Effectiveness of Oxycodone Hydrochloride (Strong Opioid) vs Combination Acetaminophen and Codeine (Mild Opioid) for Subacute Pain After Fractures Managed Surgically: A Randomized Clinical Trial.
Effectiveness of Oxycodone Hydrochloride (Strong Opioid) vs Combination Acetaminophen and Codeine (Mild Opioid) for Subacute Pain After Fractures Managed Surgically: A Randomized Clinical Trial.
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DOI：
10.1001/jamanetworkopen.2021.34988
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发表时间：
2021-11-01
影响因子：
13.8
通讯作者：
Harris IA
中科院分区：
文献类型：
--
作者：
Jenkin DE;Naylor JM;Descallar J;Harris IA
这项随机临床试验比较了强效阿片类药物(盐酸羟考酮)和轻度阿片类药物(扑热息痛、可待因联合)对骨折骨科手术患者出院后亚急性疼痛的疗效。在接受骨科手术治疗的患者出院后服用强阿片类药物(盐酸羟考酮5 mg或10 mg，每天4次)是否比轻度阿片类药物(对乙酰氨基酚可待因联合500 mg和8 mg或1000 mg和16 mg 4次)具有更好的止痛效果？在这项对120例需要手术固定的1例或1例以上急性骨科骨折患者的随机临床试验中，从出院后第1天到第7天，强阿片组和轻度阿片组的日平均疼痛评分分别为4.04和4.54。尽管在强阿片组中阿片类药物的剂量增加了6倍，但组间的差异在统计上和临床上都没有显著意义。这项研究发现，在治疗的前7天，羟考酮并没有提供比对乙酰氨基酚和可待因联合使用的更好的止痛效果，尽管在强阿片组中给予的阿片类药物剂量是对照组的6倍。接受手术治疗的骨折患者通常会带着强烈的阿片类药物处方出院，但支持这种做法的证据有限。目的：验证强阿片类药物在骨折手术后出院后第一周内比轻度类阿片类药物具有更强的止痛作用的假设。这项双盲、优势、随机的临床试验在澳大利亚悉尼的一家单中心大型创伤医院进行。参与者是在2016年7月27日至2017年8月22日期间接受手术固定治疗的长骨或骨盆、膝盖骨、跟骨或距骨急性非病理性骨折的住院患者。对2018年6月至10月的数据进行了分析。在出院时开始注射盐酸羟考酮5 mg 10 mg(即1或2片)或扑热息痛和可待因500 mg和8 mg或1000 mg和16 mg(即1或2片)，每日4次，最长持续3周。主要结果是在治疗1周期间收集的每日疼痛评分的平均值，使用数字疼痛评级量表(NRS)进行测量。参与者被要求使用从0到10的NRS分数对他们在过去24小时内的平均疼痛进行评分，0分代表没有疼痛，10分代表可以想象到的最严重的疼痛。关键的次要结果是EuroQol 5维5级问卷(EQ-5D-5L)的反应、最严重的疼痛、药物不良事件、总体感知效果和重返工作岗位。共120例需要手术固定的急性骨科骨折患者被随机分为两组，其中强阿片组59例(男性43例，占72.9%；平均年龄36.0[14.1]岁；第1~7天平均口服吗啡当量32.9 mg)；轻度阿片组61例(男性47例，占77.1%；平均[SD]年龄38.2[13.5]岁；第1~7天平均口服吗啡当量5.5 mg)。出院后第1~7天，强效阿片组和轻度阿片组的平均每日NRS疼痛评分分别为4.04(95%CI，3.67~4.41)和4.54(95%CI，4.17~4.90)。尽管强阿片类药物组的阿片类药物剂量增加了6倍，但两组之间的主要结果差异无统计学意义(−0.50[95%氯，−1.11至0.12]；P = .11)。这项研究发现，在手术治疗的骨科骨折患者中，亚急性使用强阿片类药物治疗并不优于使用较温和的药物治疗疼痛。这些发现表明，出院后持续的一线强阿片类药物使用不应得到支持。澳大利亚新西兰临床试验注册号：ACTRN12616000941460
This randomized clinical trial compares the effectiveness of a strong opioid (oxycodone hydrochloride) vs a mild opioid (acetaminophen codeine combination) when taken postdischarge for subacute pain among patients who underwent orthopedic surgical treatment for fracture. Does a strong opioid (oxycodone hydrochloride 5 mg or 10 mg 4 times daily) provide better analgesia than a mild opioid (acetaminophen codeine combination 500 mg and 8 mg or 1000 mg and 16 mg 4 times daily) when taken postdischarge among patients who underwent orthopedic surgical treatment? In this randomized clinical trial of 120 patients with 1 or more acute orthopedic fractures requiring surgical fixation, the mean of daily mean pain scores from day 1 to 7 postdischarge was 4.04 in the strong opioid group and 4.54 in the mild opioid group. The between-group difference was neither statistically nor clinically significant despite a 6-fold higher dose of opioid being delivered in the strong opioid group. This study found that oxycodone did not provide superior pain relief compared with combination acetaminophen and codeine during the first 7 days of treatment despite a 6-fold higher dose of opioid being delivered in the strong opioid group. Patients with a surgically managed fracture are commonly discharged from the hospital with a strong