Post-operative Pain Control With Acetaminophen and Ibuprofen After Functional Endoscopic Sinus Surgery

NCT05287217 | Terminated

• 1 other identifier: 2021-1249
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The safest and most effective post-operative pain control regimen after functional endoscopic sinus surgery (FESS) has been the subject of persistent research. This prospective study will compare post-operative pain control when managed either by a defined medication schedule or medication taken on an as-needed basis after functional endoscopic sinus surgery for chronic rhinosinusitis. Prior to surgery, patients will be randomly selected to be in one of two treatment arms. One group will receive instructions to take specific medications (acetaminophen and ibuprofen on a specific schedule post-operatively. The second treatment groups will be instructed to take the same medications but on an as needed basis for pain. Patients will also be provided with an option of a limited supply of narcotic analgesics for pain should they be needed. Post-operative pain control will be assessed by the patient with a pain-diary documenting perceived levels of pain for 10 days post-operatively using a validated visual analog scale. At the conclusion of the study the records of medications taken along with pain responses will be compared between groups

Conditions

Chronic Rhinosinusitis (Diagnosis)

Keywords

Pain Control

Outcome Measures

Primary Outcomes (1)

• Scheduled versus as needed pain management following FESS surgery

  The primary outcome measure will compare patient self-assessed pain levels, between the 2 study groups, using a Faces Pain Scale Record. The faces pain scale ranges from 0 to 10 with 0 being no pain and 10 being worst possible pain. Each number on the scale is associated with a pain description and an animated face associated with the description.

  10 days

Secondary Outcomes (1)

• Does scheduled pain management decrease narcotic use.

  10 days

Study Arms (2)

Group 1: Scheduled pain control

ACTIVE COMPARATOR

Group 1 patients will be instructed to take 650mg of acetaminophen every 6 hours and 600mg of ibuprofen every 8 hours for 10 consecutive days after surgery regardless of whether they experience pain or not.

Other: Comparison of medication administration for pain control

Group 2: Pain control as needed.

ACTIVE COMPARATOR

Group 2 patients will be instructed to take the 650mg of acetaminophen every 6 hours and 600mg of ibuprofen every 8 hours for 10 days after surgery only when needed to control pain.

Other: Comparison of medication administration for pain control

Interventions

Comparison of medication administration for pain control OTHER

Measuring pain control following FESS surgery

Group 1: Scheduled pain control; Group 2: Pain control as needed.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females ≥18 years of age.
• Patients of the PI (Dr. Joe) scheduled for sinus surgery at UI Health.
• Patients with CRS defined as greater than 12 weeks of 2 of the 4 following symptoms: nasal obstruction/congestion, mucopurulent discharge (nasal or postnasal), facial pain/pressure, or decreased/loss of smell + endoscopic/radiographic evidence of disease.
• CRS patients with or without nasal polyps.
• Patients who are COVID-19 negative.
• Patients that understand the purpose and procedures of the study and who agree to participate.
• Patients who have the capacity to consent autonomously.

You may not qualify if:

• Males and females \< 18 years of age.
• Patients of the PI (Dr. Joe) who are not scheduled for sinus surgery at UI Health.
• Patients who do not have CRS.
• Patients who have allergies to acetaminophen, ibuprofen, and related non-steroidal anti-inflammatory drugs (NSAIDS).
• Patients with kidney or liver dysfunction, cirrhosis, metabolic deficiencies, inflammatory bowel disease, peptic ulcer disease, chronic malnutrition, who have had a previous skull base surgery, or who are currently undergoing cancer treatment.
• Woman who are pregnant or breastfeeding will be excluded.
• Patients with a history of drug and/or narcotic abuse will be excluded.
• COVID-19 positive patients.
• Patients who are not able to understand the purpose and procedures of the study and who do not wish to participate.
• Patients that do not have the capacity to consent autonomously.

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

University of Illinois at Chicago, Department of Otolaryngology-Head and Neck Surgery

Chicago, Illinois, 60612, United States

Location

Related Publications (14)

• Bhattacharyya N. Ambulatory sinus and nasal surgery in the United States: demographics and perioperative outcomes. Laryngoscope. 2010 Mar;120(3):635-8. doi: 10.1002/lary.20777.

  PMID: 20058315 BACKGROUND

• [2] Substance Abuse and Mental Health Services Administration. (2019). Key substance use and mental health indicators in the United States: Results from the 2018 National Survey on Drug Use and Health (HHS Publication No. PEP19-5068, NSDUH Series H-54). Rockville, MD: Center for Behavioral Health Statistics and Quality, Substance Abuse and Mental Health Services Administration. Retrieved from https://www.samhsa.gov/data/

  BACKGROUND

• Gray ML, Fan CJ, Kappauf C, Kidwai S, Colley P, Iloreta AM, Govindaraj S. Postoperative pain management after sinus surgery: a survey of the American Rhinologic Society. Int Forum Allergy Rhinol. 2018 Oct;8(10):1199-1203. doi: 10.1002/alr.22181. Epub 2018 Jul 18.

