Department of Emergency Medicine, Loyola University Chicago, Stritch School of Medicine, Maywood, Illinois, USA.
Department of Medical Education, Loyola University Chicago, Stritch School of Medicine, Maywood, Illinois, USA.
Acad Emerg Med. 2021 Jun;28(6):647-654. doi: 10.1111/acem.14200. Epub 2021 Feb 16.
This study aimed to determine if 0.15 mg/kg intravenous (IV) subdissociative ketamine is noninferior to 0.3 mg/kg in emergency department (ED) patients with acute pain.
This randomized, prospective, double-blinded, noninferiority trial included patients' age 18 to 59 years presenting to the ED with acute moderate to severe pain. Subjects were randomized to IV subdissociative ketamine, 0.15 mg/kg ("low" dose) or 0.30 mg/kg ("high" dose), over 15 minutes. The primary endpoint was the 11-point numeric rating scale (NRS) pain score between groups at 30 minutes. Secondary endpoints included NRS pain scores at 15 and 60 minutes; change in NRS at 15, 30, and 60 minutes; rescue analgesia; and adverse effects. The noninferiority limit, δ , was set to 1.3.
Forty-nine patients were included in each group. After the differences in the baseline NRS score were adjusted for, the mean NRS score at 30 minutes was 4.7 (95% confidence interval [CI] = 3.8 to 5.5) in the low-dose group and 5.0 (95% CI = 4.2 to 5.8) in the high-dose group (mean difference = 0.4, 95% CI = -0.8 to 1.5), indicating that the low-dose subdissociative ketamine was noninferior to the high dose (lower limit of 95% CI = -0.8 to ≥1.3 = -δ ). Adverse effects were similar at 30 minutes. At 15 minutes, the high-dose group experienced greater change in NRS; however, more adverse effects occurred.
Our data did not detect a large difference in analgesia or adverse effect profile between 0.15 mg/kg IV ketamine and 0.30 mg/kg in the short-term treatment of acute pain in the ED.
本研究旨在确定在急诊科（ED）急性疼痛患者中，静脉（IV）亚分离性氯胺酮 0.15mg/kg 是否不如 0.3mg/kg。
这是一项随机、前瞻性、双盲、非劣效性试验，纳入年龄在 18 至 59 岁之间、因急性中重度疼痛而到 ED 就诊的患者。患者被随机分为 IV 亚分离性氯胺酮 0.15mg/kg（“低”剂量）或 0.30mg/kg（“高”剂量），输注时间为 15 分钟。主要终点是 30 分钟时两组之间的 11 点数字评定量表（NRS）疼痛评分。次要终点包括 15 分钟和 60 分钟时的 NRS 疼痛评分；15、30 和 60 分钟时的 NRS 变化；解救性镇痛；以及不良反应。非劣效性界限δ设定为 1.3。
每组纳入 49 例患者。在调整了基线 NRS 评分的差异后，低剂量组的 30 分钟平均 NRS 评分为 4.7（95%置信区间 [CI] = 3.8 至 5.5），高剂量组为 5.0（95% CI = 4.2 至 5.8）（平均差值 = 0.4，95% CI = -0.8 至 1.5），表明低剂量亚分离性氯胺酮与高剂量相比不劣效（95% CI 的下限为 -0.8 至≥1.3 = -δ）。30 分钟时不良反应相似。在 15 分钟时，高剂量组的 NRS 变化更大；然而，发生了更多的不良反应。
在 ED 中短期治疗急性疼痛时，我们的数据未发现 0.15mg/kg IV 氯胺酮与 0.30mg/kg 之间在镇痛或不良反应谱方面有显著差异。
