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NCT03783702 · ClinicalTrials.gov registry record · Phase 4
Pain Control Following Sinus Surgery
A Phase 4 study, sponsored by Stanford University.
- Completed
- Registry status
- Phase 4
- Development phase
- 118
- Enrollment target
NCT03783702: Completed Phase 4 study, sponsored by Stanford University.
NCT03783702 is a Phase 4 study that has completed, run by Stanford University. The registered enrollment target is 118 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03783702, a Phase 4 study, has completed, sponsored by Stanford University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 118 participants
- Enrollment target
Study 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.
Primary Outcome
A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no pain" with a score of 0 to "worst imaginable pain," corresponding to a score of 100.
Interventions
- DRUG OxyCODONE 5 Mg (milligram) Oral Tablet
- DRUG Ibuprofen 600 Mg (milligram) Oral Tablet
- DRUG Acetaminophen 650 MG (milligram) Oral Tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 118 participants |
| Start Date | 2019-04-04 |
| Est. Completion | 2020-12-30 |
| Phase | Phase 4 |
What the finished NCT03783702 record still lists
NCT03783702 is an interventional study that assigns participants to a tested intervention. The registered 118 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 3 interventions - of which OxyCODONE 5 Mg (milligram) Oral Tablet is the first listed.
NCT03783702 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03783702 about?
NCT03783702 is a clinical study titled "Pain Control Following Sinus Surgery". 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...
What is the current status of trial NCT03783702?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 118 participants. The study started on 2019-04-04. Estimated completion is 2020-12-30.
What interventions are being tested in trial NCT03783702?
The interventions under investigation include: OxyCODONE 5 Mg (milligram) Oral Tablet (DRUG), Ibuprofen 600 Mg (milligram) Oral Tablet (DRUG), Acetaminophen 650 MG (milligram) Oral Tablet (DRUG).
Who is sponsoring clinical trial NCT03783702?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03783702's enrollment target sits among peer trials
118 713th of 2000 higher than 1,287 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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