PEAChY-0: Pharmacological Emergency management of Agitation in Children and Young people – A randomised controlled trial of Oral medication
PEAChY-M: Pharmacological Emergency management of Agitation in Children and Young people – A randomised controlled trial of IntraMuscular medication
Trial Designs:
Randomised, controlled, open-label, multi-centre, phase III superiority effectiveness trials of: ORAL olanzapine vs ORAL diazepam and IM olanzapine vs IM droperidol.
Aim:
To determine in children and adolescents aged ≥9 years to <18 years with acute severe behavioural disturbance (ASBD) whether oral olanzapine is more effective than oral diazepam and whether IM olanzapine is more effective than IM droperidol at achieving successful sedation at 1 hour post randomisation, without the requirement of additional medication. 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 in each trial.
- Royal Children’s Hospital Melbourne – HREC amendment approval for PEAChY-O obtained 26th August. Recruitment commenced 18th October, 2021. HREC approval for PEAChY-M obtained 6th September, 2021. Recruitment commenced 20th October, 2021.
- Monash Medical Centre
- Perth Children’s Hospital
- Women’s and Children’s Hospital, Adelaide – RGO approval obtained 2nd November, 2021
- Children’s Hospital at Westmead
- Gold Coast University Hospital – RGO approval obtained 25th October, 2021
- Queensland Children’s Hospital
PEAChY-O Status: Six participants enrolled.
PEAChY-M Status: Two participants enrolled.
Update:
- Ongoing review of recruitment processes and documents continues at RCH.
- Education to commence recruitment at participating sites anticipated to commence in February, 2022.