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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Adverse effects [ Time Frame: 12,24 hours after baseline ]
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