Study objective

We hypothesized that the use of intramuscular ketamine would result in a clinically relevant shorter time to target sedation.

Methods

We conducted a randomized clinical trial comparing the rapidity of onset, level of sedation, and adverse effect profile of ketamine compared to a combination of midazolam and haloperidol for behavioral control of emergency department patients with severe psychomotor agitation. We included patients with severe psychomotor agitation measured by a Richmond Agitation Score (RASS) ≥+3. Patients in the ketamine group were treated with a 5 mg/kg intramuscular injection. Patients in the midazolam and haloperidol group were treated with a single intramuscular injection of 5 mg midazolam and 5 mg haloperidol. The primary outcome was the time, in minutes, from study medication administration to adequate sedation, defined as RASS ≤-1. Secondary outcomes included the need for rescue medications and serious adverse events.

Results

Between June 30, 2018, and March 13, 2020, we screened 308 patients and enrolled 80. The median time to sedation was 14.7 minutes for midazolam and haloperidol versus 5.8 minutes for ketamine (difference 8.8 minutes [95% confidence interval (CI) 3.0 to 14.5]). Adjusted Cox proportional model analysis favored the ketamine arm (hazard ratio 2.43, 95% CI 1.43 to 4.12). Five (12.5%) patients in the ketamine arm and 2 (5.0%) patients in the midazolam and haloperidol arm experienced serious adverse events (difference 7.5% [95% CI -4.8% to 19.8%]).

Conclusion

In ED patients with severe agitation, intramuscular ketamine provided significantly shorter time to adequate sedation than a combination of intramuscular midazolam and haloperidol.

中文翻译：

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在急诊科使用氯胺酮进行快速搅拌控制：一项盲法、随机对照试验

学习目标

我们假设肌肉注射氯胺酮会导致临床相关的更短的靶向镇静时间。

方法

我们进行了一项随机临床试验，比较了氯胺酮与咪达唑仑和氟哌啶醇的组合在严重精神运动性激越急诊科患者行为控制方面的起效速度、镇静水平和不良反应特征。我们纳入了通过里士满激越评分 (RASS) ≥+3 测量的严重精神运动激越患者。氯胺酮组患者接受 5 mg/kg 肌肉注射治疗。咪达唑仑和氟哌啶醇组患者接受单次肌肉注射咪达唑仑和氟哌啶醇 5 mg 的治疗。主要结果是从研究药物给药到充分镇静的时间，以分钟为单位，定义为 RASS ≤-1。次要结局包括对抢救药物的需求和严重的不良事件。

结果

在 2018 年 6 月 30 日至 2020 年 3 月 13 日期间，我们筛选了 308 名患者并招募了 80 名患者。咪达唑仑和氟哌啶醇的中位镇静时间为 14.7 分钟，而氯胺酮为 5.8 分钟（差异 8.8 分钟 [95% 置信区间 (CI) 3.0至 14.5]）。调整后的 Cox 比例模型分析有利于氯胺酮组（风险比 2.43，95% CI 1.43 至 4.12）。氯胺酮组 5 名 (12.5%) 患者和咪达唑仑和氟哌啶醇组 2 名 (5.0%) 患者出现严重不良事件（差异 7.5% [95% CI -4.8% 至 19.8%]）。

结论

在患有严重躁动的 ED 患者中，肌注氯胺酮提供的充分镇静时间明显短于肌注咪达唑仑和氟哌啶醇的组合。