Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 4 study, sponsored by University of Colorado, Denver.
NCT04563494 is a Phase 4 study that has completed, run by University of Colorado, Denver. The registered enrollment target is 127 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Post-operative nausea assessed during the post-anesthesia care unit (PACU) stay (4 hours after surgery).
Interventions
- DRUG dexamethasone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 127 participants |
| Start Date | 2020-10-23 |
| Est. Completion | 2023-05-24 |
| Phase | Phase 4 |
What the finished NCT04563494 record still lists
NCT04563494 is an interventional study that assigns participants to a tested intervention. The registered 127 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 (75% lower).
The record links to 0 conditions, and to 1 intervention - of which dexamethasone is the first listed.
NCT04563494 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04563494's enrollment target sits among peer trials
127 639th of 2000 higher than 1,355 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03017820 · 127 participants · Phase 1
A Vaccine (VSV-hIFNβ-NIS) With or Without Cyclophosphamide and Combinations of Ipilimumab, Nivolumab, and Cemiplimab in Treating Relapsed or Refractory Multiple Myeloma, Acute Myeloid Leukemia or Lymphoma
- NCT03609580 · 127 participants · Phase 1
Post-operative Urinary Retention (POUR) Following Thoracic Surgery
- NCT06285643 · 127 participants · Phase 2
A Study of AAV2-GDNF in Adults With Moderate Parkinson's Disease (REGENERATE-PD)
- NCT06809400 · 127 participants · Phase 1
A Study of LY4006896 in Healthy Participants and Participants With Parkinson's Disease
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI