Acetaminophen Given Per Os and Intravenous in Sinus Surgery
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/26/2018 |
| Start Date: | March 28, 2018 |
| End Date: | March 2019 |
| Contact: | Amy Quinkert, PhD |
| Email: | amy_quinkert@meei.harvard.edu |
| Phone: | 6175734192 |
A Prospective Clinical Trial Evaluating the Post-Operative Analgesic Effects of Acetaminophen Given Per Os and Intravenous
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.
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.
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.
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.
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
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