title: Are low doses of antipsychotics effective in the management of psychomotor agitation? A randomized, rated-blind trial of 4 intramuscular interventions.
abstract: BACKGROUND
  Psychomotor agitation can be associated with a wide range of medical conditions. Although clinical practice advocates the use of several drugs for the management of psychomotor agitation, there are still very few controlled studies comparing the profiles of action and the adverse effects of different drugs that induce tranquilization.
  
  
  OBJECTIVE
  The purpose of this study was to compare the efficacy and safety of 4 low-dose pharmacological interventions used to control psychomotor agitation guided by the clinical response.
  
  
  METHODS
  Using a randomized, rated-blind design, 100 agitated patients were assigned to receive 1 of 4 treatments: haloperidol (2.5 mg) + promethazine (25 mg) (HLP + PMZ), haloperidol (2.5 mg) + midazolam (7.5 mg) (HLP + MID), ziprasidone (10 mg) (ZIP), or olanzapine (10 mg) (OLP). Patients were evaluated just before the intervention and after 30, 60, and 90 minutes, using the Agitation-Calmness Evaluating Scale. Adverse effects were assessed within 24 hours after the intervention, using selected items from the UKU Scale (Ugvalg Klinisk Undersgelser Side Effect Scale). According to the clinical indication, medication could be repeated twice after the first injection. Data were analyzed using general linear model with repeated measures and logistic regression.
  
  
  RESULTS
  All treatment options promoted a reduction in agitation, without causing excessive sedation, although a lower reduction in agitation was observed with HLP + PMZ and ZIP compared with HLP + MID and OLZ. The need for an additional dose of medication was observed in 22 patients, and only 8 remained agitated during the entire 90-minute period. A higher risk for the development of extrapyramidal symptoms within the following 24 hours was observed with HLP + PMZ.
  
  
  CONCLUSIONS
  Low doses of haloperidol combined with midazolam can be as effective as olanzapine in reducing psychomotor agitation without increasing the risk of extrapyramidal effects. Because of the higher risk for the occurrence of extrapyramidal symptoms, the combination of haloperidol with promethazine should be considered a second-line treatment option.
authors.affiliation: Division of Psychiatry, Department of Neurosciences and Behavior, Faculty of Medicine of Ribeirão Preto School of Medicine, University of São Paulo, São Paulo, Brazil.
authors.forename: Celia
authors.initials: C
authors.lastname: Mantovani
authors.forename: Cybelli Morello
authors.initials: CM
authors.lastname: Labate
authors.forename: Alcion
authors.initials: A
authors.lastname: Sponholz
authors.forename: João Mazzoncini
authors.initials: JM
authors.lastname: de Azevedo Marques
authors.forename: Vinicius Guandalini
authors.initials: VG
authors.lastname: Guapo
authors.forename: Maria Eugênia
authors.initials: ME
authors.lastname: de Simone Brito dos Santos
authors.forename: Antonio
authors.initials: A
authors.lastname: Pazin-Filho
authors.forename: Cristina Marta
authors.initials: CM
authors.lastname: Del-Ben
mesh_terms: D000328:Adult; D014150:Antipsychotic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001480:Basal Ganglia Diseases / Q000139:chemically induced* / Q000453:epidemiology; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D016014:Linear Models; D016015:Logistic Models; D008297:Male; D011595:Psychomotor Agitation / Q000188:drug therapy*; D016037:Single-Blind Method; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D014150:Antipsychotic Agents