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

Study Overview
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Brief Summary
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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.

Official Title
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Safety and Efficacy of Four Intramuscular Interventions for the Management of Acute Psychomotor Agitation

Conditions
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Psychomotor Agitation

Intervention / Treatment
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* Drug: haloperidol+promethazine
* Drug: haloperidol + midazolam
* Drug: olanzapine
* Drug: Ziprasidone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ziprasidone injection<br>ziprasidone injection after baseline measures of agitation, could be repeated twice, if necessary, between the 90 minutes of the observation | Drug: Ziprasidone<br>* ziprasidone, 10 mg, intramuscular injection after baseline measures of agitation, could be repeated twice, if necessary, between the 90 minutes period of observation<br>|
| Active Comparator: haloperidol + midazolam, injection<br>Haloperidol plus midazolam injection, after baseline measures of agitation,allowed to be repeated twice over the 90 minutes period of observation | Drug: haloperidol + midazolam<br>* 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<br>|
| Active Comparator: haloperidol + promethazine, injection<br>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 | Drug: haloperidol+promethazine<br>* 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<br>|
| Active Comparator: olanzapine, injection<br>olanzapine, 10mg, intramuscular injection after baseline measures of agitation, could be repeated twice if necessary, between the 90 minutes of observation | Drug: olanzapine<br>* olanzapine, 10mg, intramuscular injection, after baseline measures of agitation, could be repeated twice, if necessary, between the 90 minutes of observation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Violence, Aggression, Psychiatric emergencies, Psychomotor agitation, Violent patient