J. Battaglia et al., HALOPERIDOL, LORAZEPAM, OR BOTH FOR PSYCHOTIC AGITATION - A MULTICENTER, PROSPECTIVE, DOUBLE-BLIND, EMERGENCY DEPARTMENT STUDY, The American journal of emergency medicine, 15(4), 1997, pp. 335-340
Rapid tranquilization is a routinely practiced method of calming agita
ted psychotic patients by use of neuroleptics, benzodiazepines, or bot
h in combination, Although several studies have examined the efficacy
of the three approaches, none have compared these treatments in a pros
pective, randomized, double-blind, multicenter trial. Ninety eight psy
chotic, agitated, and aggressive patients (73 men and 25 women) were p
rospectively enrolled during an 18-month period in emergency departmen
ts in five university or general hospitals. Patients were randomly ass
igned to receive intramuscular injections of lorazepam (2 mg), haloper
idol (5 mg), or both in combination, Patients in each treatment group
received 1 to 6 injections of the same study drug within 12 hours, bas
ed on clinical need, They were evaluated hourly after the first inject
ion until at least 12 hours after the last. Efficacy was assessed on t
he Agitated Behavior Scale (ABS), a modified Brief Psychiatric Rating
Scale (MBPRS), Clinical Global Impressions (CGI) scale, and an Alertne
ss Scale. Effective symptom reduction was achieved in each treatment g
roup with significant (P < .01) mean decreases from baseline at every
hourly ABS evaluation. Significant (P < .05) mean differences on the A
BS (hour 1) and MBPRS (hours 2 and 3) suggest that tranquilization was
most rapid in patients receiving the combination treatment, Study eve
nt incidence (side effects) did not differ significantly between treat
ment groups, although patients receiving haloperidol alone tended to h
ave more extrapyramidal system symptoms, The superior results produced
by the combination treatment support the use of lorazepam plus halope
ridol as the treatment of choice for acute psychotic agitation. (C) 19
97 by W.B. Saunders Company.