Abstract:
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,...