The Effect of Intravenous Acetaminophen on Post-Operative Pain After Craniotomy: A Randomized Control Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Stanford University
- Enrollment
- 27
- Locations
- 1
- Primary Endpoint
- Post-operative Opioid Consumption
Study Overview
Brief Summary
The purpose of the study is to determine the efficacy of IV acetaminophen when administered to neurosurgical patients at the beginning and end of their surgery. If the result is improved pain control with less opioid consumption postoperatively, then those patients may also experience less opioid related side effects such as nausea/vomiting, pruritus, and sedation. While numerous other studies have failed to show a benefit of IV acetaminophen after neurosurgical procedures, we are studying the administration of 1 g in two doses over the course of the operation.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with a diagnosis of bilateral moyamoya disease scheduled for bilateral external-carotid to internal-carotid bypass surgery to be done in two stages.
Exclusion Criteria
- •Allergy or history of reaction to acetaminophen. Patients with liver disease. Anyone not able to provide informed consent.
Arms & Interventions
Acetaminophen First
Patients in this group are presenting for 2 surgeries and will be administered intravenous acetaminophen in one surgery and placebo in the other. Patients in this group will be randomized to receive acetaminophen first.
Intervention: Acetaminophen (Drug)
Acetaminophen First
Patients in this group are presenting for 2 surgeries and will be administered intravenous acetaminophen in one surgery and placebo in the other. Patients in this group will be randomized to receive acetaminophen first.
Intervention: Placebo (Drug)
Placebo First
Patients in this group are presenting for 2 surgeries and will be administered intravenous acetaminophen in one surgery and placebo in the other. Patients in this group will be randomized to receive placebo first.
Intervention: Acetaminophen (Drug)
Placebo First
Patients in this group are presenting for 2 surgeries and will be administered intravenous acetaminophen in one surgery and placebo in the other. Patients in this group will be randomized to receive placebo first.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Post-operative Opioid Consumption
Time Frame: Up to 24 hours post-operative
From nursing records how much opioid was administered to each patient post-operatively. Opioid use was measured in micrograms (ug) of fentanyl.
Post-operative Pain
Time Frame: Up to 24 hours post-operative
Patients were asked to rate their pain on a scale of 1 to 10, with 1 being least pain, and 10 being most pain. Pain was assessed continually once per hour during the post-operative period and the average pain score calculated per participant. The average of the participants' average scores is presented for each group.
Secondary Outcomes
- Count of Participants Requiring Anti-emetic Administration(Up to 24 hours post-operative)
Investigators
Mark Burbridge
Principal Investigator
Stanford University