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
