Status:

UNKNOWN

Acetaminophen Given Per Os and Intravenous in Sinus Surgery

Lead Sponsor:

Massachusetts Eye and Ear Infirmary

Conditions:

Acetaminophen

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief Summary

The primary objective of this study is to investigate the Visual Analog Score (VAS) for pain within the post-operative setting and determine if there is a statistically significant difference between ...

Detailed Description

Functional Endoscopic Sinus Surgery (FESS) is one of the most common Ear Nose and Throat Surgeries done in the United States annually. This procedure can vary from intense to moderate pain and as such...

Eligibility Criteria

Inclusion

  • Willingness to participate
  • Undergoing FESS surgery at Massachusetts Eye and Ear (MEE)
  • Over the age of 18 during time of surgery
  • Weighing over 50kg

Exclusion

  • Severe hepatic impairment or active liver disease
  • Known hypersensitivity to acetaminophen or to any excipients in the intravenous formulation
  • chronic opioid use
  • chronic pain
  • alcohol or drug abuse

Key Trial Info

Start Date :

March 28 2018

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

March 1 2020

Estimated Enrollment :

124 Patients enrolled

Trial Details

Trial ID

NCT03295214

Start Date

March 28 2018

End Date

March 1 2020

Last Update

April 10 2019

Active Locations (1)

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Massachusetts Eye and Ear

Boston, Massachusetts, United States, 02114