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Trial registered on ANZCTR


Registration number
ACTRN12621001238864p
Ethics application status
Submitted, not yet approved
Date submitted
23/08/2021
Date registered
13/09/2021
Date last updated
13/09/2021
Date data sharing statement initially provided
13/09/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
PEAChY-M
Pharmacological Emergency management of Agitation in Children and Young people: a randomised controlled trial of intraMuscular medication
Scientific title
PEAChY-M
Pharmacological Emergency management of Agitation in Children and Young people: a randomised controlled trial of the effectiveness of intraMuscular (IM) medication for the management of acute severe behavioural disturbance.
Secondary ID [1] 304784 0
Nil known
Universal Trial Number (UTN)
U1111-1268-9679
Trial acronym
PEAChY-M
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
acute severe behavioural disturbance 322847 0
Condition category
Condition code
Emergency medicine 320427 320427 0 0
Other emergency care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
PEAChY-M is a randomised controlled trial which will compare the effectiveness of intramuscular (IM) olanzapine [arm one] to IM droperidol [arm two] for the management of paediatric acute severe behavioural disturbance occurring in the emergency department (ED).
ASBD will be determined by confirming the participant has a Sedation Assessment Tool (SAT) score of +1 or greater.
Dosing will be based on weight.
This is an open label study.
The trial medication will be provided by the clinical staff caring for the participant in the ED.
Only one dose will be provided as part of the PEAChY-M study.
No modifications to the doses or the medications provided will be allowed.

Arm One:
Participants will receive 5mg IM olanzapine if they weigh <40kg or 10mg if they weigh 40kg or greater.
Intervention code [1] 321165 0
Treatment: Drugs
Comparator / control treatment
Arm Two:
Participants will receive 5mg IM droperidol if they weigh <40kg or 10mg if they weigh 40kg or greater.
Control group
Active

Outcomes
Primary outcome [1] 328268 0
The primary outcome will be successful sedation without the requirement for additional sedation 1 hour post randomisation.
Successful sedation will be assessed using the Sedation Assessment Tool Score.
Timepoint [1] 328268 0
1 hour post randomisation.
Secondary outcome [1] 398284 0
Medication related adverse events reported from randomisation until measurement of the primary outcome.

Medication related adverse events will be recorded on prospective case report forms by clinical staff and the participant's medical record will be reviewed retrospectively by research staff to determine if any adverse events were noted during the time period specified.
Timepoint [1] 398284 0
From randomisation until the primary outcome is measured (1 hour following randomisation).
Secondary outcome [2] 398285 0
Medication related adverse events reported from after the measurement of the primary outcome until the participant is discharged from hospital.

The participant's medical record will be reviewed retrospectively by research staff to determine if any adverse events were noted during the time period specified.
Timepoint [2] 398285 0
From 1 hour post randomisation (immediately after measurement of primary outcome) until the participant is discharged from hospital.
Secondary outcome [3] 398286 0
Further episodes of violent and acute behavioural disturbance in the ED after randomisation until discharge from the ED.

The participant's medical records will be reviewed retrospectively by research staff to determine if any further episodes of violence or behavioural disturbance were noted.
Timepoint [3] 398286 0
From randomisation until the participant leaves the ED.
Secondary outcome [4] 398287 0
Injuries to staff from randomisation until the participant's discharge from the ED.
For example: soft tissue injuries sustained from being punched or kicked.

The participant's medical records will be reviewed retrospectively by research staff to determine if any injuries to staff were documented. Research staff will also review the hospital's incident management recording system to identify if any injuries were reported during the participant's ED stay.
Timepoint [4] 398287 0
From randomisation until the participant leaves the ED.
Secondary outcome [5] 398288 0
Injuries to participants and/or their parents or guardians from randomisation until the participant's discharge from the ED.
For example: injuries related to physical or mechanical restraints inclusive of skin erythema or bruising.

