Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
214 participants
INTERVENTIONAL
2018-08-08
2024-04-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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IV acetaminophen and placebo pills
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.
Placebo Oral Tablet
Placebo, opaque capsules that have been filled with inert powder (lactose USP), 2 capsules oral every six hours for 24 hours
placebo IV (normal saline) + oral acetaminophen
Acetaminophen
500mg acetaminophen tablet ,2 capsules oral every six hours for 24 hours
Placebos
Placebo Intravenous doses will consist of 100ml of normal saline transferred to an empty sterile IV bag.
Interventions
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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.
Acetaminophen
500mg acetaminophen tablet ,2 capsules oral every six hours for 24 hours
Placebos
Placebo Intravenous doses will consist of 100ml of normal saline transferred to an empty sterile IV bag.
Placebo Oral Tablet
Placebo, opaque capsules that have been filled with inert powder (lactose USP), 2 capsules oral every six hours for 24 hours
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
89 Years
ALL
No
Sponsors
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University of Rochester
OTHER
Responsible Party
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Joseph W Dooley, MD
Associate Professor
Locations
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University of Rochester Medical Center
Rochester, New York, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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70162
Identifier Type: -
Identifier Source: org_study_id
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