Intravenous Acetaminophen in Craniotomy

• Status: Completed
• Trial end date: 2016-03-30
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Health Science Center, Houston
• Collaborator: Mallinckrodt
• Treatments: Acetaminophen

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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