A randomised controlled trial for the management of acute behavioural disturbance comparing haloperidol versus droperidol for the most effective sedation in psychiatric intensive care patients.

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Aggressive behaviour related to acute psychosis is an ever present problem in emergency admissions to psychiatric wards and intensive care units. It can lead to patient harm and prolonged distress, injury to staff and/or other patients and damage to hospital property if the situation is not rapidly controlled. Intramuscular sedation is commonly used to manage these patients when all other attempts including verbal de-escalation and oral sedation have failed. The most commonly used drugs for this purpose have been benzodiazepines and antipsychotics given by the intramuscular route, mainly midazolam and haloperidol. Intramuscular midazolam has proven to be unpredictable and can lead to both over-or under sedation of the acutely disturbed patient. It has a significant adverse effect profile due to over-sedation with respiratory depression and/or loss of airways patency. Conversely it is associated with under sedation when used to sedate patients with benzodiazepine tolerance. For this reason we no longer recommend the use of intramuscular midazolam for rapid sedation of acute behavioural disturbance in the emergency department. Haloperidol is also commonly used in this patient cohort but is associated with a high risk of extrapyramidal side effects and a risk of QT prolongation with associated Torsades de Pointes. Droperidol is less commonly used but is a highly sedative antipsychotic medication that is rarely associated with complications. This study aims to compare the effectiveness of droperidol compared to haloperidol for the sedation of aggressive patients with acute functional psychotic symptoms in a randomised controlled trial. The study is designed to assess both the speed of onset, effectiveness, and adverse effect profile of both agents. AIMS: This study aims to: 1. Compare the effectiveness of intramuscular droperidol to intramuscular haloperidol for sedation of aggressive patients with acute behavioural disturbance based on: a. the time until sedation occurs; b. the requirements for additional sedation. 2. Investigate the safety of intramuscular droperidol compared to haloperidol 3. Determine the practicality and effectiveness of introducing a sedation protocol into the psychiatric intensive care setting for patients with acute behavioural disturbance with related violent and aggressive symptoms; HYPOTHESES: The specific hypotheses of the study are that: 1. The time to sedation with intramuscular droperidol is shorter than intramuscular haloperidol; 2. Initial sedation with droperidol will require less additional sedation attempts compared to haloperidol; 3. Droperidol will result in a smaller proportion of extrapyramidal side-effects compared to haloperidol;