  PMID: 30019397 BACKGROUND

• Nguyen KK, Liu YF, Chang C, Park JJ, Kim CH, Hondorp B, Vuong C, Xu H, Crawley BK, Simental AA, Church CA, Inman JC. A Randomized Single-Blinded Trial of Ibuprofen- versus Opioid-Based Primary Analgesic Therapy in Outpatient Otolaryngology Surgery. Otolaryngol Head Neck Surg. 2019 May;160(5):839-846. doi: 10.1177/0194599819832528. Epub 2019 Mar 5.

  PMID: 30832548 BACKGROUND

• Wu AW, Walgama ES, Genc E, Ting JY, Illing EA, Shipchandler TZ, Higgins TS. Multicenter study on the effect of nonsteroidal anti-inflammatory drugs on postoperative pain after endoscopic sinus and nasal surgery. Int Forum Allergy Rhinol. 2020 Apr;10(4):489-495. doi: 10.1002/alr.22506. Epub 2019 Dec 13.

  PMID: 31834679 BACKGROUND

• Poljak D, Chappelle J. The effect of a scheduled regimen of acetaminophen and ibuprofen on opioid use following cesarean delivery. J Perinat Med. 2020 Feb 25;48(2):153-156. doi: 10.1515/jpm-2019-0322.

  PMID: 31951589 BACKGROUND

• Shelton FR, Ishii H, Mella S, Chew D, Winterbottom J, Walijee H, Brown R, Chisholm EJ. Implementing a standardised discharge analgesia guideline to reduce paediatric post tonsillectomy pain. Int J Pediatr Otorhinolaryngol. 2018 Aug;111:54-58. doi: 10.1016/j.ijporl.2018.05.020. Epub 2018 May 19.

  PMID: 29958614 BACKGROUND

• Kemppainen TP, Tuomilehto H, Kokki H, Seppa J, Nuutinen J. Pain treatment and recovery after endoscopic sinus surgery. Laryngoscope. 2007 Aug;117(8):1434-8. doi: 10.1097/MLG.0b013e3180600a16.

  PMID: 17572643 BACKGROUND

• Gao Y, Wang C, Wang G, Cui X, Yang G, Lou H, Zhang L. Benefits of Enhanced Recovery After Surgery in Patients Undergoing Endoscopic Sinus Surgery. Am J Rhinol Allergy. 2020 Mar;34(2):280-289. doi: 10.1177/1945892419892834. Epub 2019 Dec 4. No abstract available.

  PMID: 31799861 BACKGROUND

• Svider PF, Nguyen B, Yuhan B, Zuliani G, Eloy JA, Folbe AJ. Perioperative analgesia for patients undergoing endoscopic sinus surgery: an evidence-based review. Int Forum Allergy Rhinol. 2018 Jul;8(7):837-849. doi: 10.1002/alr.22107. Epub 2018 Apr 12.

  PMID: 29645361 BACKGROUND

• Du E, Farzal Z, Stephenson E, Tanner A, Adams K, Farquhar D, Weissler M, Patel S, Blumberg J, Jowza M, Hackman T, Zanation A. Multimodal Analgesia Protocol after Head and Neck Surgery: Effect on Opioid Use and Pain Control. Otolaryngol Head Neck Surg. 2019 Sep;161(3):424-430. doi: 10.1177/0194599819841885. Epub 2019 Apr 9.

  PMID: 30961428 BACKGROUND

• Oltman J, Militsakh O, D'Agostino M, Kauffman B, Lindau R, Coughlin A, Lydiatt W, Lydiatt D, Smith R, Panwar A. Multimodal Analgesia in Outpatient Head and Neck Surgery: A Feasibility and Safety Study. JAMA Otolaryngol Head Neck Surg. 2017 Dec 1;143(12):1207-1212. doi: 10.1001/jamaoto.2017.1773.

  PMID: 29049548 BACKGROUND

• Bijur PE, Silver W, Gallagher EJ. Reliability of the visual analog scale for measurement of acute pain. Acad Emerg Med. 2001 Dec;8(12):1153-7. doi: 10.1111/j.1553-2712.2001.tb01132.x.

  PMID: 11733293 BACKGROUND

• Ferreira-Valente MA, Pais-Ribeiro JL, Jensen MP. Validity of four pain intensity rating scales. Pain. 2011 Oct;152(10):2399-2404. doi: 10.1016/j.pain.2011.07.005.

  PMID: 21856077 BACKGROUND

MeSH Terms

Conditions

Disease; Agnosia

Interventions

Analgesia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Study Officials

• Stephanie Joe, MD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Adult patients will be screened and consented. Group assignment will be determined on an alternating basis. After FESS surgery patients will be given post-operative pain management instructions according to group assignment. Group 1 will take 650mg of acetaminophen every 6 hours and 600mg of ibuprofen every 8 hours for 10 consecutive days after surgery regardless of whether they experience pain or not. Group 2 will take the 650mg of acetaminophen every 6 hours and 600mg of ibuprofen every 8 hours for 10 days after surgery only when needed to control pain. Patients in both groups will record post-operative pain medications for 10 consecutive days after surgery and their level of pain once per day. The patients' post-op follow-up visit will occur 10-14 days after surgery. Medications prescribed for this study are standard of care following FESS surgery. The instructed use of the medications following surgery are being done strictly for comparative and research purposes.

Study Record Dates

• First Submitted: February 1, 2022
• First Posted: March 18, 2022
• Study Start: July 29, 2022
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)