A DOUBLE-BLIND-STUDY OF LORAZEPAM VERSUS THE COMBINATION OF HALOPERIDOL AND LORAZEPAM IN MANAGING AGITATION

Study Objective. To compare the utility of intramuscular lorazepam (LZ ) with the combination of intramuscular haloperidol (HDL) and LZ to co ntrol acutely agitated behavior. Design. Randomized double-blind compa rison. Setting. Psychiatric emergency service of a large, university-a ffiliated, municipal hospital. Patients. Twenty subjects treated on th e psychiatric emergency service. Interventions. Patients received an i njection of either LZ 2 mg (11 patients) or HDL 5 mg plus LZ 2 mg (9 p atients). The Overt Aggression Scale (GAS), visual analog scales refle cting agitation and hostility, and the Clinical Global Impressions (CG I) severity scale were administered at baseline and 30, 60, 120, and 1 80 minutes after the injection. Measurements and Main Results. Planned data comparisons included categoric assignment of patients as improve d, as defined by decreases in outcome measures 60 minutes after the in jection, as well as continuous variables up to 180 minutes after the i njection. A significantly greater percentage of subjects receiving com bined treatment improved on the specific measures 60 minutes after dos ing (p<0.05). Kaplan-Meier survival analyses showed significant betwee n-group differences in survival curves plotted for the entire study pe riod (p<0.05). Repeated measures analyses of variance studying group d ifferences showed that both groups improved over time, but between-gro up differences were not significant. The powers of these analyses were low due to the small sample. No serious adverse effects occurred in e ither treatment group. Conclusion. Our results suggest superior effica cy for HDL-LZ over LZ alone. Categoric tests of improvement at 60 minu tes provided the strongest evidence of group differences.