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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:
Sponsor: University of Sao Paulo

Current Primary Outcome: Reduction in the agitation score [ Time Frame: 90 minutes ]

Agitation scores were evaluated through two previously validated specific scales: ACES ( Agitation Calmness Evaluating Scale) and PANSS-EC ( Positive and Negative Symptoms Scale- Excited Component). The measure was collected by a blind rater at baseline and the subsequent measures aimed to evaluate the drug effect over agitation scores.


Original Primary Outcome: Same as current

Current Secondary Outcome: Adverse effects [ Time Frame: 12,24 hours after baseline ]

Aiming to evaluate the occurrence of adverse effects in the 24 hours period of observation after administrating the first injection (Baseline), an exert from the UKU scale (Ugvalg klinisk Undersgelser Side Effect Scale )was applied by a blind rater, to evaluate the presence and intensity of possible side effects.


Original Secondary Outcome: Same as current

Information By: University of Sao Paulo

Dates:
Date Received: November 28, 2011
Date Started: February 2009
Date Completion:
Last Updated: December 1, 2011
Last Verified: February 2009