Clinical trial NCT03445390
Conditions: Pain
Sponsor: Stanford University
Start date: 2014-05-01; Completion date: 2017-11-01
Enrollment: 27 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

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.

Detailed description:

Arms: arm 1: 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. arm 2: 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.
Interventions: intervention 1: Acetaminophen intervention 2: Placebo
Intervention descriptions: intervention 1: Acetaminophen 1 g intravenous given at the beginning and end of surgery. intervention 2: Placebo to match acetaminophen given at the beginning and end of surgery.

Protocol documents:
Prot_000.pdf: 
The Effect of Intravenous Acetaminophen on Post-Operative Pain After 
Craniotomy (NCT03445390) 
May 29, 2013 
Mark Burbridge, MD, Principal Investigator 
Stanford University 
Stanford, California 94305 
 
Acetaminophen efficacy study protocol 
 
Brief protocol: 
 
Patients will be consented for the study on the day of their first surgery.   
 
Randomization will be coordinated with pharmacy.  Patient will be randomized by 
pharmacy to receive either acetaminophen or placebo at the end of the case, and 
then for the next 24 hours. 
 
Anesthesia will be induced with fentanyl, propofol, and rocuronium, administered at 
the discretion of the anesthesiologists.   
 
The anesthetic will be maintained with a combination of isoflurane, remifentanil, 
nitrous oxide, and/or propofol.   
 
The surgeons are free to infiltrate the incision with local anesthetic.   
 
At the end of the case while the patient is emerging from anesthesia, administer 1 
gram IV acetaminophen or placebo over 15 minutes.  Except for remifentanil, do not 
administer any other opioids at the end of the case.   
 
At arrival to the ICU, a patient controlled analgesia (PCA) pump will be setup and 
immediately made available to the patient.   
 
The ICU nurse will be informed of the study, and handed material that will explain 
their portion of the study, including assessments and drug administration.   
 
After 24 hours, the post-operative assessment form filled out by nursing will be 
collected.   
 
Within 30 days of discharge following the second surgery, the patients will be 
contacted via their method of choice to participate in a brief survey.