Opiod Analgesic Reduction Study (OARS): Managing Acute Post-Operative Surgical Pain

阿片类镇痛减量研究 (OARS)：管理术后急性手术疼痛

• 批准号: 10670330
• 负责人: Cecile Feldman
• 金额: $ 113.08万
• 依托单位: RUTGERS BIOMEDICAL AND HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-08-01 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10670330
• 关键词: Acetaminophen; Acute; Acute Pain; Acute pain management; Address; Adolescent and Young Adult; Adverse effects; Adverse event; Adverse reactions; Age; Analgesics; Behavior; Caring; Client satisfaction; Clinic; Clinical; Clinical Protocols; Constipation; Data; Databases; Decision Making; Dental; Dental Care; Dentists; Diarrhea; Dizziness; Dose; Double-Blind Method; Drowsiness; Educational Status; Electronics; Emergency Situation; Ethnic Origin; Euphoria; Exhibits; Exposure to; Family; Feeling; Female; Frequencies; Future; Gender; Guidelines; Habits; Headache; Health Personnel; Health Professional; High School Student; Hour; Household; Hydrocodone; Hydrocodone/Acetaminophen; Ibuprofen; Light; Lightheadedness; Location; Mandible; Maxilla; Measures; Medical Electronics; Methods; Modeling; Monitor; Nausea; Operative Surgical Procedures; Opioid; Opioid Analgesics; Outcome; Pain; Pain Threshold; Pain management; Parents; Patient risk; Patients; Pattern; Persons; Polysomnography; Postoperative Pain; Postoperative Period; Pragmatic clinical trial; Pruritus; Race; Randomized; Recommendation; Reporting; Risk; School-Age Population; Serious Adverse Event; Severities; Site; Sleep; Tablets; Testing; Time; United States; Urinary Retention; Visit; Vomiting; Writing; addiction; capsule; clinical decision-making; daily functioning; diaries; expectation; experience; high school; interest; male; monitoring device; non-opioid analgesic; opioid abuse; opioid misuse; opioid mortality; opioid overdose; opioid use; pain model; pain patient; pain relief; pain sensitivity; pill; prescription opioid; programs; prospective; randomized, clinical trials; satisfaction; sleep quality; support tools; surgical pain; third molar extraction; tool; young adult

Project Summary/Abstract Everyday people die unnecessarily from opioid overdose-related addiction. 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 United States, 3.5 million young adults may be unnecessarily exposed to opioids by dentists who are increasing their patient’s risk for addiction. To provide health care professionals, including dentists, and their patients with the best possible evidence for clinical based decision making when deciding upon analgesics for acute post-surgical pain management, we propose a double blind, stratified randomized clinical trial to demonstrate a combination of over-the-counter non-opioid containing analgesics is not inferior to than the most commonly prescribed opioid analgesic. Patients will be randomized within each study site/clinic, and stratified based upon gender due to differences in prescribing patterns and pain tolerance. We will use the impacted 3rd molar extraction model due to the predictable severity of the post-operative pain and generalizability of results. Within each site/clinic and gender type (male/female), patients will be randomized to receive either OPIOID (hydrocodone/acetaminophen) or NON-OPIOID (ibuprofen/acetaminophen). Outcomes 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 number of tablets taken will be collected enabling an experimental decision making tool to be developed. The proposed methods address the short comings 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 acute pain for the entire post-operative period, not just the first 12 hours. They care about their ability to perform their normal daily functions without feeling queasy or nauseous, and they care about their ability to sleep at night. Parents of young people also care about the risks of subsequent opioid use, either related to treatments received or to subsequent use of leftover pills, which we will capture with objective measures of subsequent opioid prescriptions using PDMP data. This study would be the first to address these short comings. Upon successful completion of our proposed pragmatic clinical trial, patients and their families will be better able to make informed decisions regarding what pain medication (opioid vs. non-opioid) will best manage their pain after a dental procedure and will have a better understanding of the potential risks associated with opioid prescriptions.

项目总结/摘要 每天都有人死于阿片类药物过量相关的成瘾。每种阿片类药物处方 患者误用或滥用阿片类药物的风险增加。估计有5600万片5毫克氢可酮 在美国，每年有350万年轻人在第三磨牙拔除后被开处方， 牙医不必要地接触阿片类药物，增加了患者成瘾的风险。 为包括牙医在内的医疗保健专业人员及其患者提供最佳证据 对于在决定用于急性手术后疼痛管理的镇痛剂时基于临床的决策， 我们提出了一个双盲，分层随机临床试验，以证明非处方药的组合， 不含阿片样物质的镇痛剂不劣于最常用的阿片样物质镇痛剂。 患者将在每个研究中心/诊所内随机分配，并根据性别分层，原因是 处方模式和疼痛耐受性的差异。我们将使用阻生第三磨牙拔除模型， 术后疼痛的可预测严重程度和结果的普遍性。在每个研究中心/诊所内， 性别类型（男性/女性），患者将随机接受阿片类药物 （氢可酮/对乙酰氨基酚）或非阿片类药物（布洛芬/对乙酰氨基酚）。结局数据包括疼痛 水平、不良事件、总体患者满意度、睡眠能力和执行日常功能的能力。到 制定临床指南和临床决策工具，疼痛管理，拔牙困难， 将收集服用的药片数量，以便开发实验性决策工具。 所提出的方法解决了其他镇痛药研究的短期问题。尽管先前的研究 测试单剂量止痛药的短期效果，患者和他们的牙医感兴趣的是， 在整个手术后期间管理急性疼痛，而不仅仅是最初的12小时。他们关心他们的 能够执行正常的日常功能而不感到恶心或恶心，他们关心他们的生活。 晚上睡觉的能力。年轻人的父母也关心随后使用阿片类药物的风险， 与接受的治疗或随后使用剩余药丸有关，我们将客观地记录 使用PALGOR数据测量随后的阿片类药物处方。这项研究将是第一个解决这些问题的研究。 短轴 在我们建议的务实临床试验成功完成后，患者及其家属将更好地 能够就哪种止痛药（阿片类药物与非阿片类药物）最能控制其疼痛做出明智的决定。 牙科手术后疼痛，并将更好地了解与阿片类药物相关的潜在风险 处方

项目成果

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.

• DOI: 10.1186/s13063-022-06064-8
• 发表时间: 2022-02-17
• 期刊: Trials
• 影响因子: 2.5
• 作者: Feldman CA;Fredericks-Younger J;Lu SE;Desjardins PJ;Malmstrom H;Miloro M;Warburton G;Ward B;Ziccardi V;Fine D
• 通讯作者: Fine D

The Opioid Analgesic Reduction Study (OARS) Pilot: A Double-Blind Randomized Multicenter Trial.

阿片类镇痛药减量研究 (OARS) 试点：双盲随机多中心试验。

• DOI: 10.1177/23800844221144031
• 发表时间: 2024
• 期刊: JDR clinical and translational research
• 作者: Feldman,CA;Fredericks-Younger,J;Desjardins,PJ;Malmstrom,H;Miloro,M;Warburton,G;Ward,B;Ziccardi,V;Fine,DH;Greenberg,P;Andrews,T;Matheson,PB;Lu,S-E
• 通讯作者: Lu,S-E