TY - JOUR
T1 - Pharmacological emergency management of agitation in children and young people
T2 - protocol for a randomised controlled trial of oral medication (PEAChY-O)
AU - Bourke, Elyssia M.
AU - Borland, Meredith L.
AU - Kochar, Amit
AU - George, Shane
AU - Shellshear, Deborah
AU - Jani, Shefali
AU - Perkins, Kent
AU - Tham, Doris
AU - Gordon, Michael Solomon
AU - Klein, Kate
AU - Prakash, Chidambaram
AU - Lee, Katherine
AU - Davidson, Andrew
AU - Knott, Jonathan C.
AU - Craig, Simon
AU - Babl, Franz E.
AU - on behalf of the Paediatric Research in Emergency Departments International Collaborative (PREDICT)
N1 - Publisher Copyright:
© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
PY - 2023/2
Y1 - 2023/2
N2 - 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.
AB - 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.
KW - ACCIDENT & EMERGENCY MEDICINE
KW - Child & adolescent psychiatry
KW - Paediatric A&E and ambulatory care
UR - http://www.scopus.com/inward/record.url?scp=85151316478&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2022-067433
DO - 10.1136/bmjopen-2022-067433
M3 - Article
C2 - 36997250
AN - SCOPUS:85151316478
SN - 2044-6055
VL - 13
JO - BMJ Open
JF - BMJ Open
IS - 3
M1 - e067433
ER -