Use of IV Acetaminophen in the Treatment of Post Operative Pain in Patients Undergoing Craniotomy and Spine Surgery
- Registration Number
- NCT03261310
- Lead Sponsor
- Brooke Army Medical Center
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 55
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Acetaminophen & Laminectomy Acetaminophen or Placebo Acetaminophen 1000mg administered intravenously during laminectomy. Placebo & Laminectomy Acetaminophen or Placebo Placebo administered during laminectomy. Acetaminophen & Craniotomy Acetaminophen or Placebo Drug: Acetaminophen 1000mg administered intravenously during craniotomy Placebo & Craniotomy Acetaminophen or Placebo Placebo administered intravenously during craniotomy.
- Primary Outcome Measures
Name Time Method Pain Scores 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).
- Secondary Outcome Measures
Name Time Method Opioid administration 1 hour-6 hours Secondary outcome will be a comparison of morphine equivalent dosages of opioid administered during the same periods between the treatment and control groups.
Trial Locations
- Locations (1)
Brooke Army Medical Center
🇺🇸San Antonio, Texas, United States