At a glance
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Randomized, Double-Blind Clinical Study Evaluating Efficacy of Intravenous Versus Enteric Acetaminophen in Donor Nephrectomy and Robot-Assisted, Laparoscopic Nephrectomy.
In Brief
A Phase 4 clinical trial evaluating acetaminophen, Acetaminophen, and 2 other interventions for Nephrectomy. Completed, enrolled 214 participants across 1 site.
Detailed Summary
The aim of this study is to determine whether intravenous acetaminophen compared to enteric acetaminophen offers increased efficacy in patients who are scheduled for laparoscopic donor nephrectomy and for patients scheduled for robot-assisted, laparoscopic nephrectomy for cancer at the University of Rochester Medical Center. The standard surgical and post-operative care, including post-operative pain management will not be altered.
Study Details
Timeline
Interventions
Active Intravenous doses will consist of a single 1,000mg/100 ml IV dose with contents of commercial vials transferred to an empty sterile IV bag.
500mg acetaminophen tablet ,2 capsules oral every six hours for 24 hours
Placebo Intravenous doses will consist of 100ml of normal saline transferred to an empty sterile IV bag.
Placebo, opaque capsules that have been filled with inert powder (lactose USP), 2 capsules oral every six hours for 24 hours