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吸入甲氧氟烷治疗因创伤导致疼痛而收入医院急诊科的患者:一项随机、双盲、安慰剂对照试验(PenASAP 研究)。

Inhaled methoxyflurane for the management of trauma related pain in patients admitted to hospital emergency departments: a randomised, double-blind placebo-controlled trial (PenASAP study).

机构信息

Emergency Department SAMU-SMUR 95, CHG Pontoise-Beaumont/Oise Pontoise.

Emergency Department, CHU Purpan, Toulouse.

出版信息

Eur J Emerg Med. 2020 Dec;27(6):414-421. doi: 10.1097/MEJ.0000000000000686.

DOI:10.1097/MEJ.0000000000000686
PMID:32282467
Abstract

BACKGROUND

Oligo-analgesia is common in the emergency department (ED). This study aimed at reporting, when initiated by triage nurse, the superior efficacy of inhaled methoxyflurane plus standard of care (m-SoC) analgesia versus placebo plus SoC (p-SoC) for moderate-to-severe trauma-related pain in the hospital ED.

METHODS

A randomised, double-blind, placebo-controlled trial was conducted at eight EDs. Adults with pain score ≥4 (11-point numerical rate scale, NRS) at admission were randomised to receive one or two inhalers containing m-SoC or p-SoC. Primary outcome measure was time until pain relief ≤30 mm, assessed on the 100-mm Visual Analogic Scale (VAS).

RESULTS

A total of 351 patients were analysed (178 m-SoC; 173 p-SoC). Median pain prior to first inhalation was 66 mm, 75% had severe pain (NRS 6-10). Median time to pain relief was 35 min [95% confidence interval (CI), 28-62] for m-SoC versus not reached in p-SoC (92 - not reached) [hazard ratio), 1.93 (1.43-2.60), P < 0.001]. Pain relief was most pronounced in the severe pain subgroup: hazard ratio, 2.5 (1.7-3.7). As SoC, 24 (7%) patients received weak opioids (6 versus 8%), 4 (1%) strong opioid and 44 (13%) escalated to weak or strong opioids (8 versus 17%, respectively, P = 0.02). Most adverse events were of mild (111/147) intensity.

CONCLUSIONS

In this study, we report that methoxyflurane, initiated at triage nurse as part of a multimodal analgesic approach, is effective in achieving pain relief for trauma patients. This effect was particularly pronounced in the severe pain subgroup.

摘要

背景

急诊室(ED)中经常出现镇痛不足的情况。本研究旨在报告由分诊护士启动的吸入甲氧氟烷联合标准治疗(m-SoC)与安慰剂联合标准治疗(p-SoC)对中度至重度创伤相关疼痛的疗效,m-SoC 用于医院 ED。

方法

在八个 ED 进行了一项随机、双盲、安慰剂对照试验。入院时疼痛评分≥4(11 点数字评分量表,NRS)的成年人被随机分配接受含有 m-SoC 或 p-SoC 的一个或两个吸入器。主要结局测量是疼痛缓解至≤30mm 的时间,使用 100mm 视觉模拟评分(VAS)进行评估。

结果

共分析了 351 名患者(178 名 m-SoC;173 名 p-SoC)。首次吸入前的中位数疼痛为 66mm,75%的患者有严重疼痛(NRS 6-10)。m-SoC 组的中位疼痛缓解时间为 35 分钟[95%置信区间(CI),28-62],而 p-SoC 组未达到缓解时间[92-未达到] [风险比],1.93(1.43-2.60),P<0.001]。在严重疼痛亚组中,疼痛缓解最为明显:风险比,2.5(1.7-3.7)。作为 SoC,24 名(7%)患者接受了弱阿片类药物(6 名与 8 名),4 名(1%)强阿片类药物和 44 名(13%)升级为弱或强阿片类药物(8 名与 17 名,分别为,P=0.02)。大多数不良事件为轻度(111/147)。

结论

在这项研究中,我们报告说,甲氧氟烷作为多模式镇痛方法的一部分,由分诊护士启动,可有效缓解创伤患者的疼痛。这种效果在严重疼痛亚组中尤为明显。

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