Department of Emergency Medicine, Morgagni-Pierantoni Hospital, Forlì, Italy.
Department of Emergency Medicine, Vittorio Emanuele University Hospital, Catania, Italy.
Adv Ther. 2019 Jan;36(1):244-256. doi: 10.1007/s12325-018-0830-x. Epub 2018 Nov 22.
Low-dose methoxyflurane, administered via a hand-held inhaler, has been used for short-term pain relief in emergency medicine in Australia and New Zealand for over 40 years, and was recently approved in Europe for the rapid relief of moderate-to-severe trauma-related pain in adults. There is currently a lack of data for methoxyflurane versus active comparators, therefore this trial will investigate the efficacy and safety of inhaled methoxyflurane compared with standard of care (SoC) in the treatment of acute trauma-related pain in pre-hospital and ED settings in Italy.
MEDITA (Methoxyflurane in Emergency Department in ITAly) is a Phase IIIb, prospective, randomised, active-controlled, parallel-group, open-label, multicentre trial. A total of 272 adult patients with moderate-to-severe pain [score ≥ 4 on the Numerical Rating Scale (NRS)] due to limb trauma will be randomised 1:1 to receive 3 mL methoxyflurane (self-administered by the patient via inhalation under supervision of a trained person) or medications that currently comprise the SoC in Italy [intravenous (IV) morphine for severe pain (NRS ≥ 7); IV paracetamol or ketoprofen for moderate pain (NRS 4-6)], administered as soon as possible after randomisation.
Pain intensity will be measured using a 100-mm visual analogue scale (VAS) at baseline (time of randomisation) and at intervals up to 30 min. Time of onset of pain relief as reported by the patient and use of rescue medication will be recorded. The patient will rate the efficacy and the healthcare professional will rate the practicality of study treatment at 30 min after randomisation using a 5-point Likert scale. Adverse events will be recorded until safety follow-up at 14 ± 2 days. Vital signs will be measured at baseline, 10 and 30 min. The primary aim is to demonstrate non-inferiority of methoxyflurane versus SoC for the change in VAS pain intensity from baseline (randomisation) to 3, 5 and 10 min.
EudraCT number: 2017-001565-25. Clinicaltrials.gov identifier: NCT03585374.
Mundipharma Pharmaceuticals srl.
在澳大利亚和新西兰，低剂量甲氧氟烷通过手动吸入器给药已用于急诊医学中的短期止痛已有 40 多年，最近在欧洲被批准用于成人快速缓解中度至重度创伤相关疼痛。目前缺乏甲氧氟烷与活性对照物的比较数据，因此这项试验将研究吸入甲氧氟烷与意大利院前和急诊环境中标准治疗（SoC）相比治疗急性创伤相关疼痛的疗效和安全性。
MEDITA（甲氧氟烷在意大利急诊室）是一项 IIIb 期、前瞻性、随机、活性对照、平行组、开放标签、多中心试验。共有 272 名因肢体创伤而出现中度至重度疼痛（NRS 评分≥4）的成年患者将随机分为 1:1 组，分别接受 3 mL 甲氧氟烷（由患者自行通过吸入在受过培训的人员监督下给药）或目前在意大利构成 SoC 的药物[静脉注射（IV）吗啡用于重度疼痛（NRS≥7）；IV 对乙酰氨基酚或酮洛芬用于中度疼痛（NRS 4-6）]，在随机分组后尽快给药。
疼痛强度将使用基线（随机分组时）和 30 分钟内的 100-mm 视觉模拟量表（VAS）进行测量。记录患者报告的疼痛缓解开始时间和使用解救药物的情况。患者将在随机分组后 30 分钟时使用 5 分制 Likert 量表对研究治疗的疗效和医疗保健专业人员的实用性进行评分。记录不良事件，直至 14±2 天的安全性随访。生命体征将在基线、10 和 30 分钟时测量。主要目的是证明甲氧氟烷与 SoC 相比，在基线（随机分组）至 3、5 和 10 分钟时 VAS 疼痛强度的变化无劣效性。
EudraCT 编号：2017-001565-25。Clinicaltrials.gov 标识符：NCT03585374。
Mundipharma 制药有限公司。
