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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01485692
Other study ID # UE0001
Secondary ID
Status Completed
Phase N/A
First received November 28, 2011
Last updated December 1, 2011
Start date February 2009
Est. completion date March 2011

Study information

Verified date February 2009
Source University of Sao Paulo
Contact n/a
Is FDA regulated No
Health authority Brazil: Ethics CommitteeBrazil: National Committee of Ethics in Research
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date March 2011
Est. primary completion date March 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 55 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
haloperidol+promethazine
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 + midazolam
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
olanzapine, 10mg, intramuscular injection, after baseline measures of agitation, could be repeated twice, if necessary, between the 90 minutes of observation
Ziprasidone
ziprasidone, 10 mg, intramuscular injection after baseline measures of agitation, could be repeated twice, if necessary, between the 90 minutes period of observation

Locations

Country Name City State
Brazil Hospital das Clinicas da Faculdade de Medicina de Ribeirão Preto, USP Ribeirão Preto São Paulo

Sponsors (1)

Lead Sponsor Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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 Yes
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