Pharmacological emergency management of agitation in children and young people: protocol for a randomised controlled trial of oral medication (PEAChY-O)

Elyssia M Bourke; Meredith L Borland; Amit Kochar; Shane George; Deborah Shellshear; Shefali Jani; Kent Perkins; Doris Tham; Michael Solomon Gordon; Kate Klein; Chidambaram Prakash; Katherine Lee; Andrew Davidson; Jonathan C Knott; Simon Craig; Franz E Babl; Paediatric research in Emergency Departments International Collaborative (PREDICT)

doi:10.1136/bmjopen-2022-067433

Pharmacological emergency management of agitation in children and young people: protocol for a randomised controlled trial of oral medication (PEAChY-O)

BMJ Open. 2023 Mar 30;13(3):e067433. doi: 10.1136/bmjopen-2022-067433.

Authors

Elyssia M Bourke^{1

2

3

4}, Meredith L Borland⁵, Amit Kochar⁶, Shane George^{7

8}, Deborah Shellshear⁹, Shefali Jani^{10

11}, Kent Perkins¹², Doris Tham¹³, Michael Solomon Gordon^{14

15}, Kate Klein^{16

17}, Chidambaram Prakash¹⁸, Katherine Lee^{2

19

20}, Andrew Davidson^{3

20

21}, Jonathan C Knott^{3

22}, Simon Craig^{23

24}, Franz E Babl^{16

2

3

25}; Paediatric research in Emergency Departments International Collaborative (PREDICT)

Affiliations

¹ Emergency Research, Murdoch Children's Research Institute, Parkville, Victoria, Australia elyssia.bourke@mcri.edu.au.
² Department of Paediatrics, University of Melbourne, Parkville, Victoria, Australia.
³ Department of Critical Care, University of Melbourne, Parkville, Victoria, Australia.
⁴ Emergency Department, Grampians Health, Ballarat, Victoria, Australia.
⁵ Emergency Department, Perth Children's Hospital, Nedlands, Western Australia, Australia.
⁶ Emergency Department, Women and Children's Hospital Adelaide, Adelaide, South Australia, Australia.
⁷ Children's Critical Care Service, Gold Coast University Hospital, Southport, Queensland, Australia.
⁸ School of Medicine and Menzies Health Institute Queensland, Griffith University, Nathan, Queensland, Australia.
⁹ Emergency Department, Queensland Children's Hospital, South Brisbane, Queensland, Australia.
¹⁰ Emergency Department, Children's Hospital at Westmead, Westmead, New South Wales, Australia.
¹¹ Children's Hospital at Westmead Clinical School, The University of Sydney, Sydney, New South Wales, Australia.
¹² Emergency Department, Sunshine Coast University Hospital, Sunshine Coast, Queensland, Australia.
¹³ Paediatric Emergency Department, Western Health, Footscray, Victoria, Australia.
¹⁴ Psychological Medicine, Monash Health, Clayton, Victoria, Australia.
¹⁵ Monash University, Monash University, Clayton, Victoria, Australia.
¹⁶ Emergency Research, Murdoch Children's Research Institute, Parkville, Victoria, Australia.
¹⁷ Emergency Department, The Royal Children's Hospital Melbourne, Parkville, Victoria, Australia.
¹⁸ Department of Psychiatry, The Royal Children's Hospital Melbourne, Parkville, Victoria, Australia.
¹⁹ Clinical Epidemiology and Biostatistics (CEBU), Murdoch Children's Research Institute, Parkville, Victoria, Australia.
²⁰ Melbourne Children's Trials Centre, Murdoch Children's Research Institute, Parkville, Victoria, Australia.
²¹ Department of Anaesthesia, Royal Children's Hospital Melbourne, Parkville, Victoria, Australia.
²² Emergency Department, The Royal Melbourne Hospital City Campus, Parkville, Victoria, Australia.
²³ Department of Paediatrics, Monash University, Clayton, Victoria, Australia.
²⁴ Emergency Department, Monash Medical Centre Clayton, Clayton, Victoria, Australia.
²⁵ Emergency Department, Royal Childrens Hospital, Parkville, Victoria, Australia.

Abstract

Introduction: Acute severe behavioural disturbance (ASBD) is a condition seen with increasing frequency in emergency departments (EDs) in adults and young people. Despite the increasing number of presentations and significant associated risks to patients, families and caregivers, there is limited evidence to guide the most effective pharmacological management in children and adolescents. The aim of this study is to determine whether a single dose of oral olanzapine is more effective than a dose of oral diazepam at successfully sedating young people with ASBD.

Methods and analysis: This study is a multicentre, open-label, superiority randomised controlled trial. Young people aged between 9 years and 17 years and 364 days presenting to an ED with ASBD who are deemed to require medication for behavioural containment will be recruited to the study. Participants will be randomised in a 1:1 allocation between a single weight-based dose of oral olanzapine and oral diazepam. The primary outcome is the proportion of participants who achieve successful sedation at 1-hour post randomisation without the need for additional sedation. Secondary outcomes will include assessing for adverse events, additional medications provided in the ED, further episodes of ASBD, length of stay in the ED and hospital and satisfaction with management.Effectiveness will be determined using an intention-to-treat analysis, with medication efficacy determined as part of the secondary outcomes using a per-protocol analysis. The primary outcome of successful sedation at 1 hour will be presented as a percentage within each treatment group, with comparisons presented as a risk difference with its 95% CIs.

Ethics and dissemination: Ethics approval was received from the Royal Children's Hospital Human Research Ethics Committee (HREC/66478/RCHM-2020). This incorporated a waiver of informed consent for the study. The findings will be disseminated in a peer-reviewed journal and at academic conferences.

Trial registration number: ACTRN12621001236886.

Keywords: ACCIDENT & EMERGENCY MEDICINE; Child & adolescent psychiatry; Paediatric A&E and ambulatory care.

Publication types

Clinical Trial Protocol
Research Support, Non-U.S. Gov't

MeSH terms

Adolescent
Adult
Child
Humans
Infant, Newborn
Multicenter Studies as Topic
Olanzapine
Prunus persica*
Randomized Controlled Trials as Topic

Substances

Olanzapine