Psychomotor Agitation Clinical Trial
Official title:
Safety and Efficacy of Four Intramuscular Interventions for the Management of Acute Psychomotor Agitation
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.
Status | Completed |
Enrollment | 120 |
Est. completion date | March 2011 |
Est. primary completion date | March 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 55 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital das Clinicas da Faculdade de Medicina de Ribeirão Preto, USP | Ribeirão Preto | São Paulo |
Lead Sponsor | Collaborator |
---|---|
University of Sao Paulo |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reduction in the agitation score | Agitation scores were evaluated through two previously validated specific scales: ACES ( Agitation Calmness Evaluating Scale) and PANSS-EC ( Positive and Negative Symptoms Scale- Excited Component). The measure was collected by a blind rater at baseline and the subsequent measures aimed to evaluate the drug effect over agitation scores. | 90 minutes | No |
Secondary | Adverse effects | Aiming to evaluate the occurrence of adverse effects in the 24 hours period of observation after administrating the first injection (Baseline), an exert from the UKU scale (Ugvalg klinisk Undersgelser Side Effect Scale )was applied by a blind rater, to evaluate the presence and intensity of possible side effects. | 12,24 hours after baseline | Yes |
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