Prospective Randomized Control Trial Assessing Effects of Pre-Operative Acetaminophen in Isolated Meniscectomy Patients
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Pain using the visual analogue scale
研究概览
简要总结
Patients that are to undergo isolated meniscectomy will be randomized to 2 cohorts: one will take the FDA recommended dose of acetominophen (1000mg) 24hrs before surgery, one will be given a similarly looking placebo pill. A multitude of post-op variables will be included, mainly pain scores and morphine equivalent doses at different time points.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be at least 18 years of age
- •ASA Class I-II
- •Patients scheduled for meniscectomy
排除标准
- •Contraindication to acetaminophen (hypersensitivity, extensive alcohol history, liver disease, actively breastfeeding)
- •Legally incompetent or mentally impaired (e.g., minors, Alzheimer's subjects, dementia, etc.)
- •Younger than 18 years of age or older than 65
- •Any patient considered a vulnerable subject
- •Patients on pain medication prior to surgery
研究组 & 干预措施
1000 Mg Acetaminophen
Acetaminophen will be given 24 hours before surgery
干预措施: Acetaminophen (Drug)
Placebo
A sugar pill will be given 24 hours before the scheduled surgery.
干预措施: Placebo (Other)
结局指标
主要结局
Pain using the visual analogue scale
时间窗: 7 Days
The visual analogue scale is a scale with a line from 0 on one side and 100 on the other where the patient is asked to mark where they believe their pain is.
Narcotic Use
时间窗: 7 Days
Total morphine-equivalent dose consumption during immediate post-op, phase 1 recover, phase II recovery, at 2 days, and at 7 days will also be recorded.
Measure of time to discharge from the PACU
时间窗: 7 Days
Time to discharge from the PACU
Morphine-equivalent dose consumption
时间窗: 7 days
Total morphine-equivalent dose consumption during immediate post-op, phase 1 recover, phase II recovery, at 2 days, and at 7 days
Measure of time to discharge from hospital
时间窗: 7 Days
Time to discharge from the hospital
次要结局
未报告次要终点