OBJECTIVE: To compare two widely used drug treatments for people with aggression or agitation due to mental illness. DESIGN: Pragmatic, randomised clinical trial. SETTING: Three psychiatric emergency rooms in Rio de Janeiro, Brazil. SUBJECTS:301 aggressive or agitated people. INTERVENTIONS: Open treatment with intramuscular midazolam or intramuscular haloperidol plus promethazine. MAIN OUTCOME MEASURES: Patients tranquil or sedated at 20 minutes. SECONDARY OUTCOMES: patients tranquil or asleep by 40, 60, and 120 minutes; restrained or given extra drugs within 2 hours; severe adverse events; another episode of agitation or aggression; needing extra visits from doctor during first 24 hours; overall antipsychotic load in first 24 hours; and not discharged by two weeks. RESULTS: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. CONCLUSIONS: 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.
RCT Entities:
OBJECTIVE: To compare two widely used drug treatments for people with aggression or agitation due to mental illness. DESIGN: Pragmatic, randomised clinical trial. SETTING: Three psychiatric emergency rooms in Rio de Janeiro, Brazil. SUBJECTS: 301 aggressive or agitated people. INTERVENTIONS: Open treatment with intramuscular midazolam or intramuscular haloperidol plus promethazine. MAIN OUTCOME MEASURES: Patients tranquil or sedated at 20 minutes. SECONDARY OUTCOMES: patients tranquil or asleep by 40, 60, and 120 minutes; restrained or given extra drugs within 2 hours; severe adverse events; another episode of agitation or aggression; needing extra visits from doctor during first 24 hours; overall antipsychotic load in first 24 hours; and not discharged by two weeks. RESULTS: 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. CONCLUSIONS: 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.
Authors: F Moritz; F Bauer; A Boyer; P Lemarchand; J M Kerleau; E Moirot; C Navarre; J M Muller Journal: Presse Med Date: 1999-10-09 Impact factor: 1.228
Authors: J N Nestoros; B E Suranyi-Cadotte; R C Spees; G Schwartz; N P Nair Journal: Prog Neuropsychopharmacol Biol Psychiatry Date: 1982 Impact factor: 5.067
Authors: Gisele Huf; Evandro da Silva Freire Coutinho; Hugo M Fagundes; Edmar S Oliveira; Jose Ramon R A Lopez; Marcio Gewandszajder; Andreia da Luz Carvalho; Alexandre Keusen; Clive E Adams Journal: BMC Psychiatry Date: 2002-01-22 Impact factor: 3.630
Authors: Clayton Gonçalves de Almeida; Mariana Del Grossi Moura; Silvio Barberato-Filho; Fernando de Sá Del Fiol; Rogério Heládio Lopes Motta; Cristiane de Cássia Bergamaschi Journal: Psychiatr Q Date: 2017-12