title: Efficacy and safety of valproic acid versus haloperidol in patients with acute agitation: results of a randomized, double-blind, parallel-group trial.
abstract: The objective of this study was to compare the efficacy of valproate versus haloperidol in decreasing the agitation level in affected patients in the emergency department. We assigned 80 acutely agitated patients to receive either intravenous sodium valproate (20 mg/kg) or intramuscular haloperidol (5 mg/1 ml). Agitation was measured at baseline and 30 min after the first injection using the Agitation-Calmness Evaluation Scale (ACES), the Positive and Negative Syndrome Scale-Excited Component subscale, and the Agitated Behavior Scale. For 80 patients treated with sodium valproate, the mean ± SD dosage was 1541.5 ± 286 mg (range 940-2400). The mean postintervention ACES scores from baseline to 30 min after drug injection were 4.73 (SD = 1.93) for the valproate group and 5.45 (SD = 2.09) for the haloperidol group (P = 0.028). No significant differences were observed in terms of the mean changes 30 min after the intervention for two additional agitation scales. A larger proportion of patients in the haloperidol group experienced intense sedation (36.2%, P < 0.001) and extrapyramidal symptoms (8.7%, P = 0.007) compared with the valproate group (2.5% for intense sedation, no patient for extrapyramidal symptoms). The findings suggest that in the clinical practice setting of emergency psychiatry, intravenous valproate is as effective as haloperidol in reducing agitation, with a better safety profile.
authors.affiliation: aSchool of Medicine bDepartment of Emergency Medicine, Imam Hossein Hospital cSafety Promotion and Injury Prevention Research Center dProteomics Research Center, Faculty of Paramedical Sciences, Shahid Beheshti University of Medical Sciences, Tehran 17666-33815, Iran.
authors.forename: Shadi
authors.initials: S
authors.lastname: Asadollahi
authors.forename: Kamran
authors.initials: K
authors.lastname: Heidari
authors.forename: Hamidreza
authors.initials: H
authors.lastname: Hatamabadi
authors.forename: Reza
authors.initials: R
authors.lastname: Vafaee
authors.forename: Somayeh
authors.initials: S
authors.lastname: Yunesian
authors.forename: Alireza
authors.initials: A
authors.lastname: Azadbakht
authors.forename: Ladan
authors.initials: L
authors.lastname: Mirmohseni
mesh_terms: D000328:Adult; D018692:Antimanic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D014150:Antipsychotic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001480:Basal Ganglia Diseases / Q000139:chemically induced / Q000175:diagnosis; D004311:Double-Blind Method; D005260:Female; D006220:Haloperidol / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011595:Psychomotor Agitation / Q000175:diagnosis* / Q000188:drug therapy* / Q000523:psychology; D014635:Valproic Acid / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D018692:Antimanic Agents; D014150:Antipsychotic Agents; D014635:Valproic Acid; D006220:Haloperidol