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Acetaminophen Given Per Os and Intravenous in Sinus Surgery

A Prospective Clinical Trial Evaluating the Post-Operative Analgesic Effects of Acetaminophen Given Per Os and Intravenous

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03295214
Enrollment
124
Registered
2017-09-27
Start date
2018-03-28
Completion date
2020-03-31
Last updated
2019-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acetaminophen

Keywords

Acetaminophen, Functional Endoscopic Sinus Surgery

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.

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 it is difficult to properly gauge and treat postoperative pain in these patients. Commonly used in these cases, opioid drugs are given to provide adequate analgesia, however higher opioid usage is observed to cause increased Post-Anesthesia Care Unit (PACU) stays, respiratory complications and Postoperative Nausea and Vomiting (PONV). Acetaminophen is commonly used as an adjunct in these circumstances because of its opioid sparing properties. Acetaminophen is a synthetic nonopioid p-aminophenol derivative available over the counter. Its properties include analgesic and antipyretic qualities and it is listed on the world health organization's list of essential medicines. The potential risks include liver damage, skin reactions and drug interactions when used with blood thinners at high doses. Acetaminophen has been extensively researched, in vitro and in vivo studies have found the drug to be safe when used at proper doses. Recently intravenous use of acetaminophen has gained popularity due to ease of use and ability to be given intraoperatively. This form of acetaminophen, although convenient, is around sixty two times the cost of oral acetaminophen. Due to this increased cost it is imperative that the investigators compare the two routes of administration in order to determine if the additional cost is justified.

Interventions

DRUGAcetaminophen

Acetaminophen given for pain relief

Sponsors

Massachusetts Eye and Ear Infirmary
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
VAS for pain0-1 hourFirst VAS pain score applied

Secondary

MeasureTime frameDescription
Opioid Use24 hoursPostoperative opioid consumption for pain control
Time in PACU3-5 hoursTime required to be admitted and discharged home
VAS for pain1-2 hoursSecond VAS pain score applied
PONV24 hoursIncidence of PONV

Countries

United States

Contacts

Primary ContactAmy Quinkert, PhD
amy_quinkert@meei.harvard.edu6175734192
Backup ContactIuliu Fat, MD
iuliu_fat@meei.harvard.edu617-573-3380

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026