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雾化氯胺酮与静脉亚分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。

Comparison of Nebulized Ketamine to Intravenous Subdissociative Dose Ketamine for Treating Acute Painful Conditions in the Emergency Department: A Prospective, Randomized, Double-Blind, Double-Dummy Controlled Trial.

机构信息

Department of Emergency Medicine Maimonides Medical Center, Brooklyn, NY.

Department of Emergency Medicine Maimonides Medical Center, Brooklyn, NY.

出版信息

Ann Emerg Med. 2024 Oct;84(4):354-362. doi: 10.1016/j.annemergmed.2024.03.024. Epub 2024 May 2.

Abstract

STUDY OBJECTIVE

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.

METHODS

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.

RESULTS

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.

CONCLUSION

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.

摘要

研究目的

我们旨在评估和比较静脉亚分离剂量氯胺酮与雾化氯胺酮在急诊科(ED)急性疼痛患者中的镇痛效果和不良反应。

方法

我们对年龄在 18 岁及以上、数字评定量表疼痛评分≥5 的成年患者进行了一项前瞻性、随机、双盲、双模拟临床试验。我们将患者随机分为静脉注射(IV)组和雾化组,分别接受 0.3mg/kg 的氯胺酮或 0.75mg/kg 的雾化氯胺酮。主要结局是用药后 30 分钟时两组数字评定量表疼痛评分的差异。次要结局包括需要抢救性镇痛、每组不良反应的发生情况以及 15、30、60、90 和 120 分钟时疼痛评分的差异。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定为 1.3 分。

结果

我们共纳入了 150 名患者(每组 75 名)。两组基线时的平均疼痛评分均为 8.2,30 分钟时降至 3.6 和 3.8,平均差异为 0.23(95%CI-1.32 至 0.857)。我们没有观察到生命体征的临床相关变化。整个研究期间,两组均未发生严重不良事件。

结论

我们发现,在急诊科短期治疗中,静脉注射和雾化氯胺酮在治疗中重度急性疼痛方面没有差异,两种治疗方法均能在 30 分钟时显著降低疼痛评分。

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