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

TerminatedNot applicableNCT05287217
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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

Study details

Official title
Post-operative Pain Control With Acetaminophen and Ibuprofen After Functional Endoscopic Sinus Surgery for Chronic Rhinosinusitis: a Prospective Study.
Conditions
  • Chronic Rhinosinusitis (Diagnosis)
Interventions
  • Other: Comparison of medication administration for pain control
Sponsor
University of Illinois at Chicago
Start date
2022-07-29
Primary completion
2023-06-30
Sex
All
Age range
from 18 Years
Results posted
No results posted in this snapshot
Countries
United States
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05287217