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一项评估甲氧氟烷用于骨髓穿刺活检操作疼痛的安全性和有效性的随机、双盲、安慰剂对照研究。

A randomised, double-blind, placebo-controlled study to assess the safety and efficacy of methoxyflurane for procedural pain of a bone marrow biopsy.

作者信息

Spruyt Odette, Westerman David, Milner Alvin, Bressel Mathias, Wein Simon

机构信息

Department of Pain and Palliative Care, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.

Department of Haematology, Peter MacCallum Cancer Centre/University of Melbourne, Melbourne, Victoria, Australia.

出版信息

BMJ Support Palliat Care. 2014 Dec;4(4):342-8. doi: 10.1136/bmjspcare-2013-000447. Epub 2013 Jun 7.

DOI:10.1136/bmjspcare-2013-000447
PMID:24644183
Abstract

CONTEXT

Pain during bone marrow biopsy (BMB) under local anaesthesia (LA) is reported in 70% of patients, of whom 35% rate the pain as severe. Pain is experienced during both the biopsy and the marrow aspiration. Many medical centres use conscious sedation involving benzodiazepines and/or opioids administered orally or intravenously for BMB analgesia. Methoxyflurane (MEOF) is self-administered by a handheld device (the Penthrox inhaler), which is licensed in Australia for the relief of pain associated with short surgical procedures.

OBJECTIVES

To evaluate the efficacy and safety of MEOF analgesia in patients with cancer undergoing BMB.

METHODS

Patients received LA plus either MEOF or placebo. The primary endpoint was worst pain intensity measured with the Numerical Rating Scale. Anxiety was assessed with the State Trait Anxiety Inventory (STAI-Y-1). Patients, operators and the research nurse rated global medication performance using a 5-point Likert scale.

RESULTS

Forty-nine of the 50 patients randomised to MEOF and 48 of the 50 patients randomised to placebo effectively received the allocated intervention. Mean±SD worst pain overall was 4.90±2.07 in MEOF group and 6.0±2.24 in placebo group (p=0.011). Worst pain during the aspiration was 3.3±2.0 in MEOF group and 5.0±2.4 in placebo group (p<0.001). 49% of patients treated with MEOF rated the medication as very good or excellent compared with 16.5% of the patients treated with placebo (p=0.005). 20.4% of patients treated with MEOF had an adverse event (AE) compared with 4.2% in the placebo arm (p=0.028). All AEs were grade 1.

CONCLUSIONS

MEOF was safe and performed better than placebo for analgesia in BMB procedures.

摘要

背景

据报道,70%接受局部麻醉(LA)下骨髓活检(BMB)的患者会感到疼痛,其中35%的患者认为疼痛严重。活检和骨髓抽吸过程中都会出现疼痛。许多医疗中心使用包括口服或静脉注射苯二氮卓类药物和/或阿片类药物的清醒镇静来进行BMB镇痛。甲氧氟烷(MEOF)由手持设备(Penthrox吸入器)自行给药,该设备在澳大利亚获得许可,用于缓解与短期手术相关的疼痛。

目的

评估MEOF镇痛对接受BMB的癌症患者的疗效和安全性。

方法

患者接受LA加MEOF或安慰剂。主要终点是用数字评定量表测量的最严重疼痛强度。使用状态特质焦虑量表(STAI-Y-1)评估焦虑情况。患者、操作人员和研究护士使用5点李克特量表对整体药物疗效进行评分。

结果

随机分配至MEOF组的50名患者中有49名、随机分配至安慰剂组的50名患者中有48名有效接受了分配的干预措施。MEOF组总体最严重疼痛的平均值±标准差为4.90±2.07,安慰剂组为6.0±2.24(p=0.011)。抽吸过程中最严重疼痛在MEOF组为3.3±2.0,安慰剂组为5.0±2.4(p<0.001)。接受MEOF治疗的患者中有49%将药物评为非常好或优秀,而接受安慰剂治疗的患者中这一比例为16.5%(p=0.005)。接受MEOF治疗的患者中有20.4%发生不良事件(AE),而安慰剂组为4.2%(p=0.028)。所有不良事件均为1级。

结论

在BMB手术中,MEOF用于镇痛安全且效果优于安慰剂。

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