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Postoperative Pain | Intravenous Acetaminophen in Craniotomy

Postoperative Pain research study

What is the primary objective of this study?

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

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Postoperative Pain

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:AcetaminophenIntravenous Acetaminophen, 1000 mg/100mL, Every 6 hours, Infused over 15 minutes.

Drug:Placebo100 mL 0.9% Sodium Chloride

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Intravenous AcetaminophenPatients will be receive doses of 1000 mg/100 mL of IV Acetaminophen (OFIRMEV). The drug will be infused over 15 minutes.

PlaceboPatients will be given 100 mL normal saline placebos at scheduled time intervals in place of IV acetaminophen.

Study Status

Completed

Start Date: May 2, 2012

Completed Date: March 30, 2016

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Post-Operative Opioid Requirement

Secondary Outcome: Post-Operative Pain

Study sponsors, principal investigator, and references

Principal Investigator: Carlos A. Artime, MD

Lead Sponsor: The University of Texas Health Science Center, Houston

Collaborator: Mallinckrodt

More information:https://clinicaltrials.gov/show/NCT01598701

Artime CA, Aijazi H, Zhang H, Syed T, Cai C, Gumbert SD, Ferrario L, Normand KC, Williams GW, Hagberg CA. Scheduled Intravenous Acetaminophen Improves Patient Satisfaction With Postcraniotomy Pain Management: A Prospective, Randomized, Placebo-controlled, Double-blind Study. J Neurosurg Anesthesiol. 2018 Jul;30(3):231-236. doi: 10.1097/ANA.0000000000000461.

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