We aimed to assess and compare the analgesic efficacy and adverse effects of intravenous subdissociative-dose ketamine to nebulized ketamine in emergency department (ED) patients with acute painful conditions. We conducted a prospective, randomized, double-blind, double-dummy clinical trial in adult patients (ages 18 and older) with a numerical rating scale pain score of ≥5. We randomized subjects to receive either a single dose of 0.3 mg/kg of intravenous (IV) ketamine or 0.75 mg/kg of nebulized ketamine through a breath-actuated nebulizer. Primary outcome was the difference in pain scores on the numerical rating scale between groups at 30 minutes postmedication administration. The secondary outcomes included the need for rescue analgesia, occurrences of adverse events in each group, and the difference in pain scores at 15, 30, 60, 90, and 120 minutes. We calculated a 95% confidence interval (CI) for a mean difference at 30 minutes, with a minimum clinically important difference set at 1.3 points. We enrolled 150 subjects (75 per group). Mean pain scores through numerical rating scale were 8.2 for both groups at baseline, which decreased to 3.6 and 3.8 at 30 minutes, yielding a mean difference of 0.23 (95% CI −1.32 to 0.857). We observed no clinically concerning changes in vital signs. No serious adverse events occurred in any of the groups throughout the study period. We found no difference between the administration of IV and nebulized ketamine for the short-term treatment of moderate to severe acute pain in the ED, with both treatments providing a clinically meaningful reduction in pain scores at 30 minutes.

中文翻译：

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雾化氯胺酮与静脉内亚解离剂量氯胺酮治疗急诊科急性疼痛的比较：一项前瞻性、随机、双盲、双模拟对照试验


我们旨在评估和比较静脉注射亚解离剂量氯胺酮与雾化氯胺酮对急诊科 （ED） 急性疼痛患者的镇痛效果和不良反应。我们在成年患者 （18 岁及以上） 中进行了一项前瞻性、随机、双盲、双模拟临床试验，数字评定量表疼痛评分为 ≥5。我们随机分配受试者通过呼吸驱动雾化器接受单剂量 0.3 mg/kg 静脉注射 （IV） 氯胺酮或 0.75 mg/kg 雾化氯胺酮。主要结果是给药后 30 分钟两组数字评定量表上疼痛评分的差异。次要结局包括抢救镇痛的需要、每组不良事件的发生率以及 15 、 30 、 60 、 90 和 120 分钟疼痛评分的差异。我们计算了 30 分钟时平均差异的 95% 置信区间 （CI），最小临床重要差异设置为 1.3 分。我们招募了 150 名受试者（每组 75 名）。基线时，两组通过数字评定量表的平均疼痛评分为 8.2，在 30 分钟时降至 3.6 和 3.8，平均差异为 0.23 （95% CI -1.32 至 0.857）。我们没有观察到临床上令人担忧的生命体征变化。在整个研究期间，任何组均未发生严重不良事件。我们发现静脉注射和雾化氯胺酮给药在急诊科中度至重度急性疼痛的短期治疗中没有差异，两种治疗在 30 分钟时均提供具有临床意义的疼痛评分降低。