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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ziprasidone injection | Active Comparator | ziprasidone injection after baseline measures of agitation, could be repeated twice, if necessary, between the 90 minutes of the observation |
|
| haloperidol + midazolam, injection | Active Comparator | Haloperidol plus midazolam injection, after baseline measures of agitation,allowed to be repeated twice over the 90 minutes period of observation |
|
| haloperidol + promethazine, injection | Active Comparator | 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 |
|
| olanzapine, injection | Active Comparator | olanzapine, 10mg, intramuscular injection after baseline measures of agitation, could be repeated twice if necessary, between the 90 minutes of observation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| haloperidol+promethazine | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Celia Mantovani, MD | University of Sao Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital das Clinicas da Faculdade de Medicina de Ribeirão Preto, USP | Ribeirão Preto | São Paulo | 14048-900 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23609398 | Derived | Mantovani C, Labate CM, Sponholz A Jr, de Azevedo Marques JM, Guapo VG, de Simone Brito dos Santos ME, Pazin-Filho A, Del-Ben CM. Are low doses of antipsychotics effective in the management of psychomotor agitation? A randomized, rated-blind trial of 4 intramuscular interventions. J Clin Psychopharmacol. 2013 Jun;33(3):306-12. doi: 10.1097/JCP.0b013e3182900fd6. |
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| ID | Term |
|---|---|
| D011595 | Psychomotor Agitation |
| D000374 | Aggression |
| ID | Term |
|---|---|
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D011596 | Psychomotor Disorders |
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| ID | Term |
|---|---|
| D006220 | Haloperidol |
| D008874 | Midazolam |
| D000077152 | Olanzapine |
| C092292 | ziprasidone |
| ID | Term |
|---|---|
| D002090 | Butyrophenones |
| D007659 | Ketones |
| D009930 | Organic Chemicals |
| D001569 | Benzodiazepines |
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| haloperidol + midazolam | Drug | 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 | Drug | olanzapine, 10mg, intramuscular injection, after baseline measures of agitation, could be repeated twice, if necessary, between the 90 minutes of observation |
|
| Ziprasidone | Drug | ziprasidone, 10 mg, intramuscular injection after baseline measures of agitation, could be repeated twice, if necessary, between the 90 minutes period of observation |
|
| D019954 |
| Neurobehavioral Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000096762 | Aberrant Motor Behavior in Dementia |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D012919 | Social Behavior |
| D001552 |
| Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |