Opioid Analgesic Reduction Study (OARS) - Pilot
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 5
- 主要终点
- Pain Level
研究概览
简要总结
The purpose of this study is to test protocols being developed for the conduct of a large sale multi-site clinical trial which will compare opioids to non-opioids for managing post-surgical impacted 3rd molar extraction pain.
详细描述
A double-blind stratified randomized clinical trial is being conduct on the management of post-surgical pain after extraction of impacted third mandibular molars Subjects will be randomly assigned to either the OPIOID or NON-OPIOID group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Analgesic is formulate in capsules. Both OPIOID and NON-OPIOID analgesic formulas are packaged in the same capsules
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult men and non-pregnant women who are at least 18 years of age, who are able to refrain from driving or operating heavy machinery while taking the study medication will be able to participate.
- •Subjects who are English speaking and are able to provide consent will be considered.
- •Subjects must be in generally good health and able to take ibuprofen, paracetamol (acetaminophen), and hydrocodone.
排除标准
- •Subjects who self-report the following history will be excluded from participating:
- •Individual under the age of 18
- •History of gastrointestinal bleeding and/or peptic ulcer
- •History of renal disease (excluding kidney stones)
- •History of hepatic disease
- •History of bleeding disorder
- •History of respiratory depression
- •Any prior respiratory effect of an opioid or other anesthetic drug that required respiratory support postoperatively
- •Active or untreated asthma
- •History of known allergic reaction to ibuprofen, acetaminophen, hydrocodone, and/or anesthesia
- •Currently taking any of the following medications:
- •CYP3A4 inhibitor, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), and protease inhibitors (e.g., ritonavir), which may increase plasma concentrations of hydrocodone bitartrate and acetaminophen and prolong opioid adverse reactions, and which may cause potentially fatal respiratory depression
- •CNS depressants.
- •Consumes 3 or more alcoholic drinks every day and/or has a history of alcoholism
- •History of drug or alcohol abuse (excludes marijuana use)
- •Family history of drug or alcohol abuse in a first degree relative
- •Has had one or more opioid prescription filled within the past 6 months
- •Currently pregnant or lactating
- •Patients would also be excluded due to any additional criteria that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study which includes:
- •Prior participation in this study
- •Inability or refusal to provide informed consent
研究组 & 干预措施
Non-Opioid
Combination analgesic of ibuprofen 400mgacademinophen 350mg
干预措施: NON-OPIOID (Drug)
Opioid
Combination analgesic of hydrocodone 5mg/acetaminophen350 mg
干预措施: OPIOID (Drug)
结局指标
主要结局
Pain Level
时间窗: Average for the first seven days post surgery
Pain (self reported by subject) rated on numeric rating scale (0=no pain, 10=worst pain
次要结局
- Sleep Quality(Average for the first seven nights post surgery)
- Pain Interference Scale (Patient Report Outcomes Measurement Information System - PROMIS 6b )(Average for the first seven days post surgery)
- Overall Satisfaction(Average for the first seven days post surgery)
研究者
Cecile A. Feldman, DMD
Professor and Dean, Rutgers School of dental Medicine
Rutgers, The State University of New Jersey