The participant's medical records will be reviewed retrospectively by research staff to determine if any injuries to participants and/or their parents or guardians were documented.
Timepoint [5] 398288 0
From randomisation until the participant leaves the ED.
Secondary outcome [6] 398289 0
Length of stay in the ED (from the time of randomisation).

The participant's medical record will be reviewed to determine the time at which the participant was discharged from the ED.
Timepoint [6] 398289 0
From randomisation until the participant leaves the ED.
Secondary outcome [7] 398290 0
Length of stay in hospital (from the time of randomisation).

The participant's medical record will be reviewed to determine the time at which the participant was discharged from the hospital.
Note: this will only apply to participants who were admitted to the hospital.
Timepoint [7] 398290 0
From the time of randomisation until the participant leaves the hospital.
Secondary outcome [8] 398291 0
Disposition upon discharge from the ED.
For example: discharged home or admitted to a mental health unit.

The participant's medical record will be reviewed to determine their disposition upon discharge from the ED.
Timepoint [8] 398291 0
Measured at the time the participant is discharged from the ED.
Secondary outcome [9] 398292 0
Staff, participant and carer satisfaction with the management provided after 1 hour post randomisation but before the participant is discharged from the ED.

A satisfaction survey will be provided to each of the three groups outlined above. This survey will assess how satisfied the staff member, participant and/or carer was with how the medication provided helped them feel calm, how fast it worked and how well it was tolerated on a three point Likert Scale.
Timepoint [9] 398292 0
To be assessed as soon as practical after the primary outcome measurement is undertaken but must be measured before the participant is discharged from ED.
Secondary outcome [10] 398293 0
Healthcare resource use and costs incurred from time of randomisation until ED discharge.

The use and costs incurred will be determined through an audit of the participant's medical records to assist in determining the following factors:
number of ED staff members involved in the participant's care
the participant's length of stay in ED
amount of time requiring high-dependency care in the ED
cost of medication provided
cost related to damage to property and/or ED equipment
cost of the participant's hospital stay
cost of associated side effects or adverse events experienced
Timepoint [10] 398293 0
Measured from the time of randomisation until the participant is discharged from the ED.
Secondary outcome [11] 398294 0
Healthcare resource use and costs incurred from time of randomisation until hospital discharge.

The use and costs incurred will be determined through an audit of the participant's medical records to assist in determining the following factors:
number of ED staff members involved in the participant's care
amount of time requiring high-dependency care in the ED
cost of medication provided
cost related to damage to property and/or ED equipment
the participant's length of stay in the hospital
cost of the participant's hospital stay
cost of associated side effects or adverse events experienced whilst in the hospital
Timepoint [11] 398294 0
Measured from the time of randomisation until the participant is discharged from the hospital.
Secondary outcome [12] 398295 0
Clinician assessment of whether “successful sedation” was achieved.
This will be assessed at 1 hour post randomisation.
In addition to the objective primary outcome, this will provide the clinician caring for the participant the opportunity to provide a binary assessment of whether they believe successful sedation has been achieved using a yes/no scale.
Timepoint [12] 398295 0
Measured at the time of the primary outcome (1 hour post randomisation).
Secondary outcome [13] 398296 0
Whether a participant is administered their randomised medication or not.

This information will be documented on the prospective case report form by clinical staff.
Timepoint [13] 398296 0
Measured at 1 hour post randomisation.
Secondary outcome [14] 398297 0
Whether a participant is administered their prescribed weight-based dose or not.

This information will be documented on the prospective case report form by clinical staff. In addition, the participant's medical record will be reviewed to determine the dose provided.
Timepoint [14] 398297 0
Measured at 1 hour post randomisation.
Secondary outcome [15] 399825 0
To describe the length of stay in the ED (from time of triage).

The participant's medical record will be reviewed and this information will be captured retrospectively by research staff.
Timepoint [15] 399825 0
From time of triage until the participant is discharged from the ED.
Secondary outcome [16] 399826 0
To describe the length of stay in the hospital (from time of triage).

