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随机临床试验:2 毫克氢吗啡酮推注方案与“1+1”氢吗啡酮滴定方案在急诊科就诊后 1 小时内治疗急性剧烈疼痛的比较。

Randomized clinical trial of the 2 mg hydromorphone bolus protocol versus the "1+1" hydromorphone titration protocol in treatment of acute, severe pain in the first hour of emergency department presentation.

机构信息

Department of Emergency Medicine, Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, NY.

出版信息

Ann Emerg Med. 2013 Oct;62(4):304-10. doi: 10.1016/j.annemergmed.2013.02.023. Epub 2013 May 18.

Abstract

STUDY OBJECTIVE

We compare a high initial dose of 2 mg intravenous hydromorphone against titration of 1 mg intravenous hydromorphone followed by an optional second dose.

METHODS

Patients aged 21 to 64 years with severe pain were randomly allocated to 2 mg intravenous hydromorphone in a single bolus or the "1+1" hydromorphone titration protocol. 1+1 Patients received 1 mg intravenous hydromorphone followed by a second 1 mg dose 15 minutes later if they answered yes when asked, Do you want more pain medication? The primary outcome was the between-group difference in proportion of patients who declined additional analgesia at 60 minutes.

RESULTS

Of the 350 enrolled patients, 334 had sufficient data for analysis. The proportion who declined additional analgesics was 67.5% in the 2 mg bolus arm and 67.3% in the 1+1 titration arm (difference 0.2%; 95% confidence interval -9.7% to 10.2%). The between-group difference in numeric rating scale pain scores was 0.4 numeric rating scale units (95% confidence interval -0.3 to 1.1). The incidence of adverse effects was similar; 42.3% of 1+1 patients achieved satisfactory analgesia at 1 hour with only 1 mg hydromorphone.

CONCLUSION

A hydromorphone 1+1 titration protocol provides similar pain relief to an initial 2 mg bolus dose, with no apparent clinical advantage to the latter. The 1+1 titration protocol had an opioid-sparing effect because 50% less opioid was needed to achieve satisfactory analgesia for 42.3% of patients allocated to this protocol.

摘要

研究目的

我们比较了静脉注射氢吗啡酮 2 毫克高起始剂量与滴定至 1 毫克静脉注射氢吗啡酮后加用可选第二剂量的疗效。

方法

年龄在 21 至 64 岁之间的重度疼痛患者被随机分配至接受 2 毫克静脉注射氢吗啡酮单次推注或“1+1”氢吗啡酮滴定方案。1+1 方案组患者接受 1 毫克静脉注射氢吗啡酮,如果他们回答“是”,即“您是否需要更多的止痛药物?”,则 15 分钟后给予第二剂 1 毫克氢吗啡酮。主要结局是两组患者在 60 分钟时拒绝额外镇痛药物的比例。

结果

在纳入的 350 例患者中,334 例有足够的数据进行分析。在 2 毫克推注组中,拒绝额外镇痛药物的比例为 67.5%,在 1+1 滴定组中为 67.3%(差异 0.2%;95%置信区间 -9.7%至 10.2%)。数字评分量表疼痛评分的组间差异为 0.4 数字评分量表单位(95%置信区间 -0.3 至 1.1)。不良反应发生率相似;1+1 组 42.3%的患者在 1 小时时仅使用 1 毫克氢吗啡酮即达到满意的镇痛效果。

结论

氢吗啡酮 1+1 滴定方案与初始 2 毫克推注剂量提供相似的疼痛缓解效果,后者没有明显的临床优势。1+1 滴定方案具有阿片类药物节省效应,因为分配至该方案的 50%患者需要较少的阿片类药物即可达到 42.3%患者满意的镇痛效果。

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