DREEAM: Department of Research and Education in Emergency Medicine, Acute Medicine and Major Trauma, Nottingham University Hospitals NHS Trust, Nottingham, UK.
Emergency Department, Royal Victoria Infirmary, Newcastle Upon Tyne, UK.
Emerg Med J. 2014 Aug;31(8):613-8. doi: 10.1136/emermed-2013-202909. Epub 2014 Apr 17.
To evaluate the short-term efficacy and safety of methoxyflurane for the treatment of acute pain in patients presenting to an emergency department (ED) with minor trauma.
STOP! was a randomised, double-blind, multicentre, placebo-controlled study conducted at six sites in the UK. A total of 300 patients, 90 of whom were adolescent patients (age 12-17 years), were randomised 150:150 to receive either methoxyflurane via a Penthrox inhaler or placebo. The primary end point of the study was the change in pain intensity as measured using the visual analogue scale (VAS) from baseline to 5, 10, 15 and 20 min after the start of study drug inhalation. Patients were supplied with one inhaler containing 3 mL methoxyflurane or 5 mL placebo after enrolment and initial assessments. Age group (adolescent/adult) and baseline VAS score were controlled for in the statistical analyses.
A total of 149 patients received methoxyflurane, and 149 patients received placebo. Demographic and baseline characteristics were comparable between the groups. Methoxyflurane reduced pain severity significantly more than placebo (p<0.0001) at all time points tested, with the greatest estimated treatment effect of -18.5 mm (adjusted change from baseline) seen at 15 min after the start of treatment. Methoxyflurane was well tolerated, with the majority of adverse reactions being mild, transient and in line with anticipated pharmacological action.
The results of this study suggest that methoxyflurane administered via the Penthrox inhaler is an efficacious, safe, and rapidly acting analgesic.
NCT01420159.
评估甲氧氟烷治疗因轻微创伤就诊急诊科（ED）的急性疼痛患者的短期疗效和安全性。
STOP！是一项在英国六个地点进行的随机、双盲、多中心、安慰剂对照研究。共纳入 300 例患者，其中 90 例为青少年（12-17 岁）患者，随机分为 150:150 接受 Penthrōx 吸入器给予甲氧氟烷或安慰剂。该研究的主要终点为从基线开始至吸入研究药物后 5、10、15 和 20 分钟时，使用视觉模拟量表（VAS）评估疼痛强度的变化。纳入和初始评估后，患者接受一个装有 3 毫升甲氧氟烷或 5 毫升安慰剂的吸入器。在统计分析中，控制了年龄组（青少年/成人）和基线 VAS 评分。
共有 149 例患者接受甲氧氟烷，149 例患者接受安慰剂。两组的人口统计学和基线特征无差异。甲氧氟烷与安慰剂相比，能更显著减轻疼痛严重程度（p<0.0001），治疗后 15 分钟时，估计的最大治疗效果为 -18.5mm（与基线相比的调整变化）。甲氧氟烷耐受性良好，大多数不良反应为轻度、短暂，与预期的药理学作用一致。
这项研究的结果表明，Penthrōx 吸入器给予的甲氧氟烷是一种有效、安全且起效迅速的镇痛药。
NCT01420159。