The participant's medical record will be reviewed and this information will be captured retrospectively by research staff.
Timepoint [16] 399826 0
From time of triage until the participant is discharged from hospital.

Eligibility
Key inclusion criteria
1. Age between 9 years and 17 years and 364 days.
2. SAT score of +1 or greater as determined by the ED clinician (i.e. patient deemed to be in a state of ASBD).
3. Concerted attempts at non-pharmacological management of the participant’s ASBD have failed.
4. ED clinician determines that medication is required to assist with management of the participant’s ASBD and IM medication is thought to be the most appropriate route of administration.
Minimum age
9 Years
Maximum age
17 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Known, documented or reported allergy or previous serious side effect to either olanzapine or droperidol.
2. Known, documented or reported non-response to either olanzapine or droperidol (e.g. in the medical record, a behavioural management plan [or similar] or by parent / guardian report).
3. Accompanying parent / guardian requests or refuses either olanzapine or droperidol.
4. Obvious reversible aetiology for agitation that has been identified and not yet treated (e.g.: hypotension, hypoxia, hypoglycaemia).
5. Known pregnancy.
6. Known long QT syndrome.
7. Participants who have been enrolled in PEAChY-O during this ED admission (previous enrolment is not an exclusion criteria).
8. Participants who have been enrolled in PEAChY-M during a prior ED admission.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be concealed using sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated block randomised lists will be created by an independent statistician stratified by site using variable block sizes.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
N/A
Phase
Phase 3
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Assuming conservatively that 60% of participants reach successful sedation without the requirement for additional medication at 1 hour post randomisation (primary outcome) in the IM droperidol group, 165 participants would be required in each arm to provide 80% power to detect a 15% increase in the percentage with a positive outcome in the IM olanzapine group (to 75%), based on a two-sided test with alpha=0.05. Given the paucity of data, determining the expected difference from previous peer reviewed publications is challenging. However, a 15% increase in the number of participants successfully sedated at 1 hour would be considered clinically important.
In order to allow for a 5% loss to follow-up (which is a conservative estimate given the short time frame of the primary outcome), we aim to recruit a total of 348 participants to this trial (approximately 174 per group).
The main objectives of the trial – those relating to effectiveness – will be analysed using an intention to treat analysis. All participants, regardless of whether or not they are administered the medication they are randomised to, will be included in this analysis.
As part of this study there are also a number of objectives regarding the efficacy of the interventions. The efficacy objectives will be assessed using a per protocol analysis including only participants who are administered the medication to which they have been randomised within 30 minutes from randomisation.
Baseline and demographic characteristics will be summarised by randomised group in both the intention-to-treat and per protocol populations as means and standard deviations (SD) for continuous variables (or medians and interquartile rage for non-normal variables) and number and percentage for categorical variables.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC
Recruitment hospital [1] 20284 0
The Royal Childrens Hospital - Parkville
Recruitment hospital [2] 20285 0
Monash Children’s Hospital - Clayton
Recruitment hospital [3] 20286 0
Perth Children's Hospital - Nedlands
Recruitment hospital [4] 20287 0
Womens and Childrens Hospital - North Adelaide
Recruitment hospital [5] 20288 0
Gold Coast University Hospital - Southport
Recruitment hospital [6] 20289 0
Queensland Children's Hospital - South Brisbane
Recruitment hospital [7] 20290 0
The Children's Hospital at Westmead - Westmead
Recruitment postcode(s) [1] 35025 0
3052 - Parkville
Recruitment postcode(s) [2] 35026 0
3168 - Clayton
Recruitment postcode(s) [3] 35027 0
6009 - Nedlands
Recruitment postcode(s) [4] 35028 0
5006 - North Adelaide
Recruitment postcode(s) [5] 35029 0
4215 - Southport
Recruitment postcode(s) [6] 35030 0
4101 - South Brisbane
Recruitment postcode(s) [7] 35031 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 309157 0
Government body
Name [1] 309157 0
Medical Research Futures Fund Million Minds Mission administered through the Department of Health
Address [1] 309157 0
Department of Health
GPO Box 9848
Canberra ACT 2601
Australia
Country [1] 309157 0
Australia
Funding source category [2] 309472 0
Government body
Name [2] 309472 0
Western Australia Child Research Fund
Address [2] 309472 0
PO Box 8172
Perth Business Centre
Perth WA 6849
Australia
Country [2] 309472 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Murdoch Children's Research Institute (MCRI)
Address
Royal Children's Hospital
50 Flemington Road, Parkville
Victoria 3052
Australia
Country
Australia
Secondary sponsor category [1] 310676 0
None
Name [1] 310676 0
Address [1] 310676 0
Country [1] 310676 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 309021 0
Royal Children's Hospital Research Governance and Ethics Committee
Ethics committee address [1] 309021 0
Royal Children's Hospital
50 Flemington Road, Parkville
Victoria 3052
Ethics committee country [1] 309021 0
Australia
Date submitted for ethics approval [1] 309021 0
28/06/2021
Approval date [1] 309021 0
Ethics approval number [1] 309021 0
HREC/69948/RCHM-2021

