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: 10452705
• 负责人: Cecile Feldman
• 金额: $ 296万
• 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/10452705
• 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; Persons; 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.

项目概要/摘要 每天都有人因阿片类药物过量相关的成瘾而不必要地死亡。 估计服用 5600 万片 5 毫克氢可酮，患者误用或滥用阿片类药物的风险就会增加。 在美国，每年有 350 万年轻人在拔除第三磨牙后服用 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 在决定用于急性术后疼痛管理的镇痛药时用于基于临床的决策， 我们提出了一项双盲、分层随机临床试验来证明非处方药的组合 不含阿片类药物的镇痛药并不比最常用的阿片类药物镇痛药差。 患者将在每个研究中心/诊所内进行随机分配，并根据性别进行分层 由于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每个站点/诊所内结果的普遍性。 性别类型（男性/女性），患者将被随机分配接受阿片类药物治疗 （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。 制定临床指南和临床决策工具、疼痛管理、拔牙难度和 将收集服用的药片数量，以便开发实验决策工具。 尽管先前的研究已经提出，但所提出的方法解决了其他镇痛研究的缺点。 测试了单剂量止痛药的短期效果，患者及其牙医对此感兴趣 控制整个术后期间的急性疼痛，而不仅仅是前 12 小时。 能够执行正常的日常功能而不会感到恶心或恶心，并且他们关心自己的 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，我们将客观地捕获 这项研究将是第一个解决这些问题的研究。 缺点。 成功完成我们提出的务实临床试验后，患者及其家人将会得到更好的治疗 能够就哪种止痛药（阿片类药物与非阿片类药物）最能控制他们的症状做出明智的决定 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。