静脉注射亚解离剂量氯胺酮用于院前镇痛是否不劣于吗啡（KETAMORPH研究）：一项随机对照试验的研究方案
Is intravenously administered, subdissociative-dose KETAmine non-inferior to MORPHine for prehospital analgesia (the KETAMORPH study): study protocol for a randomized controlled trial.
作者信息
Le Cornec Clément, Lariby Said, Brenckmann Vivien, Hardouin Jean Benoit, Ecoffey Claude, Le Pottier Marion, Fradin Philippe, Broch Hélène, Kabbaj Amine, Auffret Yannick, Deciron Florence, Longo Céline, Javaudin François, Le Bastard Quentin, Jenvrin Joël, Montassier Emmanuel
机构信息
Emergency Department, Nantes University Hospital, 44000, Nantes, France.
Tours University Hospital, Emergency Medicine Department, Tours, France.
出版信息
Trials. 2018 May 2;19(1):260. doi: 10.1186/s13063-018-2634-3.
BACKGROUND
Acute pain is a common condition among prehospital patients and prompt management is pivotal. Opioids are the most frequently analgesics used in the prehospital setting. However, opioids are highly addictive, and some patients may develop opioid dependence, even when they are exposed to brief opioid treatments. Therefore, alternative non-opioid analgesia should be developed to manage pain in the prehospital setting. Used at subdissociative doses, ketamine, a noncompetitive N-methyl-D-aspartate and glutamate receptor antagonist, provides analgesic effects accompanied by preservation of protective airway reflexes. In this context, we will carry out a randomized controlled, open-label, multicenter trial to compare a subdissociative dose of ketamine to morphine to provide pain relief in the prehospital setting, in patients with traumatic and non-traumatic pain.
METHODS/DESIGN: This will be a multicenter, single-blind, randomized controlled trial. Consecutive adults will be enrolled in the prehospital setting if they experience moderate to severe, acute, non-traumatic and traumatic pain, defined as a numeric rating scale score greater or equal to 5. Patients will be randomized to receive ketamine or morphine by intravenous push. The primary outcome will be the between-group difference in mean change in numeric rating scale pain scores measured from the time before administration of the study medication to 30 min later.
DISCUSSION
This upcoming randomized clinical trial was design to assess the efficacy and safety of ketamine, an alternative non-opiate analgesia, to manage non-traumatic and traumatic pain in the prehospital setting. We aim to provide evidence to change prescribing practices to reduce exposition to opioids and the subsequent risk of addiction.
TRIAL REGISTRATION
ClinicalTrials.gov, ID: NCT03236805 . Registered on 2 August 2017.
背景
急性疼痛是院前患者的常见病症，及时处理至关重要。阿片类药物是院前环境中最常用的镇痛药。然而，阿片类药物极易成瘾，即使是接受短暂的阿片类药物治疗，一些患者也可能产生阿片类药物依赖。因此，应开发替代性非阿片类镇痛方法来处理院前环境中的疼痛。氯胺酮作为一种非竞争性N-甲基-D-天冬氨酸和谷氨酸受体拮抗剂，在亚解离剂量使用时可提供镇痛效果，同时保留保护性气道反射。在此背景下，我们将开展一项随机对照、开放标签、多中心试验，比较亚解离剂量的氯胺酮与吗啡在院前环境中对创伤性和非创伤性疼痛患者的止痛效果。
方法/设计：这将是一项多中心、单盲、随机对照试验。连续纳入的成年患者若经历中度至重度急性非创伤性和创伤性疼痛（定义为数字评分量表得分大于或等于5），则纳入院前研究。患者将被随机分组，通过静脉推注接受氯胺酮或吗啡治疗。主要结局将是从研究药物给药前至给药后30分钟期间数字评分量表疼痛评分的平均变化的组间差异。
讨论
这项即将开展的随机临床试验旨在评估氯胺酮（一种替代性非阿片类镇痛药）在院前环境中处理非创伤性和创伤性疼痛的疗效和安全性。我们旨在提供证据以改变处方习惯，减少阿片类药物暴露及后续成瘾风险。
试验注册
ClinicalTrials.gov，标识符：NCT03236805。于2017年8月2日注册。
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