Rapid tranquillisation for agitated patients in emergency psychiatric rooms.
Rapid tranquillisation for agitated patients in emergency psychiatric rooms: a randomised trial of olanzapine, ziprasidone, haloperidol plus promethazine, haloperidol plus midazolam and haloperidol alone for reduction in agitation.
Federal University of Tocantins
150 participants
Jan 18, 2010
Interventional
Conditions
Summary
Agitated or violent behavior, mostly as a result of serious mental illness and substance misuse constitutes around 10% of the reasons for use of emergency services. The drugs used in such situations should calm patients safely and swiftly. Guidelines, however, are usually statements of consensus and differ on which drugs to use. Some of the new generation antipsychotics are really not only for oral use but also for parenteral use such as olanzapine and ziprasidone. These medications means an advance in rapid manage of acute behavior alterations. By the way, knowledge about antipsychotics profile in agitation and aggressive behavior is limited and few studies compare several drugs in rapid tranquilization. The objective of this study is to compare five options of parenteral (intramuscular) antipsychotics, including olanzapine, ziprasidone, haloperidol, haloperidol plus promethazine and haloperidol plus midazolam as first medication in agitation.
Eligibility
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Interventions
One hundred fifty subjects in agitation secundary to psychotic or bipolar disorder will be selected randomly for one of five rapid tranquilization options by intramuscular administration at baseline: olanzapine 10mg, ziprasidone 20mg, haloperidol 5mg plus midazolam 15mg, haloperidol 5mg plus promethazine 50mg and haloperidol 5mg alone. They will be revaluated after one hour, two hours, four hours, six hours and twelve hours after first medication by Overt Agitation Severity Scale, Overt Agression Scale and Ramsay Sedation Scale after 1 hours, 2 hours, 4 hours, 6 hours and 12 hours after first administration. When necessary aditional medication haloperidol 5mg plus promethazine 50mg will be used for all groups. This protocol will used for 12 hours.
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ACTRN12610000033044