Intravenous Acetaminophen for Craniotomy Patients (IVAC)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
|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|
- Total narcotic dose administered over the first 12 hours of postoperative recovery. [ Time Frame: 12 hours ] [ Designated as safety issue: No ]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.
- Incidence of nausea during postoperative recovery [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
- Incidence of vomiting during postoperative recovery [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
- Severity of nausea during postoperative recovery [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
- Severity of vomiting during postoperative recovery [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
|Study Start Date:||November 2011|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Active Comparator: Acetaminophen
Craniotomy patients will receive a 1000 mg dose of intravenous (IV) acetaminophen before incision and a second 1000 mg dose of IV acetaminophen 6 hours later.
1000 mg dose intravenous acetaminophen before craniotomy incision and a second 1000 mg dose intravenous acetaminophen 6 hours after surgery
No Intervention: No acetaminophen
Patients will receive standard of care with no intraoperative doses of acetaminophen.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01474304
|Contact: Becky Woodemail@example.com|
|Contact: Nathan Hansenfirstname.lastname@example.org|
|United States, Washington|
|Swedish Medical Center Cherry Hill Campus||Recruiting|
|Seattle, Washington, United States, 98122|
|Principal Investigator:||Arthur Lam, MD, FRCPC||Swedish Medical Center|