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.
Phase:
Phase 4
Details
Lead Sponsor:
Stanford University
Collaborators:
Albert Einstein College of Medicine Albert Einstein College of Medicine, Inc. Mayo Clinic NorthShore University HealthSystem University of British Columbia Vanderbilt University Medical Center