Rapid tranquillization of agitated or aggressive patients in an in-patient psychiatric setting: Pragmatic randomized double-blind trial of intramuscular olanzapine versus intramuscular haloperidol

Dr Varuni de Silva,0 个研究点目标入组 134 人开始时间: 待定最近更新: 2024年8月20日

适应症

试验速览

暂无简介。

•1. Age 18-65 years
•2. Patients admitted with acute agitation or already hospitalized and become agitated with a total score of Positive and Negative Symptoms Scale-Excited Component (PANSS-EC) >= 14 or at least one item with a score of >= 4 (If this requirement is not met at baseline and rapid tranquilization has not been given the patient could be re-evaluated in the subsequent 24 hours)
•3. Clear indication of intramuscular route of administration according to the attending doctor because of agitation, aggression, or violent behaviour
•4. Presence of good physical health confirmed by medical history and physical examination

•1. Agitation primarily due to acute intoxication
•2. History of drug or alcohol dependence in the previous 8 weeks
•3. Use of benzodiazepines / other hypnotics/ oral or intramuscular antipsychotic in the 4 hours before study intervention
•4. Use of depot antipsychotic within one dose interval before study intervention
•5. Clinically significant acute or chronic pulmonary disease/ clinically significant hepatic, renal, gastroenterological, cardiovascular, neurological or hematological disease
•6. Pregnant or lactating females

发起方

Dr Varuni de Silva,