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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 Requirement

Post-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

Page last updated: August 23, 2015

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