Evidence map›Paper›PMID 36997250›Full record

ArticleBMJ open2023

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 and 7 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
1.3field-weighted citation impact, top 22% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 6 citations in OpenAlex.

  1. Trial
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors at 12 institutions in 1 country.

Elyssia M BourkeEmergency Research, Murdoch Children's Research Institute, Parkville, Victoria, Australia elyssia.bourke@mcri.edu.au.ORCID 0000-0001-5617-0955
Meredith L BorlandEmergency Department, Perth Children's Hospital, Nedlands, Western Australia, Australia.ORCID 0000-0002-5326-5008
Amit KocharEmergency Department, Women and Children's Hospital Adelaide, Adelaide, South Australia, Australia.
Shane GeorgeChildren's Critical Care Service, Gold Coast University Hospital, Southport, Queensland, Australia.ORCID 0000-0002-8880-1245
Deborah ShellshearEmergency Department, Queensland Children's Hospital, South Brisbane, Queensland, Australia.
Shefali JaniEmergency Department, Children's Hospital at Westmead, Westmead, New South Wales, Australia.
Kent PerkinsEmergency Department, Sunshine Coast University Hospital, Sunshine Coast, Queensland, Australia.
Doris ThamPaediatric Emergency Department, Western Health, Footscray, Victoria, Australia.
Michael Solomon GordonPsychological Medicine, Monash Health, Clayton, Victoria, Australia.
Kate KleinEmergency Research, Murdoch Children's Research Institute, Parkville, Victoria, Australia.
Chidambaram PrakashDepartment of Psychiatry, The Royal Children's Hospital Melbourne, Parkville, Victoria, Australia.
Katherine LeeDepartment of Paediatrics, University of Melbourne, Parkville, Victoria, Australia.
Andrew DavidsonDepartment of Critical Care, University of Melbourne, Parkville, Victoria, Australia.
Jonathan C KnottDepartment of Critical Care, University of Melbourne, Parkville, Victoria, Australia.
Simon CraigDepartment of Paediatrics, Monash University, Clayton, Victoria, Australia.ORCID 0000-0003-2594-1643
Franz E BablEmergency Research, Murdoch Children's Research Institute, Parkville, Victoria, Australia.ORCID 0000-0002-1107-2187
Paediatric research in Emergency Departments International Collaborative (PREDICT)
Royal Children's Hospital · AUThe University of Melbourne · AUChildren's Health Queensland Hospital and Health Service · AUFootscray Hospital · AUGriffith University · AUMonash Health · AUMonash Medical Centre · AUPrincess Margaret Hospital for Children · AUSunshine Coast University Hospital · AUThe Royal Melbourne Hospital · AUThe University of Sydney · AUWomen's and Children's Hospital · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionAcute 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.

Indexed as

Prunus persicaAdolescentAdultChildEquivalence Trials as TopicHumansInfant, NewbornMulticenter Studies as TopicOlanzapineRandomized Controlled Trials as TopicOlanzapineACCIDENT & EMERGENCY MEDICINEChild & adolescent psychiatryPaediatric A&E and ambulatory care

Identifiers

PMID36997250
PMCPMC10069548
OpenAlexW4361272018

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.