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

• Status: Completed
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Sao Paulo
• Treatments: Diphenhydramine; Haloperidol; Haloperidol decanoate; Midazolam; Olanzapine; Promethazine; Ziprasidone

Criteria

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