PEAChY-M Pharmacological Emergency management of Agitation in Children and Young people: a randomised controlled trial of intraMuscular medication

Acute severe behavioural disturbance (ASBD) is an emergency situation where a patient experiences severe agitation or aggression. One of the common strategies used to manage those presenting to the emergency department (ED) with ASBD is the provision of medications. Medications assist in allowing the young person to gain control over their behaviour. In most instances, oral medications are used. For a small proportion of young people with ASBD, their emotional dysregulation is so extreme that they are unable or unwilling to accept oral medication and, therefore, IM medication is required to de-escalate their behaviour. In individuals less than 18 years of age, there is no evidence available to guide doctors about which medications are the most effective, despite them being commonly used to manage ASBD. It is also not known how well these medications are tolerated by young people. Therefore, the primary aim of this study is to determine whether, in children and adolescents with ASBD, IM olanzapine is more effective than IM droperidol at achieving successful sedation (i.e.: a state of calm) at 1 hour after randomisation. These medications were chosen as they are the two of the most commonly used medications in Australia. This study will be a randomised, open label, multi-centre effectiveness trial which will enrol young people aged 9 to 17 and 364 days presenting to participating EDs with ASBD. We hope to determine which medication is most effective and to assess the side effects of these medications. We hypothesise that 15% more children will achieve successful sedation 1 hour after randomisation to olanzapine compared to those children who were randomised to droperidol.