NCT01485692

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: University of Sao Paulo · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Psychomotor Agitation

Interventions

Type	Name	Description
DRUG	haloperidol+promethazine	haloperidol, 2,5mg plus promethazine,25mg, intramuscular injection after baseline measures of agitation, could be repeated twice, if necessary, in the 90 minutes period of observation
DRUG	haloperidol + midazolam	haloperidol, 2,5mg plus midazolam, 7,5 mg, intramuscular injection after baseline measures of agitation, could be repeated twice, if necessary, between the 90 minutes period of observation
DRUG	olanzapine	olanzapine, 10mg, intramuscular injection, after baseline measures of agitation, could be repeated twice, if necessary, between the 90 minutes of observation
DRUG	Ziprasidone	ziprasidone, 10 mg, intramuscular injection after baseline measures of agitation, could be repeated twice, if necessary, between the 90 minutes period of observation

Timeline

• Start date: 2009-02-01
• Primary completion: 2011-03-01
• Completion: 2011-03-01
• First posted: 2011-12-05
• Last updated: 2011-12-05

Locations

1 site across 1 country: Brazil