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
Randomised, controlled, open-label, multi-centre, phase III superiority effectiveness trials of: ORAL olanzapine vs ORAL diazepam and IM olanzapine vs IM droperidol.
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 – Recruitment commenced 18/10/21 for PEAChY-O and 20/10/21 for PEAChY-M.
- Monash Medical Centre – Recruitment commenced 6/6/22.
- Perth Children’s Hospital – Recruitment commenced 23/6/22.
- Women’s and Children’s Hospital, Adelaide – Recruitment commenced 21/5/22.
- Children’s Hospital at Westmead – RGO approval obtained 30/5/22 for PEAChY-O
- Gold Coast University Hospital – RGO approval obtained 25/10/21 for PEAChY-O and PEAChY-M 27/7/22.
- Queensland Children’s Hospital – awaiting PHAs.
- Royal Children’s Hospital: 46
- Women’s and Children’s Hospital, Adelaide:12
- Monash Medical Centre: 6
- Perth Children’s Hospital:1
- Royal Children’s Hospital: 15
- Women’s and Children’s Hospital, Adelaide: 3
- Monash Medical Centre: 1
- Perth Children’s Hospital: 3
- First annual site visits planned for August/September for recruiting sites.