The purpose of this study is to assess the use of intravenous Acetaminophen (OFIRMEV) as an
effective adjunct therapeutic agent in patients undergoing craniotomy.
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Locations near you
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Full eligibility criteria for NCT01598701
Ages eligible for Study
18 Years to 120 Years
Genders eligible for Study
Accepts Healthy Volunteers
Undergoing Craniotomy for Supratentorial Tumor Resection
Weight between 50 and 120 kilograms
ASA Physical Status I-III
Be able to communicate verbally
Be able to use Visual Analog Score
Allergies to acetaminophen, morphine or any of the anesthetic agents required by the protocol.
Use of opioids, tramadol, benzodiazepines, or gabapentin on a daily basis for > 7 days prior to the day of surgery.
Use of acetaminophen, NSAIDs, or any other analgesic medication in the 12 hours immediately prior to study enrollment.
Hepatic insufficiency (elevated transaminases > 1.5 times the upper limit of normal) or renal insufficiency (plasma creatinine > 2mg/dl).
Known or suspected history of alcohol or illicit drug abuse.
Pregnant or breast-feeding.
Surgical plan for infratentorial (suboccipital) craniotomy.
Plan for neurophysiologic monitoring that precludes the use of neuromuscular blockade.
Inability to communicate due to a language barrier, impaired consciousness, cognitive defect or intellectual disability.
All locations for NCT01598701
United States (1)
Memorial Hermann Hospital - Texas Medical Center
Houston, Texas, United States, 77030
View full eligibility
Tris trial is registered with FDA with number: NCT01598701. The sponsor of the trial is The University of Texas Health Science Center, Houston and it is looking for 100 volunteers for the current phase.
Official trial title: The Opioid-Sparing and Analgesic Effects of IV Acetaminophen in Craniotomy: A Prospective, Randomized, Placebo-Controlled, Double-Blind Study
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