School of Dental Medicine, Rutgers University, Newark, NJ, USA.
School of Public Health, Rutgers University, Newark, NJ, USA.
JDR Clin Trans Res. 2024 Jan;9(1):72-84. doi: 10.1177/23800844221144031. Epub 2023 Jan 20.
With addiction rates and opioid deaths increasing, health care providers are obligated to help stem the opioid crisis. As limited studies examine the comparative effectiveness of fixed-dose combination nonopioid analgesia to opioid-containing analgesia, a comparative effectiveness study was planned and refined by conducting a pilot study.
The Opioid Analgesic Reduction Study (OARS) pilot, a stratified, randomized, multisite, double-blind clinical trial, was designed to test technology and procedures to be used in the full OARS trial. Participants engaged in the full protocol, enabling the collection of OARS outcome data. Eligible participants reporting to 1 of 5 sites for partial or full bony impacted mandibular third molar extraction were stratified by biologic sex and randomized to 1 of 2 treatment groups, OPIOID or NONOPIOID. OPIOID participants were provided 20 doses of hydrocodone 5 mg/acetaminophen 300 mg. NONOPIOID participants were provided 20 doses of ibuprofen 400 mg/acetaminophen 500 mg. OARS outcomes data, including pain experience, adverse effects, sleep quality, pain interference, overall satisfaction, and remaining opioid tablets available for diversion, were collected via surveys, electronic medication bottles, eDiary, and activity/sleep monitor.
Fifty-three participants were randomized with 50 completing the OARS pilot protocol. Across all outcome pain domains, in all but 1 time period, NONOPIOID was better in managing pain than OPIOID ( < 0.05 level). Other outcomes suggest less pain interference, less adverse events, better sleep quality, better overall satisfaction, and fewer opioid-containing tablets available for diversion.
Results suggest patients requiring impacted mandibular third molar extraction would benefit from fixed-dose combination nonopioid analgesia.
Study results suggest fixed-dose nonopioid combination ibuprofen 400 mg/acetaminophen 500 mg is superior to opioid-containing analgesic (hydrocodone 5 mg/acetaminophen 500 mg). This knowledge should inform surgeons and patients in the selection of postsurgical analgesia.
随着成瘾率和阿片类药物死亡人数的增加，医疗保健提供者有义务帮助遏制阿片类药物危机。由于有限的研究检查了固定剂量组合非阿片类镇痛药与含阿片类镇痛药的相对有效性，因此计划并通过进行试点研究来完善一项相对有效性研究。
阿片类药物镇痛减少研究 (OARS) 试点是一项分层、随机、多地点、双盲临床试验，旨在测试将在完整的 OARS 试验中使用的技术和程序。参与者参与完整的方案，能够收集 OARS 结果数据。符合条件的参与者向 5 个地点中的 1 个报告进行部分或完全骨内下颌第三磨牙提取，根据生物性别分层并随机分为 2 个治疗组，阿片类药物或非阿片类药物。阿片类药物组提供 20 剂氢可酮 5 毫克/对乙酰氨基酚 300 毫克。非阿片类药物组提供 20 剂布洛芬 400 毫克/对乙酰氨基酚 500 毫克。通过调查、电子药瓶、电子日记和活动/睡眠监测器收集 OARS 结果数据，包括疼痛体验、不良反应、睡眠质量、疼痛干扰、整体满意度和剩余可用于转移的阿片类药物片剂。
53 名参与者被随机分配，其中 50 名完成了 OARS 试点方案。在所有疼痛领域的结果中，除了 1 个时间段外，非阿片类药物在管理疼痛方面都优于阿片类药物（<0.05 水平）。其他结果表明疼痛干扰较小、不良反应较少、睡眠质量较好、整体满意度较高且剩余的阿片类药物片剂可用于转移。
结果表明，需要进行下颌第三磨牙提取的患者将受益于固定剂量组合的非阿片类镇痛药。
研究结果表明，固定剂量非阿片类药物组合布洛芬 400 毫克/对乙酰氨基酚 500 毫克优于含阿片类镇痛药（氢可酮 5 毫克/对乙酰氨基酚 500 毫克）。这一知识应该为外科医生和患者在选择术后镇痛剂时提供信息。
