Shimonovich Shachar, Gigi Roy, Shapira Amir, Sarig-Meth Tal, Nadav Danielle, Rozenek Mattan, West Debra, Halpern Pinchas
Sackler School of Medicine at Tel Aviv University, 55 Haim Levanon Street, Ramat Aviv, 69978, Israel.
Department of Orthopedic Surgery, Tel Aviv Sourasky Medical Center, 6 Weizmann Street, Tel Aviv, 64239, Israel.
BMC Emerg Med. 2016 Nov 9;16(1):43. doi: 10.1186/s12873-016-0107-0.
Ketamine has been well studied for its efficacy as an analgesic agent. However, intranasal (IN) administration of ketamine has only recently been studied in the emergency setting. The objective of this study was to elucidate the efficacy and adverse effects of a sub-dissociative dose of IN Ketamine compared to IV and IM morphine.
A single-center, randomized, prospective, parallel clinical trial of efficacy and safety of IN ketamine compared to IV and IM morphine for analgesia in the emergency department (ED). A convenience sample of 90 patients aged 18-70 experiencing moderate-severe acute traumatic pain (≥80 mm on 100 mm Visual Analog Scale [VAS]) were randomized to receive either 1.0 mg/kg IN ketamine, 0.1 mg/kg IV MO or 0.15 mg/kg IM MO. Pain relief and adverse effects were recorded for 1 h post-administration. The primary outcome was efficacy of IN ketamine compared to IV and IM MO, measured by "time-to-onset" (defined as a ≥15 mm pain decrease on VAS), as well as time to and degree of maximal pain reduction.
The 3 study groups showed a highly significant, similar maximal pain reduction of 56 ± 26 mm for IN Ketamine, and 59 ± 22 and 48 ± 30 for IV MO and IM MO, respectively. IN Ketamine provided clinically-comparable results to those of IV MO with regards to time to onset (14.3 ± 11.2 v. 8.9 ± 5.6 min, respectively) as well as in time to maximal pain reduction (40.4 ± 16.3) versus (33.4 ± 18), respectively.
IN ketamine shows efficacy and safety comparable to IV and IM MO. Given the benefits of this mode of analgesia in emergencies, it should be further studied for potential clinical applications.
Retrospectively registered on 27 June 2016. ClinicalTrials.gov ID: NCT02817477.
氯胺酮作为一种镇痛剂的疗效已得到充分研究。然而，氯胺酮的鼻内（IN）给药方式直到最近才在急诊环境中得到研究。本研究的目的是阐明与静脉注射（IV）和肌肉注射（IM）吗啡相比，亚解离剂量的鼻内氯胺酮的疗效和不良反应。
一项单中心、随机、前瞻性、平行临床试验，比较鼻内氯胺酮与静脉注射和肌肉注射吗啡在急诊科（ED）镇痛的疗效和安全性。选取90例年龄在18 - 70岁、经历中度至重度急性创伤性疼痛（100毫米视觉模拟量表[VAS]上≥80毫米）的患者作为便利样本，随机分为接受1.0毫克/千克鼻内氯胺酮、0.1毫克/千克静脉注射吗啡或0.15毫克/千克肌肉注射吗啡。给药后1小时记录疼痛缓解情况和不良反应。主要结局是鼻内氯胺酮与静脉注射和肌肉注射吗啡相比的疗效，通过“起效时间”（定义为VAS上疼痛降低≥15毫米）以及最大疼痛缓解时间和程度来衡量。
3个研究组显示出高度显著且相似的最大疼痛缓解程度，鼻内氯胺酮为56±26毫米，静脉注射吗啡为59±22毫米，肌肉注射吗啡为48±30毫米。在起效时间（分别为14.3±11.2分钟和8.9±5.6分钟）以及最大疼痛缓解时间（分别为40.4±16.3分钟和33.4±18分钟）方面，鼻内氯胺酮与静脉注射吗啡的临床结果相当。
鼻内氯胺酮显示出与静脉注射和肌肉注射吗啡相当的疗效和安全性。鉴于这种镇痛方式在急诊中的益处，应进一步研究其潜在的临床应用。
于2016年6月27日进行回顾性注册。ClinicalTrials.gov标识符：NCT02817477。
