A clinical study with prospective design on the efficacy of Haloperidol 5 mg i.m. and Diazepam 10 mg i.v., compared with Chlorpromazine 100 mg i.m., in the treatment of agitated state, was conducted on 77 patients in a 3 months period. The purpose was to find the most rapid, dependable and safest treatment for agitated state.

Methods: Agitated state, was defined in the inclusion CRITERIA as a generalized with or without aggressivity, that can not be controlled persuasively, without neurological deficits. Admitted patients, fitting description of inclusion CRITERIA, and screened by EXCLUSION CRITERIA (age <18 or> 45 year, respiratory distress, chest pain, drug using, alcohol drinking, febrile, hypotension, cardiopulmonary disorder, head trauma, neurological deficits), were included in this study, 39 patients were treated with Diazepam 10 mg i.v. and Haloperidol 5 mg i.m. (Group I), and 38 patients with Chlorpromazine 100 mg i.m. (Group II). Efficacy profiles, which were clinically assessed and statistically compared, are: rapidity of the result; rapidity of the onset of sleep; duration of sleep; dependability (% cases of successful result without recurred agitation); clinical safety (% cases without side effects); potential safety (% cases with the drops in blood pressure never exceeded 10 % of initial blood pressure, with the smallest mean drops in blood pressure, in 4 consecutive examinations).

Results: Mean rapidity of the result and onset of sleep for Group I (7,64 : 8,72 minute) were significantly faster than Group II (28,11 : 29,76 minute). Duration of sleep for Group I (99,74 minute) is not significantly different from Group II (96,58 minute). Dependability of Group I (89,79%) was significantly higher than Group II (71,05%). Potential safety of Group I in 15; 30; 60; 180 minute examinations (74,36%, ^5,51 /2,56 mmHg; 64,10%, ^92,3/3,84 mmHg; 64,10%, ^7,82 / 2,95 mmHg; 69,23%, ^5,64/1,67 mmHg) were significantly higher than Group II (42,105%, ^10,79/6,58 mmHg; 39,47%, ^14,34/8,55 mmHg; 47,37%, ^12,63/6,97 mmHg; 60,53%, ^8,29/4,74 mmHg).

Conclusion: Efficacy of Haloperidol and Diazepam were clinically better than Chlorpromazine for the treatment of agitated state.

Key words: efficacy, rapidity, dependability, safety.