Emergency Research, Murdoch Children's Research Institute, Parkville, Victoria, Australia
Department of Paediatrics, University of Melbourne, Parkville, Victoria, Australia.
BMJ Open. 2023 Mar 30;13(3):e067436. doi: 10.1136/bmjopen-2022-067436.
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 intramuscular olanzapine is more effective than intramuscular droperidol at successfully sedating young people with ASBD requiring intramuscular sedation.
This study is a multicentre, open-label, superiority randomised controlled trial. Young people aged between 9 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 intramuscular olanzapine and intramuscular droperidol. 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 approval was received from the Royal Children's Hospital Human Research Ethics Committee (HREC/69948/RCHM-2021). This incorporated a waiver of informed consent for the study. The findings will be disseminated in a peer-reviewed journal and at academic conferences.
ACTRN12621001238864.
急性严重行为障碍（ASBD）是成人和年轻人在急诊科（ED）中越来越频繁出现的一种病症。尽管就诊人数不断增加，且患者、家属和护理人员面临着重大风险，但针对儿童和青少年最有效的药物治疗管理，仍缺乏相关证据。本研究旨在确定肌肉注射奥氮平与肌肉注射氟哌啶醇相比，在成功镇静需要肌肉注射镇静的 ASBD 青少年方面是否更有效。
这是一项多中心、开放性、优效性随机对照试验。年龄在 9 至 17 岁和 364 天之间，因 ASBD 就诊 ED 且被认为需要药物进行行为控制的年轻人将被纳入研究。参与者将以 1:1 的比例随机分配至单剂基于体重的肌肉注射奥氮平或肌肉注射氟哌啶醇。主要结局是在随机分组后 1 小时达到无需额外镇静的成功镇静的参与者比例。次要结局将包括评估不良事件、ED 中提供的其他药物、ASBD 进一步发作、ED 和住院时间以及管理满意度。使用意向治疗分析确定有效性，将药物疗效作为次要结局的一部分，通过方案分析确定。主要结局是 1 小时内成功镇静的比例，在每个治疗组内以百分比表示，比较结果以风险差异及其 95%CI 表示。
皇家儿童医院人类研究伦理委员会（HREC/69948/RCHM-2021）已批准该研究。这包含了对该研究的知情同意豁免。研究结果将在同行评议的期刊和学术会议上发表。
ACTRN12621001238864。
