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

Not Applicable

Completed

• Conditions: Psychomotor Agitation
• Interventions: Drug: Ziprasidone; Drug: haloperidol + midazolam; Drug: haloperidol+promethazine; Drug: olanzapine

• Registration Number: NCT01485692
• Lead Sponsor: University of Sao Paulo

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-02
• Study Start: 2009-02
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Study First Submitted: 2011-11-28
• Study First Submitted QC: 2011-12-01
• Last Update Submitted: 2011-12-01
• Study First Posted: 2011-12-05
• Last Update Posted: 2011-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ziprasidone injection	Ziprasidone	ziprasidone injection after baseline measures of agitation, could be repeated twice, if necessary, between the 90 minutes of the observation
haloperidol + midazolam, injection	haloperidol + midazolam	Haloperidol plus midazolam injection, after baseline measures of agitation,allowed to be repeated twice over the 90 minutes period of observation
haloperidol + promethazine, injection	haloperidol+promethazine	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	olanzapine	olanzapine, 10mg, intramuscular injection after baseline measures of agitation, could be repeated twice if necessary, between the 90 minutes of observation

Primary Outcome Measures

Name	Time	Method
Reduction in the agitation score	90 minutes	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.

Secondary Outcome Measures

Name	Time	Method
Adverse effects	12,24 hours after baseline	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.

Trial Locations

Locations (1)

Hospital das Clinicas da Faculdade de Medicina de Ribeirão Preto, USP; 🇧🇷 Ribeirão Preto, São Paulo, Brazil