The Opioid Analgesic Reduction Study (OARS)-a comparison of opioid vs. non-opioid combination analgesics for management of post-surgical pain: a double-blind randomized clinical trial.
The Opioid Analgesic Reduction Study (OARS)-a comparison of opioid vs. non-opioid combination analgesics for management of post-surgical pain: a double-blind randomized clinical trial.
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DOI：
10.1186/s13063-022-06064-8
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发表时间：
2022-02-17
期刊：
影响因子：
2.5
通讯作者：
Fine D
中科院分区：
文献类型：
--
作者：
Feldman CA;Fredericks-Younger J;Lu SE;Desjardins PJ;Malmstrom H;Miloro M;Warburton G;Ward B;Ziccardi V;Fine D
每天都有人死于阿片类药物过量相关的成瘾。牙医是阿片类镇痛药的主要处方者之一。阿片类药物寻求行为与在第三磨牙拔除的常见牙科手术后接受初始阿片类药物处方有关。随着每一个阿片类药物处方，患者的阿片类药物误用或滥用的风险增加。据估计，在美国，每年在第三磨牙拔除后开出5600万片5 mg氢可酮，350万年轻人可能不必要地暴露于牙医的阿片类药物，这些牙医无意中增加了患者的成瘾风险。设计了一项双盲、分层随机、多中心临床试验，以评估非处方非阿片类镇痛药的组合是否不劣于最常用的阿片类镇痛药。由于术后疼痛的可预测严重程度和结果的普遍性，正在使用阻生第三磨牙拔除模型。在每个研究中心/诊所和性别类型（男性/女性）内，患者随机接受阿片类药物（氢可酮/对乙酰氨基酚5/300 mg）或非阿片类药物（布洛芬/对乙酰氨基酚400/500 mg）。结果数据包括疼痛水平、不良事件、患者总体满意度、睡眠能力和日常功能。为了制定临床指南和临床决策工具，正在收集疼痛管理、拔牙难度和服用药片的数量，以便能够开发实验性决策工具。所提出的方法解决了其他镇痛研究的缺点。虽然之前的研究已经测试了单剂量止痛药的短期效果，但患者和他们的牙医对整个术后期间的疼痛管理感兴趣，而不仅仅是前12小时。手术后，患者希望能够进行正常的日常功能，而不会感到恶心或头晕，他们希望在晚上睡个安稳觉。年轻人的父母担心阿片类药物使用和滥用的风险，这与接受的治疗或随后使用剩余药丸有关。在成功完成这项临床试验后，牙医，患者及其家属将能够更好地做出关于术后疼痛管理的明智决定。ClinicalTrials.govNCT04452344.注册日期：2020年6月20日
Everyday people die unnecessarily from opioid overdose-related addiction. Dentists are among the leading prescribers of opioid analgesics. Opioid-seeking behaviors have been linked to receipt of initial opioid prescriptions following the common dental procedure of third molar extraction. With each opioid prescription, a patient’s risk for opioid misuse or abuse increases. With an estimated 56 million tablets of 5 mg hydrocodone annually prescribed after third molar extractions in the USA, 3.5 million young adults may be unnecessarily exposed to opioids by dentists who are inadvertently increasing their patient’s risk for addiction. A double-blind, stratified randomized, multi-center clinical trial has been designed to evaluate whether a combination of over-the-counter non-opioid-containing analgesics is not inferior to the most prescribed opioid analgesic. The impacted 3rd molar extraction model is being used due to the predictable severity of the post-operative pain and generalizability of results. Within each site/clinic and gender type (male/female), patients are randomized to receive either OPIOID (hydrocodone/acetaminophen 5/300 mg) or NON-OPIOID (ibuprofen/acetaminophen 400/500 mg). Outcome data include pain levels, adverse events, overall patient satisfaction, ability to sleep, and ability to perform daily functions. To develop clinical guidelines and a clinical decision-making tool, pain management, extraction difficulty, and the number of tablets taken are being collected, enabling an experimental decision-making tool to be developed. The proposed methods address the shortcomings of other analgesic studies. Although prior studies have tested short-term effects of single doses of pain medications, patients and their dentists are interested in managing pain for the entire post-operative period, not just the first 12 h. After surgery, patients expect to be able to perform normal daily functions without feeling nauseous or dizzy and they desire a restful sleep at night. Parents of young people are concerned with the risks of opioid use and misuse, related either to treatments received or to subsequent use of leftover pills. Upon successful completion of this clinical trial, dentists, patients, and their families will be better able to make informed decisions regarding post-operative pain management. ClinicalTrials.govNCT04452344. Registered on June 20, 2020
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7.4
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