Comparative Analgesic Efficacy of Oxycodone/Acetaminophen vs Codeine/Acetaminophen for Short-Term Pain Management Following ED Discharge
Comparative Analgesic Efficacy of Oxycodone/Acetaminophen vs Codeine/Acetaminophen for Short-Term Pain Management Following ED Discharge
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DOI：
10.1111/pme.12830
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发表时间：
2015-12-01
期刊：
影响因子：
3.1
通讯作者：
Gallagher, E. John
中科院分区：
文献类型：
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作者：
Chang, Andrew K.;Bijur, Polly E.;Gallagher, E. John
目标。目的：验证羟考酮/对乙酰氨基酚在急诊科出院后止痛效果优于可待因/对乙酰氨基酚的假设。前瞻性，随机，双盲，试验。设置。成人内城ED.科目。急性期肢体疼痛出院的ED患者。患者随机分为羟考酮/对乙酰氨基酚(5 mg/325 mg)或可待因/对乙酰氨基酚(30 mg/300 mg)。在ED出院后一天通过电话获得的主要结果是，在最近一次摄入研究药物后的2小时内，两组之间在数字分级量表(NRS)疼痛评分改善方面的差异。次要结果包括疼痛减轻50%的患者比例、副作用概况和患者满意度。240例患者入选。两组的平均基线NRS评分均为7.9分。羟考酮/对乙酰氨基酚组在2小时内的平均下降量为4.5NRS单位，而可待因/对乙酰氨基酚组为4.2NRS单位，两者在临床上和统计学上无显著差异(95%CI-0.4-0.9NRS单位)。同样，66%和61%的患者获得了50%的疼痛缓解，5%的差异不显著(95%的可信区间为8%，17%的差异为17%)。不良反应情况与患者满意度相似。我们认为羟考酮/对乙酰氨基酚的止痛效果优于可待因/对乙酰氨基酚的假说被驳回。尽管每组内的疼痛都减少了一半以上，但组间的差异并不显著。在等待独立验证之前，这些意想不到的发现表明，可待因/对乙酰氨基酚，一种附表III药物，可能是羟考酮/对乙酰氨基酚的临床合理门诊阿片类药物替代品，羟考酮/对乙酰氨基酚是一种更严格限制的附表II药物，被认为更容易滥用。
Objective. To test the hypothesis that oxycodone/acetaminophen provides analgesia superior to codeine/acetaminophen following emergency department (ED) discharge.Design. Prospective, randomized, double-blind, trial.Setting. Adult inner city ED.Subjects. ED patients with acute extremity pain who were discharged home.Methods. Patients randomized to oxycodone/acetaminophen (5 mg/325 mg) or codeine/acetaminophen (30 mg/300 mg). The primary outcome, obtained via telephone one day after ED discharge, was the between-group difference in improvement in numerical rating scale (NRS) pain scores over a 2-hour period following the most recent ingestion of study drug. Secondary outcomes included proportion of patients with >50% pain reduction, side-effect profile, and patient satisfaction.Results. Two hundred and forty patients were enrolled. Mean baseline NRS scores were 7.9 in both groups. Mean decrease over 2 hours was 4.5 NRS units in the oxycodone/acetaminophen group vs 4.2 NRS units in the codeine/acetaminophen group, for a clinically and statistically nonsignificant difference of 0.2 NRS units (95% CI -0.4-0.9 NRS units). Similarly, 66% vs 61% achieved >50% pain relief for a nonsignificant difference of 5% (95% CI -8% to 17%). Side-effect profile and patient satisfaction were similar.Conclusion. Our hypothesis that oxycodone/acetaminophen provides analgesia superior to codeine/acetaminophen was rejected. Although pain within each group was reduced by more than half, the between-group difference was not significant. Pending independent validation, these unexpected findings suggest that codeine/acetaminophen, a Schedule III agent, may be a clinically reasonable outpatient opioid alternative to oxycodone/acetaminophen, a more tightly restricted Schedule II agent thought to be more prone to misuse.