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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
120
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
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
olanzapine, 10mg, intramuscular injection, after baseline measures of agitation, could be repeated twice, if necessary, between the 90 minutes of observation
ziprasidone, 10 mg, intramuscular injection after baseline measures of agitation, could be repeated twice, if necessary, between the 90 minutes period of observation
Hospital das Clinicas da Faculdade de Medicina de Ribeirão Preto, USP
Ribeirão Preto, São Paulo, Brazil
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.
Time frame: 90 minutes
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.
Time frame: 12,24 hours after baseline
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