Prescribing Vs. Recommending Over-The-Counter (PROTECT) Analgesics for Patients with Postoperative Pain: a Project on Non-Opioid Pain Medication Use After Discharge from Elective Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Patient use of NSAIDS within 3 days after discharge from surgery
研究概览
简要总结
This is a research project in which two standard of care practices will be evaluated to examine the difference in outcomes. The goal is to improve patient care and safety. One group will receive prescriptions for acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), and magnesium. The other group will receive the recommendation to take acetaminophen, NSAIDs, and magnesium as over-the-counter drugs in the same dosage as the prescription group. The same doses and routes for non-opioid medications will be used in both groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Anticipated to be prescribed and use an opioid medication to treat acute pain after elective outpatient surgery
排除标准
- •Contraindications to taking acetaminophen or NSAIDs
- •Significant analgesic medication use before surgery
- •Inability to receive emails or phone calls for follow up assessment
- •Patients who have reoperation, another surgery, or experience complications within 14 days after surgery
研究组 & 干预措施
Prescription Group for acetaminophen, NSAIDs, and magnesium
Participants will receive prescriptions from the surgical team for non-opioid pain medications to take at home after discharge from surgery.
The non-opioid pain medications will be acetaminophen 1000 milligram (mg) four times a day (qid) for 3 days then as needed (prn) pain, ibuprofen 600 mg qid for 3 days then prn, and magnesium oxide 400 mg daily prn pain.
干预措施: Prescription by surgical team (Other)
Over the Counter Group
Participants will receive a recommendation from the surgical team to take over-the-counter non-opioid pain medications at home after discharge from surgery.
The non-opioid pain medications will be acetaminophen 1000 mg qid for 3 days then prn pain, ibuprofen 600 mg qid for 3 days then prn, and magnesium oxide 400 mg daily prn pain.
干预措施: Recommendation by surgical team (Other)
结局指标
主要结局
Patient use of NSAIDS within 3 days after discharge from surgery
时间窗: 3 days following surgery discharge
Patient-reported use of NSAIDs at any point in time within the first 3 days at home after discharge from surgery.
Patient use of acetaminophen within 3 days after discharge from surgery
时间窗: 3 days following surgery discharge
Patient-reported use of acetaminophen at any point in time within the first 3 days at home after discharge from surgery.
Maximal consumption of acetaminophen and NSAIDs within 3 days after discharge from surgery
时间窗: 3 days following surgery discharge
Patient report of the number of doses within the first 3 days of the use of both acetaminophen and NSAID at home after discharge from surgery. Patients are anticipated to take up to 4 doses of acetaminophen and NSAIDs per day. Over 3 days, patients would be anticipated to take a maximum of 12 doses. This outcome is a count that ranges from 0 (no doses of acetaminophen plus NSAIDs) to 12.
Patient use of acetaminophen and NSAID with opioid within 3 days after discharge from surgery
时间窗: 3 days following surgery discharge
Patient-reported use of both acetaminophen and NSAID on every day oral pain medication is taken within the first 3 days at home after discharge from surgery.
Delayed acetaminophen and NSAID use as reported at 12-16 days after discharge from surgery
时间窗: 12-16 days following surgery discharge
Patient-reported use of acetaminophen and/or NSAIDs in the second week after discharge from surgery.
次要结局
- Patient-reported consumption of opioid pills as reported at 12-16 days after discharge from surgery(12-16 days following surgery discharge)
- Pain intensity at site of surgery as reported at 12-16 days following surgery discharge(3 days following surgery discharge)
- Medication side effects within 3 days following surgery discharge(3 days following surgery discharge)
- Patient satisfaction with pain treatment within 3 days following surgery discharge(3 days following surgery discharge)
- Patient-reported consumption of opioid pills within 3 days after discharge from surgery(3 days following surgery discharge)
- Pain intensity at site of surgery 3 days following surgery discharge(3 days following surgery discharge)
- Patient use of magnesium within 3 days after discharge from surgery(3 days following surgery discharge)
- Delayed magnesium use days as reported at 12-16 days after discharge from surgery(12-16 days following surgery discharge)
研究者
Mark Bicket, MD, PhD
Assistant Professor
University of Michigan