Acetaminophen Given Per Os and Intravenous in Sinus Surgery

Mass Eye and Ear

Status and phase: Unknown; Phase 3

Conditions: Acetaminophen

Treatments: Drug: Acetaminophen

Study type: Interventional

Funder types: Other

Identifiers

NCT03295214

1098410

Details and patient eligibility

About

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.

Full 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.

Enrollment: 124 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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124 participants in 2 patient groups

Acetaminophen 975mg Per Os

Active Comparator group

Description:

975mg of Acetaminophen given by mouth

Treatment:

Drug: Acetaminophen

Acetaminophen 1000mg Intravenous

Active Comparator group

Description:

1000mg of Acetaminophen given intravenously

Treatment:

Drug: Acetaminophen