Status:
UNKNOWN
Intravenous Acetaminophen for Craniotomy Patients
Lead Sponsor:
Swedish Medical Center
Collaborating Sponsors:
Mallinckrodt
Conditions:
Craniotomy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Adding intraoperative IV acetaminophen, in addition to standard analgesics, will decrease opioid requirements over the first 12 hours of postoperative recovery following craniotomy. Opioids exacerbate...
Eligibility Criteria
Inclusion
- At least 18 years of age
- Weigh at least 50 kg (110.23 lbs)
- Undergoing open, elective intracranial procedure for
- tumor resection
- aneurysm clipping
- revascularization
- Have an ASA (American Society of Anesthesiologists) physical status of 1, 2, 3, or 4
- Able to provide written informed consent
Exclusion
- Significant medical disease, laboratory abnormality, or condition that, in the opinion of the investigator, would compromise patient welfare or would otherwise contraindicate study participation
- Unable to communicate symptoms
- Current daily opioid use (\>40 mg morphine equivalent)
- Tramadol use
- Treated with MAO (monoamine oxidase inhibitors) inhibitors within 10 days of surgery
- Treated with any amount of acetaminophen within 8 hours of anesthesia for surgery
- Allergic or hypersensitive to acetaminophen or any contraindications per manufacturer's guidelines
- Pregnancy
- Impaired liver function
- Participation in interventional clinical study within the last 30 days
- Known or suspected history of alcohol or drug abuse
- Surgery for resection of acoustic neuroma
- Transphenoidal tumor resection
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01474304
Start Date
November 1 2011
Last Update
September 29 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Swedish Medical Center Cherry Hill Campus
Seattle, Washington, United States, 98122