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Chronic Sinusitis | Intraoperative and Post-operative Analgesic Effect of IV Acetaminophen for Sinus Surgery

Chronic Sinusitis research study

What is the primary objective of this study?

The purpose of this study is to assess the use of IV acetaminophen (Ofirmev) as a and safe and efficacious agent in reducing post-operative pain; we hypothesize that its use will reduce post-operative pain when compared to a control group using the visual analogue score (VAS) analog pain scoring system.

Who is eligible to participate?

Inclusion criteria: 1. Patients undergoing surgical management for CRS (with or without polyps) 2. Operating time must be at least 2 hours in duration. 3. Number of sinuses involved must be 3 or greater Exclusion criteria: 1. History of hypersensitivity to acetaminophen 2. End stage renal disease 3. End stage liver disease 4. History of chronic pain, or use of opioid medication in the previous two weeks 5. Severe depression or anxiety 6. Use of gabapentin or any other pain modulator 7. History of acute sinusitis or mucocele 8. History of seizures 9. Known or suspected history of alcohol or drug abuse 10. Known or suspected history of morphine intolerance

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

Chronic Sinusitis

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:IV Acetaminophen1000mg IV acetaminophen over 15 minutes every 4 hours for up to 2 doses.

Drug:Placebo100 mL of 0.9% normal saline over 15 minutes in place of IV acetaminophen.

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.

IV AcetaminophenThe experimental group will receive a preoperative dose of 1000mg IV acetaminophen over 15 minutes. This will occur at least 15 minutes before the start of surgery. Another 1000mg dose of IV acetaminophen will be administered 4 hours after the first dose. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).

ControlThe control group (Placebo) will receive 100 mL of 0.9% normal saline in place of IV acetaminophen in the same manner as the experimental group; the investigator/physician in question will be blinded to the agent that is being administered. Patients will be discharged with instruction to continue APAP 500 mg PO every 6-8 hours. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).

Study Status

Completed

Start Date: July 2012

Completed Date: September 2014

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Pain Level Assessed Using a Visual Analogue Scale (VAS) Scale

Secondary Outcome: Total Doses of Postoperative Opiate (Morphine) Use

Study sponsors, principal investigator, and references

Principal Investigator: Davide Cattano, MD, PhD

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

Collaborator: Mallinckrodt

More information:https://clinicaltrials.gov/show/NCT01608308

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