Acetaminophen Given Per Os and Intravenous in Sinus Surgery

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.

Study Overview

• Status: Unknown
• Conditions: Acetaminophen
• Intervention / Treatment: Drug: Acetaminophen

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 Type: Interventional
• Enrollment (Anticipated): 124
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Amy Quinkert, PhD; Phone Number: 6175734192; Email: amy_quinkert@meei.harvard.edu
• Study Contact Backup: Name: Iuliu Fat, MD; Phone Number: 617-573-3380; Email: iuliu_fat@meei.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts Eye and Ear
      • Contact: Brendan McBrine, BS; Phone Number: 617-573-6815; Email: brendan_mcbrine@meei.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Massachusetts Eye and Ear Infirmary
• Investigators: Principal Investigator: Iuliu Fat, MD, MEEI

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2018
• Primary Completion (Anticipated): March 1, 2020
• Study Completion (Anticipated): March 1, 2020

Study Registration Dates

• First Submitted: September 21, 2017
• First Submitted That Met QC Criteria: September 22, 2017
• First Posted (Actual): September 27, 2017

Study Record Updates

• Last Update Posted (Actual): April 10, 2019
• Last Update Submitted That Met QC Criteria: April 8, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Acetaminophen; Functional Endoscopic Sinus Surgery
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Acetaminophen
• Other Study ID Numbers: 1098410

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No