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Four Interventions in the Management of Psychomotor Agitation, Safety and Efficacy Evaluation

Information source: University of Sao Paulo
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Psychomotor Agitation

Intervention: haloperidol+promethazine (Drug); haloperidol + midazolam (Drug); olanzapine (Drug); Ziprasidone (Drug)

Phase: N/A

Status: Completed

Sponsored by: University of Sao Paulo

Official(s) and/or principal investigator(s):
Celia Mantovani, MD, Principal Investigator, Affiliation: University of Sao Paulo


This study aims to evaluate the efficacy and safety of four options of medications in the management of acute psychomotor agitation,or violence and aggression situations in health services. All of the treatment options are already approved and currently used for this purpose. The options are: haloperidol plus midazolam, haloperidol plus promethazine, olanzapine and ziprasidone. The investigators hypothesized that all treatment options are effective in the treatment of acute agitation, but the combination haloperidol plus promethazine could elicit more adverse affects than the others.

Clinical Details

Official title: Safety and Efficacy of Four Intramuscular Interventions for the Management of Acute Psychomotor Agitation

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Reduction in the agitation score

Secondary outcome: Adverse effects


Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.


Inclusion Criteria:

- patients featuring psychomotor agitation, with clinical need for intramuscular

injection Exclusion Criteria:

- delirium, severe or unstable general medical condition, previous history of severe

adverse effects with one of the treatment options

Locations and Contacts

Hospital das Clinicas da Faculdade de Medicina de Ribeirão Preto, USP, Ribeirão Preto, São Paulo 14048-900, Brazil
Additional Information

Starting date: February 2009
Last updated: December 1, 2011

Page last updated: August 23, 2015

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