drugset / Trial / NCT01485692
Four Interventions in the Management of Psychomotor Agitation, Safety and Efficacy Evaluation
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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.