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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 is a Phase 2 study that has completed, run by University of Washington. The registered enrollment target is 42 participants.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03055507
The ClinicalTrials.gov registry entry for NCT03055507 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Washington, which has 1,048 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Ibuprofen 400 mg is the first listed.
NCT03055507 reports 0 study locations.
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.
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