Use of IV Acetaminophen in the Treatment of Post Operative Pain in Patients Undergoing Craniotomy and Spine Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Pain Scores
研究概览
简要总结
The purpose of this study is to investigate the effectiveness of intravenous acetaminophen (Tylenol) for post operative pain control in patients undergoing craniotomies (brain surgery) and spine surgery. Studies have shown that intravenous acetaminophen is useful for post operative pain control in some operations but there have not been studies to evaluate the use of acetaminophen in craniotomies or spine surgery.
详细描述
The purpose of this study is to investigate the effectiveness of intravenous acetaminophen (Tylenol) for post operative pain control in patients undergoing craniotomies (brain surgery) and spine surgery. Studies have shown that intravenous acetaminophen is useful for post operative pain control in some operations but there have not been studies to evaluate the use of acetaminophen in craniotomies or spine surgery.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-90 years old
- •undergoing non-emergent craniotomy or single level lumbar laminectomy
- •must be able to rate pain on a 0-10 scale post-operatively
排除标准
- •history of liver disease
- •allergy to acetaminophen
- •age less than 18 years
- •renal failure with creatinine clearance less than 30
- •pregnancy
- •altered mentation with inability to report pain score
- •patients who have received acetaminophen within 6 hours of surgery
- •patients in which a neuraxial technique has been performed for surgery
- •prisoners
研究组 & 干预措施
Acetaminophen & Craniotomy
Drug: Acetaminophen 1000mg administered intravenously during craniotomy
干预措施: Acetaminophen or Placebo (Drug)
Placebo & Craniotomy
Placebo administered intravenously during craniotomy.
干预措施: Acetaminophen or Placebo (Drug)
Acetaminophen & Laminectomy
Acetaminophen 1000mg administered intravenously during laminectomy.
干预措施: Acetaminophen or Placebo (Drug)
Placebo & Laminectomy
Placebo administered during laminectomy.
干预措施: Acetaminophen or Placebo (Drug)
结局指标
主要结局
Pain Scores
时间窗: 1hour -6 hours
Primary outcomes will be measured pain scores at post-operative timepoints (1, 2, 4 and 6 hours), and the calculated percent change from baseline (1 hr post-op) for each of the follow-up pain scores (2, 4, 6 hours).
次要结局
- Opioid administration(1 hour-6 hours)
研究者
Dimitar Dentchev
Staff Anesthesiologist
Brooke Army Medical Center