Haloperidol, lorazepam, or both for psychotic agitation? A multicenter, prospective, double-blind, emergency department study

Am J Emerg Med. 1997 Jul;15(4):335-40. doi: 10.1016/s0735-6757(97)90119-4.


Rapid tranquilization is a routinely practiced method of calming agitated psychotic patients by use of neuroleptics, benzodiazepines, or both in combination. Although several studies have examined the efficacy of the three approaches, none have compared these treatments in a prospective, randomized, double-blind, multicenter trial. Ninety-eight psychotic, agitated, and aggressive patients (73 men and 25 women) were prospectively enrolled during an 18-month period in emergency departments in five university or general hospitals. Patients were randomly assigned to receive intramuscular injections of lorazepam (2 mg), haloperidol (5 mg), or both in combination. Patients in each treatment group received 1 to 6 injections of the same study drug within 12 hours, based on clinical need. They were evaluated hourly after the first injection until at least 12 hours after the last. Efficacy was assessed on the Agitated Behavior Scale (ABS), a modified Brief Psychiatric Rating Scale (MBPRS), Clinical Global impressions (CGI) scale, and an Alertness Scale. Effective symptom reduction was achieved in each treatment group with significant (P < .01) mean decreases from baseline at every hourly ABS evaluation. Significant (P < .05) mean differences on the ABS (hour 1) and MBPRS (hours 2 and 3) suggest that tranquilization was most rapid in patients receiving the combination treatment. Study event incidence (side effects) did not differ significantly between treatment groups, although patients receiving haloperidol alone tended to have more extrapyramidal system symptoms. The superior results produced by the combination treatment support the use of lorazepam plus haloperidol as the treatment of choice for acute psychotic agitation.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Anti-Anxiety Agents / administration & dosage
  • Anti-Anxiety Agents / therapeutic use*
  • Antipsychotic Agents / administration & dosage
  • Antipsychotic Agents / therapeutic use*
  • Brief Psychiatric Rating Scale
  • Demography
  • Double-Blind Method
  • Drug Therapy, Combination
  • Emergency Medical Services
  • Female
  • Haloperidol / administration & dosage
  • Haloperidol / therapeutic use*
  • Humans
  • Lorazepam / administration & dosage
  • Lorazepam / therapeutic use*
  • Male
  • Middle Aged
  • Prospective Studies
  • Psychiatric Status Rating Scales
  • Psychotic Disorders / diagnosis
  • Psychotic Disorders / drug therapy*


  • Anti-Anxiety Agents
  • Antipsychotic Agents
  • Haloperidol
  • Lorazepam