Summary
Brief summary
Acute severe behavioural disturbance (ASBD) is an emergency situation where a patient experiences severe agitation or aggression.
One of the common strategies used to manage those presenting to the emergency department (ED) with ASBD is the provision of medications. Medications assist in allowing the young person to gain control over their behaviour. In most instances, oral medications are used. For a small proportion of young people with ASBD, their emotional dysregulation is so extreme that they are unable or unwilling to accept oral medication and, therefore, IM medication is required to de-escalate their behaviour.
In individuals less than 18 years of age, there is no evidence available to guide doctors about which medications are the most effective, despite them being commonly used to manage ASBD. It is also not known how well these medications are tolerated by young people.
Therefore, the primary aim of this study is to determine whether, in children and adolescents with ASBD, IM olanzapine is more effective than IM droperidol at achieving successful sedation (i.e.: a state of calm) at 1 hour after randomisation. These medications were chosen as they are the two of the most commonly used medications in Australia.
This study will be a randomised, open label, multi-centre effectiveness trial which will enrol young people aged 9 to 17 and 364 days presenting to participating EDs with ASBD.
We hope to determine which medication is most effective and to assess the side effects of these medications.
We hypothesise that 15% more children will achieve successful sedation 1 hour after randomisation to olanzapine compared to those children who were randomised to droperidol.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 112674 0
Prof Franz Babl
Address 112674 0
Emergency Research Group
Murdoch Children's Research Institute
Royal Children's Hospital
50 Flemington Road, Parkville
Victoria 3052
Country 112674 0
Australia
Phone 112674 0
+61 3 9936 6635
Fax 112674 0
+61 3 9345 5938
Email 112674 0
franz.babl@rch.org.au
Contact person for public queries
Name 112675 0
Prof Franz Babl
Address 112675 0
Emergency Research Group
Murdoch Children's Research Institute
Royal Children's Hospital
50 Flemington Road, Parkville
Victoria 3052
Country 112675 0
Australia
Phone 112675 0
+61 3 9936 6635
Fax 112675 0
+61 3 9345 5938
Email 112675 0
franz.babl@rch.org.au
Contact person for scientific queries
Name 112676 0
Prof Franz Babl
Address 112676 0
Emergency Research Group
Murdoch Children's Research Institute
Royal Children's Hospital
50 Flemington Road, Parkville
Victoria 3052
Country 112676 0
Australia
Phone 112676 0
+61 3 9936 6635
Fax 112676 0
+61 3 9345 5938
Email 112676 0
franz.babl@rch.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results