Midazolam versus morphine in acute cardiogenic pulmonary oedema: results of a multicentre, open-label, randomized controlled trial
Por:
Dominguez-Rodriguez, A, Suero-Mendez, C, Burillo-Putze, G, Gil, V, Calvo-Rodriguez, R, Pinera-Salmeron, P, Llorens, P, Martin-Sanchez, F, Abreu-Gonzalez, P and Miro, O
Publicada:
1 oct 2022
Ahead of Print:
1 jul 2022
Resumen:
Aims Benzodiazepines have been used as safe anxiolytic drugs for decades and some authors have suggested they could be an alternative for morphine for treating acute cardiogenic pulmonary oedema (ACPE). We compared the efficacy and safety of midazolam and morphine in patients with ACPE. Methods and results A randomized, multicentre, open-label, blinded endpoint clinical trial was performed in seven Spanish emergency departments (EDs). Patients >18 years old clinically diagnosed with ACPE and with dyspnoea and anxiety were randomized (1:1) at ED arrival to receive either intravenous midazolam or morphine. Efficacy was assessed by in-hospital all-cause mortality (primary endpoint). Safety was assessed through serious adverse event (SAE) reporting, and the composite endpoint included 30-day mortality and SAE. Analyses were made on an intention-to-treat basis. The trial was stopped early after a planned interim analysis by the safety monitoring committee. At that time, 111 patients had been randomized: 55 to midazolam and 56 to morphine. There were no significant differences in the primary endpoint (in-hospital mortality for midazolam vs. morphine 12.7% vs. 17.9%; risk ratio[RR] 0.71, 95% confidence interval [CI] 0.29-1.74; p = 0.60). SAE were less common with midazolam versus morphine (18.2% vs. 42.9%; RR 0.42, 95% CI 0.22-0.80; p = 0.007), as were the composite endpoint (23.6% vs. 44.6%; RR 0.53, 95% CI 0.30-0.92; p = 0.03). Conclusion Although the number of patients was too small to draw final conclusions and there were no significant differences in mortality between midazolam and morphine, a significantly higher rate of SAEs was found in the morphine group.
Filiaciones:
Dominguez-Rodriguez, A:
Univ Europea Canarias, Dept Cardiol, Hosp Univ Canarias, Tenerife, Spain
CIBER Enfermedades Cardiovasc CIBERCV, Madrid, Spain
Suero-Mendez, C:
Hosp Axarquia, Malaga, Spain
Burillo-Putze, G:
Univ La Laguna, Emergency Dept, Hosp Univ Canarias, Tenerife, Spain
Gil, V:
Univ Barcelona, Hosp Clin, Emergency Dept, Inst Invest Biomed August Pi i Sunyer IDIBAPS, Barcelona, Spain
Calvo-Rodriguez, R:
Hosp Univ Reina Sofia, Emergency Dept, Cordoba, Spain
Pinera-Salmeron, P:
Hosp Gen Univ Reina Sofia, Emergency Dept, Murcia, Spain
:
Hosp Gen Alicante, Short Stay Unit, Emergency Dept, Alicante, Spain
Hosp Gen Alicante, Home Hospitalizat, Alicante, Spain
Martin-Sanchez, F:
Univ Complutense, Hosp Clin San Carlos, Emergency Dept, Madrid, Spain
Abreu-Gonzalez, P:
Univ La Laguna, Fac Med, Dept Physiol, Tenerife, Spain
Miro, O:
Univ Barcelona, Hosp Clin, Emergency Dept, Inst Invest Biomed August Pi i Sunyer IDIBAPS, Barcelona, Spain
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