Prehosp Emerg Care. 2021 Jul-Aug;25(4):519-529. doi: 10.1080/10903127.2020.1808746. Epub 2020 Oct 15.
: Acute pain management is fundamental in prehospital trauma care. Early pain control may decrease the risk of developing post-traumatic stress disorder (PTSD) and chronic pain. Fentanyl and ketamine are frequently used off-label, but there is a paucity of comparative data to guide decision-making about treatment of prehospital severe, acute pain. This trial will determine whether the addition of single dose of intranasal ketamine to fentanyl is more effective for the treatment of acute traumatic pain than administration of fentanyl alone.: This two-part study consists of prehospital and 90-day follow-up components (NCT02866071). The prehospital trial is a blinded, randomized, controlled trial of adult men (age 18-65 years) rating pain ≥7/10 after an acute traumatic injury of any type. Women will be excluded due to inability to confirm pregnancy status and unknown fetal risk. Paramedics will screen patients receiving standard of care fentanyl and, after obtaining standard informed consent, administer 50 mg intranasal ketamine or matching volume saline as placebo. Upon emergency department (ED) arrival, research associates will serially assess pain, concomitant treatments, and adverse side effects. Enrolled subjects will be approached for consent to participate in the 90-day follow-up study to determine rates of PTSD and chronic pain development. The primary outcome of the prehospital study is reduction in pain on the Verbal Numerical Rating Scale between baseline and 30-minutes after study drug administration. The proportion achieving a reduction of ≥2-points will be compared between study arms using a Chi-square test. Secondary outcomes of the prehospital trial include reduction in reported pain at the time of ED arrival and at 30 minutes intervals for up to three hours of ED care, the incidence of adverse events, and additional opiate requirements prior to ED arrival and within the first three hours of ED care. The outcomes in the follow-up study are satisfaction with life and development of PTSD or chronic pain at 90 days after injury. An intention-to-treat approach will be used.: These studies will test the hypotheses that ketamine plus fentanyl, when compared to fentanyl alone, effectively manages pain, decreases opiate requirements, and decreases PTSD at 90 days.
: 急性疼痛管理是院前创伤护理的基础。早期疼痛控制可能会降低发生创伤后应激障碍（PTSD）和慢性疼痛的风险。芬太尼和氯胺酮经常被超适应证使用，但缺乏比较数据来指导院前严重急性疼痛治疗的决策。本试验旨在确定与单独使用芬太尼相比，单次鼻腔内给予氯胺酮是否能更有效地治疗急性创伤性疼痛。: 这项两部分研究包括院前和 90 天随访部分（NCT02866071）。院前试验是一项盲法、随机、对照试验，纳入年龄在 18-65 岁之间的成年男性（年龄 18-65 岁），在遭受任何类型的急性创伤性损伤后疼痛评分为 7/10 或以上。由于无法确认妊娠状态和未知的胎儿风险，女性将被排除在外。护理人员将对接受标准护理芬太尼的患者进行筛查，在获得标准知情同意后，给予 50mg 鼻腔内氯胺酮或匹配容量的生理盐水作为安慰剂。到达急诊部（ED）后，研究助理将连续评估疼痛、伴随治疗和不良反应。入组患者将被邀请参加 90 天随访研究，以确定 PTSD 和慢性疼痛发展的发生率。院前研究的主要结局是在研究药物给药后 30 分钟内，疼痛的数字评分量表（Verbal Numerical Rating Scale）评分较基线的降低程度。使用卡方检验比较研究组之间达到≥2 分降低的比例。院前试验的次要结局包括 ED 到达时和 ED 护理 30 分钟间隔至 3 小时的报告疼痛的降低程度，不良事件的发生率，以及 ED 到达前和 ED 护理前 3 小时内的额外阿片类药物需求。随访研究的结局是伤后 90 天的生活满意度和 PTSD 或慢性疼痛的发展。将采用意向治疗方法。: 这些研究将检验以下假设：与单独使用芬太尼相比，氯胺酮加芬太尼能更有效地管理疼痛，减少阿片类药物的需求，并在 90 天内降低 PTSD。
