NCT03365622

Efficacy of IV Acetaminophen Versus Oral Acetaminophen

Randomized, Double-Blind Clinical Study Evaluating Efficacy of Intravenous Versus Enteric Acetaminophen in Donor Nephrectomy and Robot-Assisted, Laparoscopic Nephrectomy.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 214 (actual)
• Sponsor: University of Rochester · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Nephrectomy

Interventions

Type	Name	Description
DRUG	acetaminophen	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.
DRUG	Acetaminophen	500mg acetaminophen tablet ,2 capsules oral every six hours for 24 hours
DRUG	Placebos	Placebo Intravenous doses will consist of 100ml of normal saline transferred to an empty sterile IV bag.
DRUG	Placebo Oral Tablet	Placebo, opaque capsules that have been filled with inert powder (lactose USP), 2 capsules oral every six hours for 24 hours

Timeline

• Start date: 2018-08-08
• Primary completion: 2024-04-10
• Completion: 2024-04-10
• First posted: 2017-12-07
• Last updated: 2025-06-29
• Results posted: 2025-06-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study