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NCT04879823 · ClinicalTrials.gov registry record · Phase 3
Post-operative Course of Dexamethasone to Reduce Tonsillectomy Morbidity
A Phase 3 study, sponsored by David Chi, MD.
- Terminated
- Registry status
- Phase 3
- Development phase
- 222
- Enrollment target
NCT04879823: Clinical Trial Phase 3 study, sponsored by David Chi, MD.
NCT04879823 is a Phase 3 study that was terminated before completion, run by David Chi, MD. The registered enrollment target is 222 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04879823, a Phase 3 study, was terminated before completion, sponsored by David Chi, MD.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 222 participants
- Enrollment target
Study Summary
The goal of this study is determine if an oral systemic course of steroids is a safe and effective option in lowering pain and complications following adenotonsillectomy in various pediatric age groups. A double blind, placebo-controlled randomized clinical trial of steroids (dexamethasone) versus placebo postoperatively will be performed. Investigators will determine if there is a difference in post-operative pain and complications between groups.
Primary Outcome
Average pain over 2-8 post-operative days before medications. This is quantified using the validated Wong-Baker FACES pain metric. The scale is from 0 to 10 with 10 being worse outcome. Patients receive a take-home pain diary and for 14 days report their maximum pain both before and after taking each pain medication. The mean of the pain ratings prior to taking pain medications from post-operative days 2-8 will be the primary outcome measure.
Interventions
- DRUG Placebo
- DRUG Acetaminophen
- DRUG Ibuprofen
- DRUG Dexamethasone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 222 participants |
| Start Date | 2021-08-05 |
| Est. Completion | 2023-07-11 |
| Phase | Phase 3 |
Why NCT04879823 stopped before completion
NCT04879823 is an interventional study that assigns participants to a tested intervention. The registered 222 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (71% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT04879823 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04879823 about?
NCT04879823 is a clinical study titled "Post-operative Course of Dexamethasone to Reduce Tonsillectomy Morbidity". The goal of this study is determine if an oral systemic course of steroids is a safe and effective option in lowering pain and complications following adenotonsillectomy in various pediatric age groups. A double blind, placebo-controlled randomized clinical trial of steroids (dexamethasone) versus p...
What is the current status of trial NCT04879823?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 222 participants. The study started on 2021-08-05. Estimated completion is 2023-07-11.
What interventions are being tested in trial NCT04879823?
The interventions under investigation include: Placebo (DRUG), Acetaminophen (DRUG), Ibuprofen (DRUG), Dexamethasone (DRUG).
Who is sponsoring clinical trial NCT04879823?
This trial is sponsored by David Chi, MD, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04879823's enrollment target sits among peer trials
222 1317th of 2000 higher than 683 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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