Barbic David, Andolfatto Gary, Grunau Brian, Scheuermeyer Frank X, MacEwan William, Honer William G, Wong Hubert, Barbic Skye P
Department of Emergency Medicine, St Paul's Hospital, 1081 Burrard St, Vancouver, BC, V6Z 1Y6, Canada.
Centre for Health Evaluation Outcome Sciences, Vancouver, BC, Canada.
Trials. 2018 Nov 26;19(1):651. doi: 10.1186/s13063-018-2992-x.
The rapid control of patients presenting to the emergency department (ED) with psychomotor agitation and violent behavior is paramount for the safety of patients and ED staff. The use of intramuscular (IM) ketamine in the pre-hospital and ED settings has demonstrated promising preliminary results to provide rapid and safe behavioral control. A prospective, randomized controlled trial is required to measure the potential superiority of IM ketamine compared to current standard care (IM benzodiazepines plus antipsychotics).
This will be a parallel, prospective, randomized, controlled trial of 5 mg/kg IM ketamine compared to a combination of 5 mg IM midazolam and 5 mg IM haloperidol. The study will enroll approximately 184 patients, randomized equally to two study arms. There will be one study visit during which study medication will be administered and assessments will be completed. A follow-up safety visit will occur on day 3. The primary objective of this study is to compare IM ketamine to a combination of IM midazolam and haloperidol with regards to the time required for adequate behavioral control, in minutes, in patients presenting to the ED with psychomotor agitation and violent behavior, as measured by the Richmond Agitation-Sedation Scale (RASS).
We present a novel study to determine whether ketamine is a rapid and safe option, compared to a combination of midazolam and haloperidol for the sedation of patients presenting to the ED with psychomotor agitation and violent behavior. To our knowledge, this study is the first randomized controlled trial to compare ketamine to current standard care for this indication. We have attempted to address numerous logistical issues with the design of this study including a waiver of consent, ensuring adequate blinding of outcome assessors, patient enrolment, and data monitoring.
Clinicaltrials.gov, NCT03375671 . Registered on 18 December 2017.
对于急诊科（ED）中出现精神运动性激越和暴力行为的患者，迅速实施控制对患者及急诊科工作人员的安全至关重要。在院前和急诊科环境中使用肌肉注射（IM）氯胺酮已显示出有希望的初步结果，可实现快速且安全的行为控制。需要进行一项前瞻性随机对照试验，以衡量IM氯胺酮相对于当前标准治疗（IM苯二氮䓬类药物加抗精神病药物）的潜在优势。
这将是一项平行、前瞻性、随机对照试验，比较5mg/kg IM氯胺酮与5mg IM咪达唑仑和5mg IM氟哌啶醇的组合。该研究将招募约184名患者，随机平均分为两个研究组。将有一次研究访视，在此期间给予研究药物并完成评估。在第3天进行随访安全访视。本研究的主要目的是比较IM氯胺酮与IM咪达唑仑和氟哌啶醇组合，对于急诊科中出现精神运动性激越和暴力行为的患者，以里士满躁动镇静量表（RASS）衡量，达到充分行为控制所需的时间（以分钟为单位）。
我们开展了一项新研究，以确定与咪达唑仑和氟哌啶醇的组合相比，氯胺酮对于急诊科中出现精神运动性激越和暴力行为的患者进行镇静是否是一种快速且安全的选择。据我们所知，本研究是第一项针对该适应症将氯胺酮与当前标准治疗进行比较的随机对照试验。我们已尝试在本研究设计中解决众多后勤问题，包括豁免知情同意、确保结果评估者充分盲法、患者招募和数据监测。
Clinicaltrials.gov，NCT03375671。于2017年12月18日注册。
