Phase 4
N=214
Efficacy of IV Acetaminophen Versus Oral Acetaminophen
Nephrectomy
Bottom Line
View on ClinicalTrials.gov: NCT03365622 ↗Enrolled (actual)
214
Serious AEs
0.9%
Results posted
Jun 2025
Primary outcome: Primary: Total Opioid Dose (MME) Used in 24 Hours — 103.61; 109.17 total morphine milligram equivalents — p=0.3938
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- acetaminophen (Drug); Placebos (Drug); Placebo Oral Tablet (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Rochester
- Primary completion
- Apr 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Opioid Dose (MME) Used in 24 Hours |
103.61; 109.17 | 0.3938 |
| SECONDARY Average Surgical Pain Intensity |
4.46; 4.77 | 0.3852 |
| SECONDARY Average Surgical Pain Intensity |
4.46; 4.77 | 0.3852 |
| SECONDARY Mean Inspiratory Capacity |
64.41; 63.35 | 0.5839 |
| SECONDARY Mean Inspiratory Capacity |
64.41; 63.35 | 0.5839 |
| SECONDARY Dynamic Pain Score During Incentive Spirometer Use |
4.62; 5.12 | 0.1502 |
| SECONDARY Dynamic Pain Score During Incentive Spirometer Use |
4.62; 5.12 | 0.1502 |
| SECONDARY Surgical Pain Score During the 20-24 Hour Assessment |
3.52; 3.89 | 0.2797 |
| SECONDARY Time to First Narcotic Use |
3.31; 2.85 | 0.6527 |
| SECONDARY Number of Participants With Nausea |
58; 40 | 0.0499 sig |
| SECONDARY Time to Discharge From Post-anesthesia Care Unit |
174.17; 195.48 | 0.179 |
| SECONDARY Time to Hospital Discharge |
2.33; 2.60 | 0.2811 |
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.
Eligibility Criteria
Inclusion Criteria
- Be at least 18 years old
- Be scheduled for donor nephrectomy or robot-assisted, laparoscopic nephrectomy for cancer at University of Rochester Medical Center
- Have cognitive ability to verbally rate their pain on the Numeric Rating Scale (NRS).
Exclusion Criteria
- Age younger than 18 years old or older than 90 years old
- Pregnancy (Pre-operative pregnancy test is standard of care for all elective operating room cases)
- Weight less than 50 kg
- Epidural use
- History of known liver disease.
- Patient unable to take enteral medications.
- Be taking opioid medications chronically.
Data sourced from ClinicalTrials.gov (NCT03365622). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.