Acetaminophen Given Per Os and Intravenous in Sinus Surgery

Acetaminophen Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03295214
• Other study ID #: 1098410
• Status: Recruiting
• Phase: Phase 3
• Start date: March 28, 2018
• Est. completion date: March 2020

Study information

• Verified date: April 2019
• Source: Massachusetts Eye and Ear Infirmary
• Contact: Amy Quinkert, PhD
• Phone: 6175734192
• Email: amy_quinkert[@]meei.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 124
• Est. completion date: March 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acetaminophen

Intervention

Drug:
• Acetaminophen
Acetaminophen given for pain relief

Locations

Country	Name	City	State
United States	Massachusetts Eye and Ear	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts Eye and Ear Infirmary

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS for pain	First VAS pain score applied	0-1 hour
Secondary	Opioid Use	Postoperative opioid consumption for pain control	24 hours
Secondary	Time in PACU	Time required to be admitted and discharged home	3-5 hours
Secondary	VAS for pain	Second VAS pain score applied	1-2 hours
Secondary	VAS for pain	Third VAS pain score applied	2-3 hours
Secondary	VAS for pain	Last VAS pain score applied	24 hours
Secondary	PONV	Incidence of PONV	24 hours