None listed
Conditions
Brief 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.
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 Agressio
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.
Sponsors
Federal University of Tocantins
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
Any subject in agitation, between 18 and 50 years of age, by bipolar or psychotic disorder by Diagnostic and Statistical Manual, Fourth Edition, Text Revision (DSM-IV-TR criteria), Overt Agitation Severity Scale Total Score (OASS) equal or under 20 and Overt Aggressive Scale (OAS) with equal or less 4 positive itens.
Exclusion criteria
Disorders due to drug abuse, organic disorder, anxiety or personality disorder by Diagnostic and Statistical Manual, Fourth Edition, Text Revision (DSM-IV-TR criteria), no concordance to research, incapable to proceed all steps and not stable clinical disease.
Outcome results
None listed