Craniotomy
Conditions
Keywords
craniotomy, tumor resection, aneurysm, revascularization, opioid, nausea, vomiting, acetaminophen
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 symptoms of nausea and vomiting. Reducing postoperative opioid use hopefully will reduce incidence of nausea and vomiting in patients after craniotomy.
Interventions
DRUGAcetaminophen
1000 mg dose intravenous acetaminophen before craniotomy incision and a second 1000 mg dose intravenous acetaminophen 6 hours after surgery
Sponsors
Mallinckrodt
Swedish Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total narcotic dose administered over the first 12 hours of postoperative recovery. | 12 hours | Intensive care nurses will ask subject about pain and nausea every 15 minutes for the first two hours immediately after surgery and then every hour afterward for up to 12 hours. Nurses will record subject response and opioid doses given. |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of nausea during postoperative recovery | 12 hours |
| Incidence of vomiting during postoperative recovery | 12 hours |
| Severity of nausea during postoperative recovery | 12 hours |
| Severity of vomiting during postoperative recovery | 12 hours |
Countries
United States
Contacts
Primary ContactBecky Wood
Backup ContactNathan Hansen
Outcome results
None listed