drugset / Trial / NCT01485692

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

NCT01485692

Completed 120 enrolled University of Sao Paulo
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2009-02
Primary completion
2011-03
Completion
2011-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator Haloperidol Other / unclassified 2.5 mg Intramuscular
Comparator Midazolam Small molecule 7.5 mg Intramuscular
Comparator Olanzapine Small molecule 10 mg Intramuscular
Comparator Promethazine Small molecule 25 mg Intramuscular
Comparator Ziprasidone Small molecule 10 mg Intramuscular

Indications

No indication recorded.