PEAChY-0: Pharmacological Emergency management of Agitation in Children and Young people – A randomised controlled trial of Oral medication
Trial Design:
Pragmatic, open-label, multi-centre, phase III superiority, randomised controlled trial (RCT).
Aim:
To determine in children and adolescents aged ≥7 years to <18 years with acute severe behavioural disturbance (ASBD) whether oral olanzapine is more effective than oral diazepam at achieving successful sedation at 30 minutes, without the requirement of additional medication or the presence of medication related adverse events. The Sedation Assessment Tool (SAT) will be used to score sedation and agitation levels – a SAT of ≤0 will be considered “successful sedation”.
Setting & Target:
7 PREDICT paediatric ED sites in Australia. A total of 348 participants will be recruited.
- Royal Children’s Hospital Melbourne – HREC approval obtained 5th March. Recruitment to commence on 1st June, 2021
- Monash Medical Centre
- Perth Children’s Hospital
- Women’s and Children’s Hospital, Adelaide
- Children’s Hospital at Westmead
- Gold Coast University Hospital
- Queensland Children’s Hospital
Status:
RCH Ethics approved. RCH Ethics amendment approval pending. Local governance applications at all sites will commence shortly after approval obtained. Anticipated commencement date at lead site (RCH) June 1st, 2021.
Update: The PEAChY-M: Pharmacological Emergency management of Agitation in Children and Young people – A randomised controlled trial of intraMuscular medication trial protocol has been distributed for review by the steering committee members. It will be submitted to RCH HREC in May.