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

University of Sao Paulo

Status: Completed

Conditions: Psychomotor Agitation

Treatments: Drug: Ziprasidone; Drug: haloperidol + midazolam; Drug: haloperidol+promethazine; Drug: olanzapine

Study type: Interventional

Funder types: Other

Identifiers

NCT01485692

UE0001

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 4 patient groups

ziprasidone injection

Active Comparator group

Description:

ziprasidone injection after baseline measures of agitation, could be repeated twice, if necessary, between the 90 minutes of the observation

Treatment:

Drug: Ziprasidone

haloperidol + midazolam, injection

Active Comparator group

Description:

Haloperidol plus midazolam injection, after baseline measures of agitation,allowed to be repeated twice over the 90 minutes period of observation

Treatment:

Drug: haloperidol + midazolam

haloperidol + promethazine, injection

Active Comparator group

Description:

haloperidol + promethazine injection after baseline measures of agitation, could be repeated after 30 minutes, and once more, if necessary, in the 90 minutes period of observation

Treatment:

Drug: haloperidol+promethazine

olanzapine, injection

Active Comparator group

Description:

olanzapine, 10mg, intramuscular injection after baseline measures of agitation, could be repeated twice if necessary, between the 90 minutes of observation

Treatment:

Drug: olanzapine