Intravenous Acetaminophen in Craniotomy
Information source: The University of Texas Health Science Center, Houston
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postoperative Pain
Intervention: Acetaminophen (Drug); Placebo (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: The University of Texas Health Science Center, Houston Official(s) and/or principal investigator(s): Carlos A. Artime, MD, Principal Investigator, Affiliation: University of Texas Health Sciences Center at Houston Sam D. Gumbert, MD, Principal Investigator, Affiliation: University of Texas Health Sciences Center at Houston Carin A. Hagberg, MD, Study Chair, Affiliation: University of Texas Health Sciences Center at Houston
Overall contact: Carlos A. Artime, MD, Phone: (713)500-6200, Email: Carlos.Artime@uth.tmc.edu
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.
Clinical Details
Official title: The Opioid-Sparing and Analgesic Effects of IV Acetaminophen in Craniotomy: A Prospective, Randomized, Placebo-Controlled, Double-Blind Study
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Primary outcome: Post-Operative Opioid Requirement
Secondary outcome: Intra-Operative Opioid RequirementPost-Operative Pain Post-Operative Side Effects
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Carlos A. Artime, MD, Phone: (713)500-6200, Email: Carlos.Artime@uth.tmc.edu
Memorial Hermann Hospital - Texas Medical Center, Houston, Texas 77030, United States; Recruiting
Additional Information
Starting date: June 2012
Last updated: July 29, 2015
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