Acetaminophen Given Per Os and Intravenous in Sinus Surgery
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Acetaminophen 975mg Per Os 975mg of Acetaminophen given by mouth |
Drug: Acetaminophen
Acetaminophen given for pain relief
|
| Active Comparator: Acetaminophen 1000mg Intravenous 1000mg of Acetaminophen given intravenously |
Drug: Acetaminophen
Acetaminophen given for pain relief
|
Outcome Measures
Primary Outcome Measures
- VAS for pain [0-1 hour]
First VAS pain score applied
Secondary Outcome Measures
- 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 [1-2 hours]
Second VAS pain score applied
- VAS for pain [2-3 hours]
Third VAS pain score applied
- VAS for pain [24 hours]
Last VAS pain score applied
- PONV [24 hours]
Incidence of PONV
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Massachusetts Eye and Ear | Boston | Massachusetts | United States | 02114 |
Sponsors and Collaborators
- Massachusetts Eye and Ear Infirmary
Investigators
- Principal Investigator: Iuliu Fat, MD, MEEI
Study Documents (Full-Text)
None provided.More Information
Publications
- Carroll NV, Miederhoff PA, Cox FM, Hirsch JD. Costs incurred by outpatient surgical centers in managing postoperative nausea and vomiting. J Clin Anesth. 1994 Sep-Oct;6(5):364-9.
- DeLoach LJ, Higgins MS, Caplan AB, Stiff JL. The visual analog scale in the immediate postoperative period: intrasubject variability and correlation with a numeric scale. Anesth Analg. 1998 Jan;86(1):102-6.
- Fenlon S, Collyer J, Giles J, Bidd H, Lees M, Nicholson J, Dulai R, Hankins M, Edelman N. Oral vs intravenous paracetamol for lower third molar extractions under general anaesthesia: is oral administration inferior? Br J Anaesth. 2013 Mar;110(3):432-7. doi: 10.1093/bja/aes387. Epub 2012 Dec 6.
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