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NCT03055507 · ClinicalTrials.gov registry record · Phase 2
Effect of Post-operative Ibuprofen After Surgery for Chronic Rhinosinusitis
A Phase 2 study, sponsored by University of Washington.
- Completed
- Registry status
- Phase 2
- Development phase
- 42
- Enrollment target
NCT03055507: Completed Phase 2 study, sponsored by University of Washington.
NCT03055507 is a Phase 2 study that has completed, run by University of Washington. The registered enrollment target is 42 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03055507, a Phase 2 study, has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 42 participants
- Enrollment target
Study Summary
Endoscopic sinus surgery (ESS) for chronic rhinosinusitis (CRS) is a common procedure in the US, with about 250,000 cases performed annually. Currently, there is no consensus, evidence-based post-operative pain regimen; with the majority of practitioners opting for a combination of acetaminophen and narcotics for pain control. Most rhinologists avoid NSAIDs due to decreased platelet aggregation and the theoretical risk of increased post-operative bleeding. No studies to date have evaluated the use of ibuprofen in CRS patients following ESS. Additionally, there is a lack of information regarding the average narcotic requirement following ESS. The purpose of this pilot prospective cohort study is to evaluate the use of narcotics in sinus surgery and the effect of ibuprofen in the non-packed nose following ESS. This investigation will help to gain understanding of current opioid use in post-op sinus patients and assess the safety and effectiveness of post-operative ibuprofen administration on pain. The investigators aim to quantify the average narcotic use following ESS, as well as evaluate the effect of the addition of ibuprofen to the standard analgesic regimen on pain scores and post-operative epistaxis. The investigators hypothesize that the use of ibuprofen will decrease pain scores on a 10-cm visual analogue scale when compared with individuals who do not use ibuprofen post-operatively, this will lead to decreased opioid use in the post-operative period. Additionally, the investigators hypothesize no increase in post-operative bleeding rates, again based on a 10-cm visual analogue scale and bleeding events. In summary, this will be the first study to the investigators knowledge to examine the effect of post-operative ibuprofen use and its effects on opioid use, as well as pain and epistaxis outcomes, in ESS. By performing this pilot prospective cohort study, the investigators will be equipped to design and perform the optimal prospective, randomized study evalu
Primary Outcome
10-cm visual analogue scale used to indicate level of post-operative pain. 0 indicates no pain and 10 indicates worst pain imaginable.
Interventions
- DRUG Ibuprofen 400 mg
- DRUG OxyCODONE 5 Mg Oral Tablet
- DRUG Acetaminophen 650 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2017-04-01 |
| Est. Completion | 2017-12-31 |
| Phase | Phase 2 |
What the finished NCT03055507 record still lists
NCT03055507 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 3 interventions - of which Ibuprofen 400 mg is the first listed.
NCT03055507 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03055507 about?
NCT03055507 is a clinical study titled "Effect of Post-operative Ibuprofen After Surgery for Chronic Rhinosinusitis". Endoscopic sinus surgery (ESS) for chronic rhinosinusitis (CRS) is a common procedure in the US, with about 250,000 cases performed annually. Currently, there is no consensus, evidence-based post-operative pain regimen; with the majority of practitioners opting for a combination of acetaminophen and...
What is the current status of trial NCT03055507?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 42 participants. The study started on 2017-04-01. Estimated completion is 2017-12-31.
What interventions are being tested in trial NCT03055507?
The interventions under investigation include: Ibuprofen 400 mg (DRUG), OxyCODONE 5 Mg Oral Tablet (DRUG), Acetaminophen 650 mg (DRUG).
Who is sponsoring clinical trial NCT03055507?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03055507's enrollment target sits among peer trials
42 1339th of 2000 higher than 649 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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