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

Abstract

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. In individuals less than 18 years of age, there is no evidence available to guide doctors about which medications are the most efficacious, 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, oral olanzapine is more effective than oral diazepam at achieving successful sedation (i.e.: a state of calm) at 1 hour after randomisation. These medications were chosen as they are the two most commonly used medication 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 diazepam.