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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: Clinical Trial Phase 1 study, sponsored by David Chi, MD.
NCT04791761 is a Phase 1 study that was terminated before completion, run by David Chi, MD. The registered enrollment target is 73 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (22% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Average pain over 14 post-operative days before and after 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 these pain ratings will be the primary outcome measure.
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 |
Why NCT04791761 stopped before completion
NCT04791761 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 73 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (22% higher).
The record links to 0 conditions, and to 5 interventions - of which Acetaminophen is the first listed.
NCT04791761 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04791761's enrollment target sits among peer trials
73 732nd of 2000 higher than 1,265 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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