Helmerhorst Gijs T T, Zwiers Ruben, Ring David, Kloen Peter
1Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands 2Dell Medical School, the University of Texas at Austin, Austin, Texas.
J Bone Joint Surg Am. 2017 Nov 15;99(22):1908-1915. doi: 10.2106/JBJS.17.00149.
Opioid pain medication is frequently given to patients recovering from a surgical procedure for an extremity fracture in spite of evidence that acetaminophen may be adequate. The aim of this study was to determine whether prescription of step 1 pain medication (acetaminophen) is noninferior to step 2 pain medication (acetaminophen and tramadol) after operative treatment of an extremity fracture.
Fifty-two patients with a single extremity fracture were randomized from July 2012 to March 2015 in this 2-week follow-up, noninferiority trial in a level-I trauma center in the Netherlands. Patients were randomly assigned to receive step 1 (acetaminophen) or step 2 (acetaminophen and tramadol) medication in standard doses on an as-needed basis on discharge. Intention-to-treat and per-protocol analyses were conducted. The primary outcome was self-reported satisfaction with pain relief measured on an 11-point ordinal scale. The hypothesis being tested was formulated before the collection of data. The mean differences between the groups were reported for intention-to-treat and per-protocol analyses.
A total of 52 patients, with equal baseline characteristics, were analyzed in this study; the step 1 group consisted of 27 subjects and the step 2 group consisted of 25 subjects. The mean satisfaction with pain management was 8.3 for step 1 and 8.5 for step 2 medications. This mean difference of 0.2 point (95% confidence interval [CI], -0.78 to 1.30 points) did not exceed the noninferiority margin of 2.0 points, indicating that step 1 was noninferior to step 2. A similar result was found in the per-protocol analysis (mean difference, 0.2 point [95% CI, -1.03 to 1.57 points]).
This study offers evidence to suggest that prescription of acetaminophen is not inferior compared with acetaminophen and tramadol in patients who underwent operative treatment for an extremity fracture. Given that tramadol has more side effects and is potentially habit-forming, acetaminophen should be considered the mainstay for pain relief in patients recovering from extremity fracture surgical procedures.
Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
尽管有证据表明对乙酰氨基酚可能就足够了，但阿片类止痛药物仍经常用于接受肢体骨折手术的患者术后恢复过程中。本研究的目的是确定在肢体骨折手术治疗后，第一步止痛药物（对乙酰氨基酚）的处方是否不劣于第二步止痛药物（对乙酰氨基酚和曲马多）。
2012年7月至2015年3月，在荷兰一家一级创伤中心进行的这项为期2周的随访非劣效性试验中，52名单发肢体骨折患者被随机分组。患者出院时根据需要随机分配接受标准剂量的第一步（对乙酰氨基酚）或第二步（对乙酰氨基酚和曲马多）药物治疗。进行了意向性分析和符合方案分析。主要结局是用11点序数量表测量的患者自我报告的疼痛缓解满意度。所检验的假设在收集数据之前就已制定。报告了意向性分析和符合方案分析中两组之间的平均差异。
本研究共分析了52例基线特征相同的患者；第一步组有27名受试者，第二步组有25名受试者。第一步药物的疼痛管理平均满意度为8.3，第二步药物为8.5。这0.2分的平均差异（95%置信区间[CI]，-0.78至1.30分）未超过2.0分的非劣效性界值，表明第一步不劣于第二步。在符合方案分析中也发现了类似结果（平均差异，0.2分[95%CI，-1.03至1.57分]）。
本研究提供的证据表明，在接受肢体骨折手术治疗的患者中，对乙酰氨基酚处方与对乙酰氨基酚和曲马多相比并不逊色。鉴于曲马多有更多副作用且有潜在成瘾性，对乙酰氨基酚应被视为肢体骨折手术恢复患者止痛的主要药物。
治疗水平I。有关证据水平的完整描述，请参阅作者指南。
