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: 10227266
• 负责人: Cecile Feldman
• 金额: $ 312.75万
• 依托单位: RBHS-SCHOOL OF DENTAL MEDICINE
• 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/10227266
• 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 Background; Emergency Situation; Ethnic Origin; Euphoria; Exhibits; Exposure to; Family; Feeling; Female; Frequencies; Future; Gender; Guidelines; Habits; Headache; Health Personnel; Health Professional; Hour; Household; Hydrocodone; Hydrocodone/Acetaminophen; Ibuprofen; Lightheadedness; Location; Mandible; Maxilla; Measures; Medical; Methods; Modeling; Monitor; Nausea; Operative Surgical Procedures; Opioid; Opioid Analgesics; Outcome; Pain; Pain Threshold; Pain management; Parents; Patient risk; Patients; Pattern; Polysomnography; Postoperative Pain; Postoperative Period; Pragmatic clinical trial; Pruritus; Race; Randomized; Randomized Clinical Trials; Reporting; Risk; School-Age Population; Serious Adverse Event; Severities; Site; Sleep; Tablets; Testing; Time; United States; Urinary Retention; Visit; Vomiting; Writing; addiction; base; 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; 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.

项目摘要/摘要 每天，人们都会不必要地死于与阿片类药物过量相关的成瘾。每一张阿片类药物处方 患者滥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，每年拔除第三颗磨牙后，350万年轻人可能会被 牙医不必要地接触阿片类药物，增加了患者成瘾的风险。 为包括牙医在内的卫生保健专业人员和他们的病人提供尽可能好的证据 对于基于临床的决策，当决定用于手术后急性疼痛处理的镇痛剂时， 我们提出了一项双盲、分层随机临床试验，以证明非处方药与非处方药的组合 含有非阿片类止痛药的镇痛剂并不比最常用的处方阿片类止痛药差。 患者将在每个研究地点/诊所内随机分组，并根据性别进行分层，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 可预测的术后疼痛严重程度和结果的概括性。在每个站点/诊所内 性别类型(男性/女性)，患者将随机接受任何一种阿片类药物 (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、睡眠能力和执行日常功能的能力。至 开发临床指南和临床决策工具，包括疼痛管理、拔牙困难和 将收集服用的药片数量，以便开发一种实验性的决策工具。 所提出的方法弥补了其他止痛药研究的不足。尽管之前的研究已经 测试单剂止痛药的短期效果，患者和他们的牙医感兴趣 管理整个手术后的急性疼痛，而不仅仅是最初的12个小时。他们关心他们的 能够执行正常的日常功能，而不会感到恶心或恶心，他们关心自己的 夜间入睡的能力。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的剩余药丸有关，我们将客观地捕获这些信息 使用PDMP数据衡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 缺点。 在我们建议的务实临床试验成功完成后，患者及其家属将会更好 能够做出明智的决定，决定哪种止痛药(阿片类药物与非阿片类药物)将最好地管理他们的 牙科手术后的疼痛，并将更好地了解与阿片类药物相关的潜在风险 处方。