Intravenous Acetaminophen in Craniotomy

Completed · Phase 4 · Has a placebo group

Conditions studied: Postoperative Pain

In brief

The purpose of this study is to assess the use of intravenous Acetaminophen (OFIRMEV) as an effective adjunct therapeutic agent in patients undergoing craniotomy.

Key facts

Study ID

NCT01598701

Run by

The University of Texas Health Science Center, Houston

People needed

100

Starts

2012-05-02

Expected to finish

2016-03-30

Last updated by the study team

2018-06-19

Who can join

Age: 18 and older, up to 120. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults
• 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

You may not qualify if…

• 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.
• Uncontrolled Hypertension

Where it is running

• Memorial Hermann Hospital - Texas Medical Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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