Pain Control Following Sinus Surgery
Condition: Sinusitis; Opioid Use; Opioid Abuse; Narcotic Use; Otolaryngologic Disease; Postoperative Pain; Pain
MeSH terms: Sinusitis; Otorhinolaryngologic Diseases; Opioid-Related Disorders
Intervention: OxyCODONE 5 Mg (milligram) Oral Tablet; Ibuprofen 600 Mg (milligram) Oral Tablet; Acetaminophen 650 MG (milligram) Oral Tablet
Intervention description: Oxycodone will be the second-line treatment in the control group and the third-line treatment in the experimental group.; Patients in the experimental group will receive ibuprofen 600mg as the second-line analgesic.; All patients will receive acetaminophen as the first-line analgesic.
Intervention MeSH terms: Acetaminophen; Ibuprofen; Oxycodone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will be randomized into one of two groups: one will receive acetaminophen and oxycodone while the other will receive acetaminophen, ibuprofen, and oxycodone.
Masking: None (Open Label)
Enrollment: 118.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Given the ongoing national opioid epidemic, an increased interest has developed in optimizing
      opioid prescribing practices of physicians, including otolaryngologists. Endoscopic sinus
      surgery (ESS) is one of the most commonly performed surgeries by otolaryngologists with over
      250,000 ESS's performed annually in the U.S. Multiple studies have shown that, compared to
      the amount patients actually consume, otolaryngologists prescribe a high quantity of opioids
      to patients recovering from ESS). It has been shown that these excess opioid medications
      contribute to prolonged use or abuse by the patient, family members, or friends. The purpose
      of this study is to better understand the pain management requirements of patients who
      undergo ESS for recurrent acute rhinosinusitis (RARS) or chronic rhinosinusitis (CRS).

      This prospective, randomized, multi-institutional controlled trial will aim to determine the
      degree to which pain following ESS can be adequately controlled by non-opioid medications. It
      will also determine whether post-ESS narcotic use can be avoided entirely, or at least
      significantly limited. Patients will be randomized into two groups, each of which will
      receive a stepwise analgesic regimen consisting of acetaminophen and oxycodone or
      acetaminophen and ibuprofen. Pain will be assessed daily using visual analog scales (VAS) and
      the Brief Pain Inventory (BPI).

      The results of this study will help to develop a standardized approach to pain management in
      the post-ESS setting and help to elucidate the role of non-opioid pain medications. The
      ultimate goal would be to positively affect opioid prescribing patterns among surgeons who
      perform ESS in order to significantly reduce the quantity of opioids prescribed to patients
      while continuing to adequately manage patients' pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years or older

          -  English-speaking

          -  Scheduled to undergo endoscopic sinus surgery for sinusitis (CRSwNP, CRSsNP, or RARS)

          -  Can commit to follow up for at least one postoperative visit

        Exclusion Criteria:

        Patients undergoing a septorhinoplasty (septoplasty permissible if patient will also
        undergo sinus surgery)

          -  Doyle splints to be used

          -  Alcohol or opioid use disorder

          -  History of chronic pain disorders

          -  Regular use of acetaminophen/NSAIDS (>4x per week)

          -  Patients who use narcotics or neuromodulating drugs (e.g. gabapentin,
             nortriptyline)more than 2x per week on average.

          -  Gastrointestinal ulcers or bleeding

          -  Chronic kidney disease/known decreased renal function (estimated glomerular filtration
             rate <60)

          -  Liver cirrhosis or other hepatic impairment

          -  Prior adverse reaction to opioids or NSAIDS

          -  Other contraindications to any drug classes in either group.