Acetaminophen Given Per Os and Intravenous in Sinus Surgery

Phase 3

• Conditions: Acetaminophen
• Interventions: Drug: Acetaminophen

• Registration Number: NCT03295214
• Lead Sponsor: Massachusetts Eye and Ear Infirmary

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.

Study Timeline

• Study First Submitted: 2017-09-21
• Study First Submitted QC: 2017-09-22
• Study First Posted: 2017-09-27
• Study Start: 2018-03-28
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-08
• Last Update Posted: 2019-04-10
• Primary Completion: 2020-03
• Study Completion: 2020-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 124

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acetaminophen 1000mg Intravenous	Acetaminophen	1000mg of Acetaminophen given intravenously
Acetaminophen 975mg Per Os	Acetaminophen	975mg of Acetaminophen given by mouth

Primary Outcome Measures

Name	Time	Method
VAS for pain	0-1 hour	First VAS pain score applied

Secondary Outcome Measures

Name	Time	Method
Opioid Use	24 hours	Postoperative opioid consumption for pain control
Time in PACU	3-5 hours	Time required to be admitted and discharged home
VAS for pain	24 hours	Last VAS pain score applied
PONV	24 hours	Incidence of PONV

Trial Locations

Locations (1)

Massachusetts Eye and Ear; 🇺🇸 Boston, Massachusetts, United States