Pharmacological Emergency management of Agitation in Children and Young people (PEAChY)

Acute severe behavioural disturbance (ASBD) is any behaviour, including agitation, violence, self harm or delirium. This behaviour results in a risk of harm to the person experiencing it, to staff and to others and it requires medical intervention to prevent and/or reduce the risk of this harm. Children and adolescents with ASBD are presenting more frequently to Australian EDs over the past decade. These presentations pose a significant physical and psychological risk to the patient and those involved in caring for them within the ED.

Presentations of ASBD are managed in a step-wise manner. Non-pharmacological strategies are employed first if appropriate. If these strategies fail and the child still poses a significant risk to themselves or others, medication will be provided to assist the child to gain control over their behaviour. This usually involves offering oral medication. In a small percentage of children who are extremely agitated, parenteral medication will be required.

There is limited evidence to guide which are the most efficacious medications (oral and parenteral) for the management of ASBD in the paediatric population. Current practice has been extrapolated from the adult ASBD literature.

We therefore propose to undertake the PEAChY study to determine which medication is the most effective for the management of this condition.

Two separate but linked studies will be undertaken. PEAChY-O (Oral) will assess the effectiveness of oral medications for de-escalating ASBD and PEAChY-M (IM) will assess the effectiveness of intramuscular medications.

As well as determining which medication is the most effective, we will monitor the safety and side effect profiles of each medication.

Study design

Two multi centre, parallel group, single-blinded, randomised controlled trials will be undertaken.

Chief Investigators

Elyssia Bourke (Murdoch Children’s Research Institute)
Simon Craig (Monash Health)
Andrew Davidson (Royal Children’s Hospital)
Jonathan Knott (Royal Melbourne Hospital; University of Melbourne)
Kate Lee (Murdoch Children’s Research Institute)
Kate Klein (Murdoch Children’s Research Institute)
Franz Babl (Royal Children’s Hospital; Murdoch Children’s Research Institute)

Timeframe

2020 – 2025

Funding

Medical Research Futures Fund (MRFF) Million Minds Grant

Site locations

  • Royal Children’s Hospital, Melbourne (PI Elyssia Bourke & Kate Klein)
  • Monash Children’s Hospital, Melbourne (PI Simon Craig)
    (Further 5 sites TBC)

Sample

Oral Medication – 694 total participants aged <18 years of age requiring oral medication for ASBD
IM medication – 556 total participants aged < 18 years of age with ASBD requiring IM medication for ASBD

Clinical trials registration

To be confirmed

Contact

elyssia.bourke@mcri.edu.au
franz.babl@rch.org.au