Acetaminophen Given Per Os and Intravenous in Sinus Surgery

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Acetaminophen

Intervention / Treatment
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* Drug: Acetaminophen


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Acetaminophen 975mg Per Os<br>975mg of Acetaminophen given by mouth | Drug: Acetaminophen<br>* Acetaminophen given for pain relief<br>|
| Active Comparator: Acetaminophen 1000mg Intravenous<br>1000mg of Acetaminophen given intravenously | Drug: Acetaminophen<br>* Acetaminophen given for pain relief<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS for pain | First VAS pain score applied | 0-1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid Use | Postoperative opioid consumption for pain control | 24 hours | 
| Time in PACU | Time required to be admitted and discharged home | 3-5 hours | 
| VAS for pain | Second VAS pain score applied | 1-2 hours | 
| VAS for pain | Third VAS pain score applied | 2-3 hours | 
| VAS for pain | Last VAS pain score applied | 24 hours | 
| PONV | Incidence of PONV | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acetaminophen, Functional Endoscopic Sinus Surgery