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NCT04541147 · ClinicalTrials.gov registry record · Phase 4
Opioid & Steroid Use Following Tonsillectomy in Pediatric Patients
A Phase 4 study, sponsored by Duke University.
- Terminated
- Registry status
- Phase 4
- Development phase
- 24
- Enrollment target
NCT04541147: Clinical Trial Phase 4 study, sponsored by Duke University.
NCT04541147 is a Phase 4 study that was terminated before completion, run by Duke University. The registered enrollment target is 24 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04541147, a Phase 4 study, was terminated before completion, sponsored by Duke University.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 24 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if a post-operative course of oral dexamethasone affects opioid usage in pediatric patients undergoing tonsillectomy. Patients who are scheduled to undergo tonsillectomy or adenotonsillectomy are randomized to receive either 1) a post-operative steroid course of oral dexamethasone in addition opioids, acetaminophen,NSAIDs or 2) opioids/acetaminophen/NSAIDS alone. All drugs are prescribed per approved FDA labeling. Children between the ages of 4-17 will be considered for enrollment. Participants (or with the aid of parents/legal guardian for subjects unable to complete on their own) will complete a diary twice a day to record pain medication administration and visual pain scale. Remaining steroid and opioid medication will be measured at the routine post-operative appointment that occurs 4 - 6 weeks following surgery.
Primary Outcome
Measured by medication log and units remaining.
Interventions
- DRUG Dexamethasone
- DRUG Analgesics
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2021-04-14 |
| Est. Completion | 2023-12-26 |
| Phase | Phase 4 |
Why NCT04541147 stopped before completion
NCT04541147 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Dexamethasone is the first listed.
NCT04541147 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04541147 about?
NCT04541147 is a clinical study titled "Opioid & Steroid Use Following Tonsillectomy in Pediatric Patients". The purpose of this study is to determine if a post-operative course of oral dexamethasone affects opioid usage in pediatric patients undergoing tonsillectomy. Patients who are scheduled to undergo tonsillectomy or adenotonsillectomy are randomized to receive either 1) a post-operative steroid cour...
What is the current status of trial NCT04541147?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 24 participants. The study started on 2021-04-14. Estimated completion is 2023-12-26.
What interventions are being tested in trial NCT04541147?
The interventions under investigation include: Dexamethasone (DRUG), Analgesics (DRUG).
Who is sponsoring clinical trial NCT04541147?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04541147's enrollment target sits among peer trials
24 1699th of 2000 higher than 276 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
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