Clinical trial NCT03295214: Acetaminophen Given Per Os and Intravenous in Sinus Surgery
Official title: A Prospective Clinical Trial Evaluating the Post-Operative Analgesic Effects of Acetaminophen Given Per Os and Intravenous
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Acetaminophen
Keywords: Acetaminophen
Functional Endoscopic Sinus Surgery
Lead sponsor: Massachusetts Eye and Ear Infirmary
Sponsor class: OTHER
First posted: 2017-09-27
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility 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

Primary outcomes:
measure: VAS for pain
timeFrame: 0-1 hour
Secondary outcomes:
measure: Opioid Use
timeFrame: 24 hours
measure: Time in PACU
timeFrame: 3-5 hours
measure: VAS for pain
timeFrame: 1-2 hours
measure: VAS for pain
timeFrame: 2-3 hours
measure: VAS for pain
timeFrame: 24 hours
measure: PONV
timeFrame: 24 hours
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts Eye and Ear
state: Massachusetts
Study officials:
affiliation: MEEI
name: Iuliu Fat, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1016/s0952-8180(05)80004-2.
citation: 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. doi: 10.1097/00000539-199801000-00020.
citation: 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.