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一项比较静脉注射氢吗啡酮与静脉注射对乙酰氨基酚治疗老年急性重度疼痛患者的随机研究。

A Randomized Study of Intravenous Hydromorphone Versus Intravenous Acetaminophen for Older Adult Patients with Acute Severe Pain.

机构信息

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

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

出版信息

Ann Emerg Med. 2022 Nov;80(5):432-439. doi: 10.1016/j.annemergmed.2022.06.016. Epub 2022 Aug 12.

DOI:10.1016/j.annemergmed.2022.06.016
PMID:35965162
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9588558/
Abstract

STUDY OBJECTIVE

We conducted a randomized study to compare the efficacy and adverse event profile of 1,000 mg of intravenous acetaminophen to that of 0.5 mg of intravenous hydromorphone among patients aged 65 years or more with acute pain of severity that was sufficient enough to warrant intravenous opioids.

METHODS

This randomized comparative effectiveness study with 162 participants was conducted in 2 urban emergency departments (EDs). The primary outcome was an improvement in a 0 to 10 pain scale from baseline to 60 minutes later. Secondary outcomes included the need for additional analgesic medication and adverse events that were attributable to the investigational medication. The minimum clinically important difference was an improvement of 1.3 on the 0 to 10 pain scale.

RESULTS

The median baseline pain score was 10 (interquartile range 8 to 10) in both the groups. By 60 minutes, patients taking acetaminophen improved by 3.6 (standard deviation 2.9) on the 0 to 10 pain scale, whereas patients taking hydromorphone improved by 4.6 (standard deviation 3.3) (95% confidence interval [CI] for the difference of 1.0 was 0.1 to 2.0). Additional analgesic medications were required for 37 (46%) of 81 patients taking acetaminophen and 31 (38%) of 81 patients taking hydromorphone (95% CI for the rounded difference of 7% was -8% to 23%). Adverse events were reported by 6 (7%) of 81 patients taking acetaminophen and 10 (12%) of 81 patients taking hydromorphone (95% CI for the difference of 5% was -4% to 14%) and included dizziness, drowsiness, headache, and nausea.

CONCLUSION

Although 0.5 mg of the intravenously administered hydromorphone was statistically superior to 1,000 mg of intravenous acetaminophen administered in older patients with acute severe pain in the ED, this difference was not clinically significant. Regardless of the medication received, many participants experienced minimal or incomplete pain relief.

摘要

研究目的

我们进行了一项随机研究,比较了静脉注射 1000 毫克对乙酰氨基酚和 0.5 毫克氢吗啡酮在 65 岁及以上因急性疼痛程度足以需要静脉使用阿片类药物的患者中的疗效和不良事件谱。

方法

这是一项在 2 家城市急诊部(ED)进行的 162 名参与者随机比较有效性研究。主要结局是从基线到 60 分钟后,0 到 10 疼痛量表的改善。次要结局包括需要额外的镇痛药物和与研究药物相关的不良事件。最小临床重要差异为 0 到 10 疼痛量表上的改善 1.3。

结果

两组患者的基线疼痛评分中位数均为 10(四分位距 8 至 10)。在 60 分钟时,接受对乙酰氨基酚治疗的患者疼痛评分从 0 到 10 改善了 3.6(标准差 2.9),而接受氢吗啡酮治疗的患者疼痛评分改善了 4.6(标准差 3.3)(差异的 95%置信区间为 1.0 是 0.1 至 2.0)。81 名接受对乙酰氨基酚治疗的患者中有 37 名(46%)和 81 名接受氢吗啡酮治疗的患者中有 31 名(38%)需要额外的镇痛药物(95%置信区间的圆形差异为 7%为 -8%至 23%)。接受对乙酰氨基酚治疗的 81 名患者中有 6 名(7%)和接受氢吗啡酮治疗的 81 名患者中有 10 名(12%)报告了不良事件(95%置信区间的差异为 5%为 -4%至 14%),包括头晕、嗜睡、头痛和恶心。

结论

尽管静脉注射 0.5 毫克氢吗啡酮在 ED 中治疗急性严重疼痛的老年患者中在统计学上优于静脉注射 1000 毫克对乙酰氨基酚,但这种差异无临床意义。无论接受何种药物治疗,许多患者的疼痛缓解都不明显或不完全。

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