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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 is a Phase 4 study that was terminated before completion, run by Duke University. The registered enrollment target is 24 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04541147
The ClinicalTrials.gov registry entry for NCT04541147 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Dexamethasone is the first listed.
NCT04541147 reports 0 study locations.
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.
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