Med. .

Abstract

Background: Studies 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.

Methods: This 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.

Results: The 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).

Conclusion: Analgesia 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 registration: ClinicalTrials.gov: NCT02198378.

Keywords: Analgesia, prehospital; ST-segment elevation myocardial infarction.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Patient flow chart. Centres 10 and 20 performed the study in the morphine arm and then in the oxide/oxygen plus acetaminophen arm
Fig. 2
Fig. 2
Percent of patients with pain score (numeric rating scale [NRS]) > 3. T, time in minutes
Fig. 3
Fig. 3
Primary endpoint. CI, confidence interval
See this image and copyright information in PMC

References

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