opioid prescription, but limited evidence exists to support this practice. To test the hypothesis that strong opioids provide greater analgesia than mild opioids over the first week postdischarge from hospital after fracture surgical treatment. This double-blind, superiority, randomized clinical trial was conducted at a single-center, major trauma hospital in Sydney, Australia. Participants were inpatients who had sustained an acute nonpathological facture of a long bone or the pelvis, patella, calcaneus, or talus who were treated with surgical fixation and enrolled from July 27, 2016, to August 22, 2017. Data were analyzed from June through October 2018. Initiation at discharge of oxycodone hydrochloride 5 mg of 10 mg (ie, 1 or 2 tablets) or combination acetaminophen and codeine 500 mg and 8 mg or 1000 mg and 16 mg (ie, 1 or 2 tablets) 4 times daily for a maximum duration of 3 weeks. The primary outcome was the mean of daily pain scores collected during week 1 of treatment measured using the Numerical Pain Rating Scale (NRS). Participants were asked to rate their mean pain over the previous 24 hours daily using an NRS score from 0 to 10, with 0 representing no pain and 10 representing the worst pain imaginable. The key secondary outcomes were EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) responses, worst pain, medication adverse events, global perceived effect, and return to work. A total of 120 patients with 1 or more acute orthopedic fractures requiring surgical fixation were randomized, including 59 patients in the strong-opioid group (43 [72.9%] men; mean [SD] age, 36.0 [14.1] years; mean oral morphine equivalent for days 1-7 of 32.9 mg) and 61 patients in the mild opioid group (47 [77.1%] men; mean [SD] age, 38.2 [13.5] years; mean oral morphine equivalent for days 1-7 of 5.5 mg). From days 1 to 7 postdischarge, the mean daily NRS mean pain score was 4.04 (95% Cl, 3.67 to 4.41) in the strong opioid group and 4.54 (95% Cl, 4.17 to 4.90) in the mild opioid group. The between-group difference of the primary outcome was not statistically significant (−0.50 [95% Cl, −1.11 to 0.12]; P = .11) despite a 6-fold increased dose of opioids being delivered in the strong opioid group. This study found that treatment with strong opioid medication subacutely was not superior to treatment with milder medication for treatment of pain among patients with surgically managed orthopedic fractures. These findings suggest that ongoing first-line strong opioid use after discharge from the hospital should not be supported. Australia New Zealand Clinical Trial Registry No.: ACTRN12616000941460
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影响因子：
4.4
作者：
Chang, Andrew K.;Bijur, Polly E.;Gallagher, E. John
通讯作者：
Gallagher, E. John
影响因子：
14.6
作者：
Dhalla, Irfan A.;Mamdani, Muhammad M.;Juurlink, David N.
通讯作者：
Juurlink, David N.
DOI：
10.1016/j.jpain.2017.06.010
发表时间：
2017-11
期刊：
The journal of pain
影响因子：
--
作者：
Shah A;Hayes CJ;Martin BC
通讯作者：
Martin BC
影响因子：
3.1
作者：
Chang, Andrew K.;Bijur, Polly E.;Gallagher, E. John
通讯作者：
Gallagher, E. John
DOI：
10.1017/cbo9780511576706.016
发表时间：
2009-01-01
期刊：
ACUTE PAIN MANAGEMENT
影响因子：
--
作者：
Macintyre, Pamela E.;Coldrey, Julia
通讯作者：
Coldrey, Julia