Intravenous Acetaminophen for Craniotomy Patients
Information source: Swedish Medical Center
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Craniotomy
Intervention: Acetaminophen (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Swedish Medical Center Official(s) and/or principal investigator(s): Arthur Lam, MD, FRCPC, Principal Investigator, Affiliation: Swedish Medical Center
Overall contact: Becky Wood, Phone: 206-320-7115, Email: becky.wood@swedish.org
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.
Clinical Details
Official title: Intravenous Acetaminophen for Craniotomy Patients: A Single-blinded, Randomized Controlled Trial to Evaluate the Effect of Intravenous Acetaminophen Administered at Induction and Emergence From Craniotomy
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care
Primary outcome: Total narcotic dose administered over the first 12 hours of postoperative recovery.
Secondary outcome: Incidence of nausea during postoperative recoveryIncidence of vomiting during postoperative recovery Severity of nausea during postoperative recovery Severity of vomiting during postoperative recovery
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Becky Wood, Phone: 206-320-7115, Email: becky.wood@swedish.org
Swedish Medical Center Cherry Hill Campus, Seattle, Washington 98122, United States; Recruiting
Additional Information
Starting date: November 2011
Last updated: June 4, 2015
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