Patient Selection, Enrollment, and Study Protocols

This clinical trial enrolled English-speaking individuals 18 years or older with a diagnosis of CRS, as defined by the International Consensus Statement on Allergy and Rhinology: Chronic Rhinosinusitis⁸ that were scheduled to undergo ESS. Exclusion criteria included contraindication to NSAID use, such as peptic ulcer disease, chronic kidney disease, or aspirin exacerbated respiratory disease, subjective NSAID intolerance, previous history of bleeding disorder, sinonasal malignancy, cystic fibrosis, history of chronic pain, fibromyalgia, opioid addiction/dependence, preoperative daily use of analgesic medication, or need for open or Draf 3 frontal sinus procedure.⁹

Eligible patients were approached at their preoperative clinic visit by the study team. Patients were given the opportunity to self-select which treatment arm to participate. The control patients were prescribed acetaminophen 650 mg every 6 hours initially scheduled then as needed for pain once the patient no longer felt the need for scheduled pain medication. Oxycodone 5 mg every 3 hours as needed for pain was also prescribed to patients in this treatment arm. Patients were allowed to self-select the point at which they stopped taking scheduled medication and transitioned to as needed administration. The investigation patients were prescribed the same prescriptions with the addition of ibuprofen 400 mg every 6 hours to be alternated with acetaminophen so that ibuprofen alternating with acetaminophen was being consumed every 3 hours. Both acetaminophen and ibuprofen were written to be taken scheduled. Once the patient no longer felt the need for scheduled pain medication, then these medications were taken as needed.

Patients were enrolled in REDcap, a HIPAA secure data collection tool. Baseline demographic information and sinus disease severity using the Sinonasal Outcome Test-22 score (SNOT-22), Lund-Kennedy endoscopy score, and Lund-MacKay CT severity score were recorded. Additional details were recorded including number of sinuses operated on, concomitant septoplasty during sinus surgery, estimated blood loss per operative report, duration of surgery per nursing record, use of hemostatic agents and nasal packing intraoperatively, and presence of sinus related comorbidities such as CRS with nasal polyposis or immunodeficiency. All patients received dexamethasone 10 mg intravenously perioperatively.