Efficacy of IV Acetaminophen Versus Oral Acetaminophen

University of Rochester

Status and phase: Completed; Phase 4

Conditions: Nephrectomy

Treatments: Drug: acetaminophen; Drug: Acetaminophen; Drug: Placebo Oral Tablet; Drug: Placebos

Study type: Interventional

Funder types: Other

Identifiers

NCT03365622

70162

Details and patient eligibility

About

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.

Enrollment: 214 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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214 participants in 2 patient groups, including a placebo group

IV acetaminophen and placebo pills

Active Comparator group

Treatment:

Drug: Placebo Oral Tablet

Drug: acetaminophen

placebo IV (normal saline) + oral acetaminophen

Placebo Comparator group

Treatment:

Drug: Placebos

Drug: Acetaminophen