CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 118 enrolled
Drug / intervention
OxyCODONE 5 Mg (milligram) Oral Tablet +2 moredrug
Likely dose
OxyCODONE 5 Mg (milligram) Oral Tabletfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03783702
NCT03783702Phase 4Completed

Multi-institutional, Randomized Controlled Trial Assessing Opioid Use and Analgesic Requirements After Endoscopic Sinus Surgery

Stanford University·interventional·Posted Dec 21, 2018·Updated Sep 1, 2021

In Brief

A Phase 4 clinical trial evaluating OxyCODONE 5 Mg (milligram) Oral Tablet, Ibuprofen 600 Mg (milligram) Oral Tablet, and 1 other intervention for Sinusitis and 6 related conditions. Completed, enrolled 118 participants across 6 sites in 2 countries.

Detailed 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.

Study Details

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedDec 21, 2018
Enrollment StartApr 4, 2019
Primary CompletionJul 1, 2020
Study CompletionDec 30, 2020
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 7.5 years ago

Interventions

OxyCODONE 5 Mg (milligram) Oral Tabletdrug

Oxycodone will be the second-line treatment in the control group and the third-line treatment in the experimental group.

Ibuprofen 600 Mg (milligram) Oral Tabletdrug

Patients in the experimental group will receive ibuprofen 600mg as the second-line analgesic.

Acetaminophen 650 MG (milligram) Oral Tabletdrug

All patients will receive acetaminophen as the first-line analgesic.