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.

中文翻译：

---

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剧烈疼痛患者的随机研究

学习目的

我们进行了一项随机研究，比较 65 岁或以上患有足以需要静脉注射阿片类药物的严重急性疼痛的患者中 1,000 毫克静脉注射对乙酰氨基酚与 0.5 毫克静脉注射氢吗啡酮的疗效和不良事件情况。

方法

这项随机比较有效性研究在 2 个城市急诊科 (ED) 进行，共有 162 名参与者参加。主要结果是 60 分钟后疼痛等级从基线到 0 到 10 的改善。次要结局包括需要额外的镇痛药物以及由研究药物引起的不良事件。最小的临床重要差异是 0 至 10 级疼痛等级改善 1.3。

结果

两组的基线疼痛评分中位数均为 10（四分位数范围为 8 至 10）。60 分钟时，服用对乙酰氨基酚的患者在 0 至 10 级疼痛等级上改善了 3.6（标准差 2.9），而服用氢吗啡酮的患者改善了 4.6（标准差 3.3）（1.0 差异的 95% 置信区间 [CI] 为 0.1）至 2.0）。81 名服用对乙酰氨基酚的患者中有 37 名（46%）需要额外的镇痛药物，81 名服用氢吗啡酮的患者中有 31 名（38%）需要额外的镇痛药物（7% 的四舍五入差异的 95% CI 为 -8% 至 23%）。服用对乙酰氨基酚的 81 名患者中有 6 名（7%）报告了不良事件，服用氢吗啡酮的 81 名患者中有 10 名（12%）报告了不良事件（5% 差异的 95% CI 为 -4% 至 14%），包括头晕、嗜睡、头痛和恶心。

结论

尽管对于急诊室急性重度疼痛的老年患者来说，0.5 mg 静脉注射氢吗啡酮在统计学上优于 1,000 mg 静脉注射对乙酰氨基酚，但这种差异在临床上并不显着。无论接受何种药物，许多参与者的疼痛缓解程度甚微或不完全。