Rapid tranquillisation for agitated patients in emergency psychiatric rooms: A randomised trial of midazolam versus haloperidol plus promethazine.

Compared 2 widely used drug treatments for people with aggression or agitation due to mental illness. A pragmatic, randomised clinical trial was used to examine 301 aggressive or agitated people in 3 psychiatric emergency rooms in Rio de Janeiro, Brazil. 151 patients were randomised to midazolam, and 150 to haloperidol-promethazine mix. Follow up for the primary outcome was available for 298 (99%): 134/151 (89%) of patients given midazolam were tranquil or asleep after 20 minutes compared with 101/150 (67%) of those given haloperidol plus promethazine {relative risk 1.32 (95% confidence interval 1.16 to 1.49)}. By 40 minutes, midazolam still had a statistically and clinically significant 13% relative advantage {1.13 (1.01 to 1.26)}. After 1 hour, about 90% of both groups were tranquil or asleep. One important adverse event occurred in each group: a patient given midazolam had transient respiratory depression, and one given haloperidol-promethazine had a grande mal seizure. Both treatments were effective. Midazolam was more rapidly sedating than haloperidol-promethazine, reducing the time people are exposed to aggression. Adverse effects and resources to deal with them should be considered in the choice of the treatment. (PsycInfo Database Record (c) 2021 APA, all rights reserved)