Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-26 @ 2:32 AM
Study NCT ID:
NCT03783702
Status:
COMPLETED
Last Update Posted:
2021-09-01
First Post:
2018-12-19
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Pain Control Following Sinus Surgery
Sponsor:
Stanford University
Organization:
Study Overview
Official Title:
Multi-institutional, Randomized Controlled Trial Assessing Opioid Use and Analgesic Requirements After Endoscopic Sinus Surgery
Status:
COMPLETED
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: