PEAChY-M Study
- Project status: Active
Research area: Clinical Sciences > Emergency
PEAChY-M: Pharmacological Emergency Management of Agitation in Children and Young People - A Randomised Controlled Trial of IntraMuscular Medication
This clinical drug trial aims to determine whether intramuscular (IM) olanzapine is more effective than IM droperidol for the management of acute severe behavioural disturbance (ASBD) in children and adolescents presenting to Emergency Departments (EDs).
This clinical drug trial aims to determine whether intramuscular (IM) olanzapine is more effective than IM droperidol for the management of acute severe behavioural disturbance (ASBD) in children and adolescents presenting to Emergency Departments (EDs).
This clinical drug trial aims to determine whether intramuscular (IM) olanzapine is more effective than IM droperidol for the management of acute severe behavioural disturbance (ASBD) in children and adolescents presenting to Emergency Departments (EDs).
Overview
PEAChY-M is a clinical drug trial. A total of 348 children aged nine (9) years to less than 18 years of age with acute severe behavioural disturbance (ASBD) in 10 paediatric Emergency Departments (EDs) around Australia will be enrolled.
Purpose
A number of randomised controlled trials (RCTs) investigating the pharmacological management of ASBD have been undertaken in the adult population. However, there is a dearth of evidence in the paediatric population – no RCTs or systematic reviews have been undertaken. As a result, with paediatric presentations of ASBD increasing every year, the findings from the adult RCTs have been extrapolated to this group. This is concerning, as the causes of ASBD in children are notably different than in adults. The adult medications currently being used in children are also likely to vary in their efficacy and side effect profiles within the paediatric population.
Additionally, ASBD presentations have significant impacts on ED resources. However, the degree of resource use and the associated costs incurred have not been studied in the paediatric ASBD setting.
The PEAChY-M study aims to provide the Australasian clinical community with clear information on the most effective intramuscular medication for use in paediatric ASBD, as well as data related to healthcare resource use and costs for paediatric ASBD presentations to EDs.
Please note: This project is not open for participation by the general public.
Information for clinicians
A number of randomised controlled trials (RCTs) investigating the pharmacological management of acute severe behavioural disturbance (ASBD) have been undertaken in the adult population. However, there is a dearth of evidence in the paediatric population—no RCTs or systematic reviews have been undertaken.
As a result, with paediatric presentations of ASBD increasing every year, the findings from the adult RCTs have been extrapolated to this group. This is concerning, as the causes of ASBD in children are notably different from adults. The adult medications currently being used in children are also likely to vary in their effectiveness and side effect profiles within the paediatric population.
ASBD presentations have significant impacts on ED resources. However, resource use and the associated costs incurred have not been studied in the paediatric ASBD setting.
The PEAChY-M study aims to provide the Australasian clinical community with clear information on the most effective intramuscular medication for paediatric ASBD, as well as data related to healthcare resource use for and costs of paediatric ASBD presentations to ED.
The research team has undertaken an electronic survey (unpublished) of Australian adult and paediatric emergency physicians to better understand current clinical practice and clinician preferences in relation to treatment of paediatric ASBD.
We received 218 responses. Because of these findings, in combination with state-based guidelines and the side-effect profiles of each medication, the study team selected IM olanzapine and IM droperidol for comparison, with 53.2% and 86.7% of respondent’s requesting they be included in the trial, respectively.
Research team
Role | Team member |
---|---|
Lead Researcher & Principal Investigator PhD Candidate |
Dr Elyssia Bourke |
Research Coordinator | Ms Kate Klein |
Chief Principal Investigator Australian Trial Steering Committee |
Prof Franz Babl |
Australian Trial Steering Committee | Dr Simon Craig |
Australian Trial Steering Committee | Prof Katherine Lee |
Australian Trial Steering Committee | A/Prof Jonathan Knott |
Australian Trial Steering Committee | Prof Andrew Davidson |
Australian Trial Steering Committee | Dr Meredith Borland |
Australian Trial Steering Committee | Dr Shane George |
Australian Trial Steering Committee | Dr Amit Kochar |
Australian Trial Steering Committee | Dr Shefali Jani |
Australian Trial Steering Committee | Dr Deborah Shellshear |
Australian Trial Steering Committee | Dr Doris Tham |
Australian Trial Steering Committee | Dr Kent Perkins |
Australian Trial Steering Committee | A/Prof Michael Gordon |
Australian Trial Steering Committee | Ms Catherine Wilson |
Australian Trial Steering Committee | Dr Amanda Williams |
Australian Trial Steering Committee | Dr Sharon O'Brien |
Australian Trial Steering Committee | Dr Marietta John-White |
Sponsors
Thanks to our sponsors, the Melbourne Children's Trial Centre (MCTC) and Murdoch Children’s Research Institute. Thanks also to our group of consumer representatives for their input.
Funding
The PEAChY-M Study is funded through The National Health and Medical Research Council (NHMRC).
Contact us
PEAChY-M Study
Murdoch Children's Research Institute
The Royal Children's Hospital
50 Flemington Road
Parkville VIC 3052
Australia
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