Recruiting
Phase 3

Acetaminophen

Sponsor:

Massachusetts Eye and Ear Infirmary

Code:

NCT03295214

Conditions

Acetaminophen

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Acetaminophen

Study Details

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 the VAS for PO or IV acetaminophen. It is expected that in doing so the investigators can produce the maximal amount of pain relief after surgery while making conscientious monetary decisions.

Conditions

Acetaminophen

Study ID

NCT03295214

Start date

Mar 28, 2018

Status verified date

Apr, 2019

Completion date

Mar, 2020

Anticipated

Primary completion date

Mar, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

124 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

active comparator: Acetaminophen 975mg Per Os

975mg of Acetaminophen given by mouth

active comparator: Acetaminophen 1000mg Intravenous

1000mg of Acetaminophen given intravenously

Interventions

Acetaminophen

Acetaminophen given for pain relief

Primary outcome measure

  • VAS for pain [ Time Frame: 0-1 hour ]

Central Contacts and Locations

Central contacts

Amy Quinkert, PhD

6175734192amy_quinkert@meei.harvard.edu

Iuliu Fat, MD

617-573-3380iuliu_fat@meei.harvard.edu

Locations

Massachusetts Eye and Ear

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Brendan McBrine, BS

617-573-6815brendan_mcbrine@meei.harvard.edu

More Information

Sponsor

Massachusetts Eye and Ear Infirmary

Last update posted

Apr 10, 2019

Last verified

Apr, 2019

Keywords

  • Acetaminophen
  • Functional Endoscopic Sinus Surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts Eye and Ear Infirmary on 2019-04-10.