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NCT04563494 · ClinicalTrials.gov registry record · Phase 4
The Effects of IV vs Oral Dexamethasone on Postoperative Nausea, Vomiting, and Pain
A Phase 4 study, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- Phase 4
- Development phase
- 127
- Enrollment target
NCT04563494 is a Phase 4 study that has completed, run by University of Colorado, Denver. The registered enrollment target is 127 participants.
The verdict
NCT04563494, a Phase 4 study, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 127 participants
- Enrollment target
Study Summary
The hypothesis being tested in this study is that perioperative oral administration of dexamethasone, when compared to intravenous (IV) administration, offers a similar reduction in postoperative nausea and vomiting (PONV), and reduction in postoperative pain in pediatric patients undergoing tonsillectomy with or without adenoidectomy and/or tympanostomy tube placement. The specific aim of this study is to demonstrate non-inferiority of oral dexamethasone when compared to IV dexamethasone, given that there is currently a severe, sudden, and world-wide shortage of IV dexamethasone given its recent use in treating patients with covid19 disease.
Interventions
- DRUG dexamethasone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 127 participants |
| Start Date | 2020-10-23 |
| Est. Completion | 2023-05-24 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04563494
The ClinicalTrials.gov registry entry for NCT04563494 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 127 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which dexamethasone is the first listed.
NCT04563494 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04563494 about?
NCT04563494 is a clinical study titled "The Effects of IV vs Oral Dexamethasone on Postoperative Nausea, Vomiting, and Pain". The hypothesis being tested in this study is that perioperative oral administration of dexamethasone, when compared to intravenous (IV) administration, offers a similar reduction in postoperative nausea and vomiting (PONV), and reduction in postoperative pain in pediatric patients undergoing tonsill...
What is the current status of trial NCT04563494?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 127 participants. The study started on 2020-10-23. Estimated completion is 2023-05-24.
What interventions are being tested in trial NCT04563494?
The interventions under investigation include: dexamethasone (DRUG).
Who is sponsoring clinical trial NCT04563494?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
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