An interventional study of Comparison of medication administration for pain control in Chronic Rhinosinusitis (Diagnosis), sponsored by University of Illinois at Chicago. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-20.
Sponsored by University of Illinois at Chicago · Not applicable, Interventional, and Supportive care
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
The safest and most effective post-operative pain control regimen after functional endoscopic sinus surgery (FESS) has been the subject of persistent debate and research for many years. The main reasons for this debate is due to two factors: 1) endoscopic sinus surgery is a commonly performed as an outpatient procedure by both generalist and sub-specialized Otolaryngologists. Therefore, there is limited controlled data on pain levels and pain control post-surgery. 2) The ongoing opiate crisis in the United States raises concern of over-prescribing narcotic pain medication post-surgery when it is not necessary.
Of the 600,000 ambulatory sinonasal procedures performed annually in the United States, over 255,000 are sinus surgeries.1 Coupled with an estimated 2 million Americans suffering from opioid use disorders, there is a necessity for further research into minimizing the use of opioids for pain management as well as for testing non-opioid pain management options for postoperative FESS patients.
This study builds on prior research studying optimal non-narcotic analgesia after FESS. A 2018 survey by the American Rhinologic Society showed that over 90% of responders prescribed at least one type of opioid for postoperative pain after FESS. While the majority of Otolaryngologists routinely prescribe opioids, several studies have demonstrated that acetaminophen and NSAIDs can be just as effective in managing postoperative pain in FESS patients. Despite prior concerns that ibuprofen increases risk of epistaxis after FESS, it has been shown that bleeding complications following FESS are negligible.
Recent literature in other surgical sub-specialties has shown that scheduled non-narcotic pain medication significantly reduced patient's post-operative pain scores as compared to those taking it on an as-needed basis.6 In Otolaryngology, the practice of scheduled acetaminophen and ibuprofen has been documented to reduce admissions due to post-tonsillectomy pain.7 Despite the rising trend of non-narcotic pain regimens after surgery, the most appropriate method for instituting this in FESS patients has only been briefly evaluated. A 2006 study showed that scheduled medication use versus as-needed modified-release acetaminophen allowed patients to return to normal daily activities more rapidly and with less pain than patients taking post-operative pain medications on an as needed basis. However, this pain regimen did not include NSAIDs, and modified release acetaminophen is not commonly available in the United States.
This study will evaluate post-operative pain management in patients undergoing outpatient functional endoscopic sinus surgery. Patients will be randomized into one of two study groups: Group 1: Patients instructed to follow a predetermined post-operative acetaminophen and ibuprofen medication schedule, and Group 2: patients instructed to take acetaminophen and ibuprofen as needed after the onset of pain/discomfort. Additionally, all patients in both study groups will be provided a limited number of narcotic pills (Norco) for pain. Patients will be advised to only take the pills for pain that is not controlled by the post-operative acetaminophen and ibuprofen medications.
Pain control will be self-assessed by each patient for the first 10 days after surgery using a validated visual-analog scale (VAS).
330 studies on the registry are indexed under Rhinosinusitis; 55 are open to participants now.
This study's enrollment of 60 is close to the median of 60 across 227 interventional studies indexed under Rhinosinusitis.
Browse Rhinosinusitis studies →University of Illinois at Chicago is the lead sponsor of 515 studies on the registry; 133 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 18 (58%) have results posted.
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Exclusion Criteria:
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 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
Measuring pain control following FESS surgery
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.
Time frame: 10 days
Does scheduled pain management decrease narcotic use.
The second outcome measure will quantify (count) the number of narcotic (Norco) pills taken by each patient post-operatively in the 2 study groups.
Time frame: 10 days
Plan to share: No
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University of Illinois at Chicago