PEAChY-O: Pharmacological Emergency Management of Agitation in Children and Young People: A Randomized Controlled Trial of Oral Medication - 15/02/25

Doi : 10.1016/j.annemergmed.2025.01.007

Elyssia M. Bourke, MPH ^1,^2,^3,^4,^5,^6,^⁎ , Amit Kochar, MD ^7,⁸, Deborah Shellshear, MBBS ⁹, Meredith L. Borland, MBBS ^10,¹¹, Shefali Jani, MD ^12,¹³, Shane George, MPH ^14,^15,¹⁶, Doris Tham, MBBS ^5,¹⁷, Michael Gordon, MD ¹⁸, Kate Klein, MadvNursPrac ², Catherine L. Wilson, MPH ², Chidambaram Prakash, MBBS ¹⁹, Natalie Phillips, Mphil ^9,¹⁶, Gaby Nieva, BNurs ⁷, Chris J. Selman, MBioStat ²⁰, Katherine J. Lee, PhD ^1,^20,²¹, Andrew Davidson, MD ^3,^20,^21,²², Jonathan C. Knott, PhD ³, Simon S. Craig, MPH ^2,^23,²⁴, Franz E. Babl, MD ^1,^2,^3,^5,²³
On behalf of the
PREDICT Research Network
¹ Department of Pediatrics, University of Melbourne, Melbourne, Victoria, Australia
² Emergency Research Group, Murdoch Children’s Research Institute, Melbourne, Victoria, Australia
³ Department of Critical Care, University of Melbourne, Melbourne, Victoria, Australia
⁴ Emergency Department, Grampians Health, Ballarat, Victoria, Australia
⁵ Emergency Department, Royal Children’s Hospital, Melbourne, Victoria, Australia
⁶ Emergency Department, Royal Melbourne Hospital, Melbourne, Victoria, Australia
⁷ Emergency Department, Women and Children’s Hospital, Adelaide, South Australia, Australia
⁸ Department of Acute Care Medicine, University of Adelaide, Adelaide, South Australia
⁹ Emergency Department, Queensland Children’s Hospital, Brisbane, Queensland, Australia
¹⁰ Emergency Department, Perth Children’s Hospital, Perth, Western Australia, Australia
¹¹ Division of Emergency Medicine and Pediatrics, School of Medicine, University of Western Australia, Crawley, Western Australia
¹² Emergency Department, The Children’s Hospital at Westmead, Sydney, New South Wales, Australia
¹³ Children’s Hospital at Westmead Clinical School, The University of Sydney, New South Wales, Australia
¹⁴ Departments of Emergency Medicine and Children’s Critical Care, Gold Coast University Hospital, Southport, Queensland, Australia
¹⁵ School of Medicine, Griffith University, Southport, Queensland, Australia
¹⁶ Child Health Research Centre, The University of Queensland, South Brisbane, Queensland, Australia
¹⁷ Emergency Department, Sunshine Hospital, Sunshine, Melbourne, Australia
¹⁸ Department of Psychiatry, Monash Medical Centre, Melbourne, Victoria, Australia
¹⁹ Department of Psychiatry, Royal Children’s Hospital, Melbourne, Victoria, Australia
²⁰ Clinical Epidemiology and Biostatistics, Murdoch Children’s Research Institute, Melbourne, Victoria, Australia
²¹ Melbourne Children’s Trials Centre, Murdoch Children’s Research Institute, Melbourne, Victoria, Australia
²² Department of Anaesthesia, Royal Children’s Hospital, Melbourne, Victoria, Australia
²³ Department of Pediatrics, Monash University, Melbourne, Victoria, Australia
²⁴ Emergency Department, Monash Medical Centre, Melbourne, Victoria, Australia

^∗Corresponding Author.

Sous presse. Épreuves corrigées par l'auteur. Disponible en ligne depuis le Saturday 15 February 2025

Abstract

Study objective

To determine whether oral olanzapine or oral diazepam was more effective at achieving behavioral containment for young people presenting to the emergency department with acute severe behavioral disturbance.

Methods

We conducted an open-label, multicenter, randomized controlled trial from October 22, 2021, to November 6, 2023. We enrolled young people aged between 9 and 17 years with acute severe behavioral disturbance deemed to require oral medication across 9 Australian emergency departments. We randomly assigned participants to a single weight-based oral dose of olanzapine or diazepam. The primary outcome was successful sedation (Sedation Assessment Tool score less than or equal to 0) without the need for additional sedatives one hour postrandomization. Secondary outcomes included adverse events; length of stay; aggression toward staff, participants, or parent/guardians; disposition; and satisfaction with care.

Results

We recruited 348 participants, with 176 assigned to olanzapine and 172 to diazepam. Successful sedation without the requirement for additional sedatives occurred in 103/168 (61%) in the olanzapine group and 90/158 (57%) in the diazepam group (adjusted risk difference 3.6%, 95% confidence interval –6.7% to 14.0%). No serious adverse events were reported in either group.

Conclusions

There was no evidence that oral olanzapine resulted in a greater proportion of participants with acute severe behavioral disturbance achieving successful sedation at one hour postrandomization than oral diazepam. Neither medication resulted in any serious adverse events; however, approximately 40% of participants in each group did not achieve successful sedation.

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Keywords : Pediatric agitation, Oral olanzapine, Oral diazepam

Plan

Introduction

Background

Importance

Goals of This Investigation

Methods

Study Design and Setting

Patient and Public Involvement

Selection of Participants

Randomization and Masking

Characteristics of the Study Subjects

Main Results

Limitations

Discussion

	Please see page XX for the Editor’s Capsule Summary of this article.
	Supervising editor: Steven M. Green, MD. Specific detailed information about possible conflict of interest for individual editors is available at editors.
	Author contributions: EMB, AK, DS, MLB, SJ, SG, KK, NP, KJL, AD, JCK, SC, and FEB conceived and designed the trial with input from CLW, GN, MG, and CP. CJS and KJL analyzed the data with input from EMB, KK, and FEB. EMB wrote the initial draft of the paper, with input from all authors. All authors have reviewed and approved the submitted version of the manuscript. FEB takes overall responsibility for the paper as a whole.
	Data sharing statement: The PEAChY-O trial data are held at the Murdoch Children’s Research Institute in Melbourne, Australia. Requests for data can be made at any time and can be initiated by email to franz.babl@rch.org.au. Requests will be considered within existing administrative, ethical and regulatory constraints and ongoing research by the study team.
	All authors attest to meeting the four ICMJE.org authorship criteria: (1) Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work; AND (2) Drafting the work or revising it critically for important intellectual content; AND (3) Final approval of the version to be published; AND (4) Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
	Funding and support: By Annals’ policy, all authors are required to disclose any and all commercial, financial, and other relationships in any way related to the subject of this article as per ICMJE conflict of interest guidelines (see www.icmje.org/). The study received funding from the Medical Research Futures Fund Million Minds Mission GNT1179137 (Canberra, Australia), the Emergency Medicine Foundation (Brisbane, Australia) and the Western Australian Child Research Fund (Perth, Australia). EMB reports grant funding from the National Health and Medical Research Council GNT2005279 (Canberra, Australia) and the University of Melbourne (Melbourne, Australia). FEB reports grant funding from the National Health and Medical Research Council (Canberra, Australia) and the Royal Children's Hospital Foundation (Melbourne, Australia). The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
	Trial registration number: ACTRN12621001236886