Hospital Universitario La Paz, Madrid, Spain; School of Medicine, Universidad Autónoma de Madrid, Hospital La Paz Institute for Health Research, and Spanish Clinical Research Network, Madrid, Spain.
Hospital Campo Grande, Valladolid, Spain.
Ann Emerg Med. 2020 Mar;75(3):315-328. doi: 10.1016/j.annemergmed.2019.07.028. Epub 2019 Oct 14.
The objective of the InMEDIATE study was to evaluate the change in intensity of traumatic pain over the first 20 min in adult patients treated with methoxyflurane versus standard analgesic treatment in Spain. This the first randomized, active-controlled, multicenter trial of methoxyflurane in the emergency setting in Europe.
This was a randomized, controlled study that enrolled adult patients with acute moderate to severe (score ≥4 on the 11-point Numeric Rating Scale) trauma-associated pain in 14 Spanish emergency departments. Patients were randomized 1:1 to methoxyflurane (up to 2×3 mL) or standard analgesic treatment. Coprimary endpoints were the change from baseline in Numeric Rating Scale pain intensity score during the first 20 minutes of treatment and time to first pain relief.
Three hundred five patients were randomized (methoxyflurane 156; standard analgesic treatment 149). Most patients in the standard analgesic treatment group (70%) received intravenous first-step analgesics and 9.4% of patients were treated with opioids. Mean decrease from baseline in Numeric Rating Scale pain intensity score was greater for methoxyflurane than standard analgesic treatment at all points, with a significant treatment difference overall up to 20 minutes (repeated-measures model 2.47 versus 1.39; treatment difference 1.00; 95% confidence interval 0.84 to 1.32). Median time to first pain relief was significantly shorter for methoxyflurane than standard analgesic treatment (3 versus 10 minutes). Methoxyflurane achieved better patient and clinician ratings for pain control and comfort of treatment than standard analgesic treatment and exceeded patient and clinician expectations of treatment in, respectively, 77% and 72% of cases compared with 38% and 19% for standard analgesic treatment.
These results support consideration of methoxyflurane as a nonnarcotic, easy-to-administer, rapid-acting, first-line alternative to currently available analgesic treatments for trauma pain.
InMEDIATE 研究的目的是评估在西班牙接受甲氧氟烷与标准镇痛治疗的成年患者创伤性疼痛强度在最初 20 分钟内的变化。这是欧洲首个在急救环境中进行的甲氧氟烷的随机、对照、多中心试验。
这是一项随机对照研究，纳入了 14 家西班牙急诊室中伴有急性中度至重度（11 点数字评分量表上≥4 分）创伤相关疼痛的成年患者。患者按 1:1 随机分为甲氧氟烷（最多 2×3 毫升）或标准镇痛治疗组。主要终点是治疗最初 20 分钟内数字评分量表疼痛强度评分的基线变化和首次疼痛缓解时间。
305 名患者被随机分组（甲氧氟烷 156 例；标准镇痛治疗 149 例）。标准镇痛治疗组大多数患者（70%）接受了静脉首步镇痛治疗，9.4%的患者接受了阿片类药物治疗。甲氧氟烷的数字评分量表疼痛强度评分从基线的平均下降幅度大于标准镇痛治疗组，在所有时间点均有显著的治疗差异，直至 20 分钟时（重复测量模型 2.47 比 1.39；治疗差异 1.00；95%置信区间 0.84 至 1.32）。甲氧氟烷首次疼痛缓解时间明显短于标准镇痛治疗组（3 分钟比 10 分钟）。甲氧氟烷在疼痛控制和治疗舒适度方面获得了优于标准镇痛治疗的患者和临床医生评分，在分别有 77%和 72%的病例中超过了患者和临床医生对治疗的期望，而标准镇痛治疗组仅有 38%和 19%的病例超过了患者和临床医生对治疗的期望。
这些结果支持将甲氧氟烷视为一种非阿片类药物、易于管理、起效迅速的一线替代目前可用的创伤性疼痛治疗方法。
