Naproxen for Acute Pain After Surgery: A Randomized, Placebo-Controlled Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- cumulative opiate dose administered, as recorded on the computerized medication administration record (CMAR)
研究概览
简要总结
The purpose of this study is to determine whether using an additional 48 hours of oral naproxen, after other post-operative pain medications have been stopped, will be effective in reducing opiate pain medication requirements and contribute to improved pain management.
详细描述
At St. Joseph's Healthcare Hamilton, the Acute Pain Service (APS) is responsible for the immediate post-operative pain management of many surgical inpatients. While cared for by APS, the patient receives multimodal analgesia, including adjunctive medications (acetaminophen and naproxen/ketorolac) scheduled around the clock. When APS discontinues the epidural/pain pump, all adjunctive medications are discontinued and the patient is usually started on 'as needed' opiate or combination opiate (i.e. Tylenol#3) medications. On occasion, APS will write an order for an additional 48 hours of naproxen, but this practice has not been formally evaluated at this site. This randomized, placebo-controlled study proposes to evaluate this bridging strategy to see if regularly scheduled naproxen after discontinuation of other post-operative medications will affect the daily doses of opiate pain medications used, side effects of those opiate medications and pain scores of patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •undergone Head & Neck and Thoracic surgery
- •admitted to Chest, Head and Neck or Step-Down at St. Joseph's Healthcare
- •pain management by APS (epidural/pain pump) including naproxen/ketorolac
- •able to take oral medications (by mouth, feeding tube or NG tube)
- •reasonably able to communicate in English and provide consent
排除标准
- •pre-existing chronic pain (morphine equivalent doses over 200mg/day in 5 days previous to surgery)
- •recovering from cardiac, urological, orthopedic, laparoscopic or ambulatory surgery
- •chronic NSAID therapy (daily for more than 3 weeks or high dose (over 81mg) ASA at least 4 days/week for more than 3 weeks)
- •pregnancy, diagnosis of sepsis, history of stroke or transient ischemic attack, CHF (NYHA 3 or 4), allergy or contraindication to NSAIDS as defined by APS protocol
研究组 & 干预措施
A
干预措施: naproxen (Drug)
P
干预措施: placebo (Drug)
结局指标
主要结局
cumulative opiate dose administered, as recorded on the computerized medication administration record (CMAR)
时间窗: daily
次要结局
- patient reported pain scores(at least three times daily)
- side effects of study medication and opiate analgesia(at least three times daily)