Postoperative Pain
Conditions
Keywords
acetaminophen, pain, laminectomy, craniotomy
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.
Interventions
DRUGAcetaminophen or Placebo
Study subject will receive either 1000mg of acetaminophen in 100ml own diluent, or 100ml of saline during their intra-operative period and an order will be placed in their chart/Essentris order for No acetaminophen for 6 hours post operatively.
Sponsors
Brooke Army Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
Primary ContactDimitar Dentchev, MD
Outcome results
None listed