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NCT04791761 · ClinicalTrials.gov registry record · Phase 1
Non-Opioid Pain Medications After Intracapsular Adenotonsillectomy
A Phase 1 study, sponsored by David Chi, MD.
- Terminated
- Registry status
- Phase 1
- Development phase
- 73
- Enrollment target
NCT04791761 is a Phase 1 study that was terminated before completion, run by David Chi, MD. The registered enrollment target is 73 participants.
The verdict
NCT04791761, a Phase 1 study, was terminated before completion, sponsored by David Chi, MD.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 73 participants
- Enrollment target
Study Summary
The goal of this study is to determine if non-opioid pain control is a safe way to manage pain after intracapsular adenotonsillectomy surgery in children. This study is the second part of our randomized clinical trials of assessing pain after adenotonsillectomy (T\&A), the first being total T\&A. The investigators will repeat the methodology in the first clinical trial by randomly assigning children aged 3-17 to one of two groups: one group will receive non-opioid pain medication only, and the other group will receive opioid and non-opioid medications for pain control. The investigators will analyze the data and determine if there is a difference in pain control between the two drug regimens, and if there are any other associated complications between the two groups. This study is important because if we can demonstrate that there is little difference in outcomes and pain control between the two groups, a strong argument can be made for reducing or eliminating opioid prescription after intracapsular adenotonsillectomy. This may protect future children from the risks of taking opioid medications and help to reduce the scope of the opioid epidemic.
Interventions
- DRUG Acetaminophen
- DRUG Ibuprofen
- DRUG Oxycodone
- OTHER Opioid disposal pouch
- OTHER Opioid disposal education
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 73 participants |
| Start Date | 2021-04-13 |
| Est. Completion | 2023-07-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04791761
The ClinicalTrials.gov registry entry for NCT04791761 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 73 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is David Chi, MD, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Acetaminophen is the first listed.
NCT04791761 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04791761 about?
NCT04791761 is a clinical study titled "Non-Opioid Pain Medications After Intracapsular Adenotonsillectomy". The goal of this study is to determine if non-opioid pain control is a safe way to manage pain after intracapsular adenotonsillectomy surgery in children. This study is the second part of our randomized clinical trials of assessing pain after adenotonsillectomy (T\&A), the first being total T\&A. Th...
What is the current status of trial NCT04791761?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 73 participants. The study started on 2021-04-13. Estimated completion is 2023-07-03.
What interventions are being tested in trial NCT04791761?
The interventions under investigation include: Acetaminophen (DRUG), Ibuprofen (DRUG), Oxycodone (DRUG), Opioid disposal pouch (OTHER), Opioid disposal education (OTHER).
Who is sponsoring clinical trial NCT04791761?
This trial is sponsored by David Chi, MD, which has 4 total clinical trials registered on ClinicalTrials.gov.
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