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NCT03618823 · ClinicalTrials.gov registry record · Phase 1
Non-opioids for Analgesia After Adenotonsillectomy in Children
A Phase 1 study, sponsored by David Chi, MD.
- Terminated
- Registry status
- Phase 1
- Development phase
- 268
- Enrollment target
NCT03618823: Clinical Trial Phase 1 study, sponsored by David Chi, MD.
NCT03618823 is a Phase 1 study that was terminated before completion, run by David Chi, MD. The registered enrollment target is 268 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (347% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03618823, a Phase 1 study, was terminated before completion, sponsored by David Chi, MD.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 268 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 adenotonsillectomy surgery in children. The investigators will be 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 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. Patients receive a take-home pain diary and for 14 days report their maximum pain both before and after taking pain medication. The mean of these pain ratings will be the primary outcome measure. The Wong-Baker FACES scale is from 0 (min) to 10 (max). A higher score indicates worse outcome/pain.
Interventions
- DRUG Acetaminophen
- DRUG Ibuprofen
- DRUG Oxycodone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 268 participants |
| Start Date | 2018-10-25 |
| Est. Completion | 2020-05-18 |
| Phase | Phase 1 |
Why NCT03618823 stopped before completion
NCT03618823 is an interventional study that assigns participants to a tested intervention. The registered 268 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (347% higher).
The record links to 0 conditions, and to 3 interventions - of which Acetaminophen is the first listed.
NCT03618823 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03618823 about?
NCT03618823 is a clinical study titled "Non-opioids for Analgesia After Adenotonsillectomy in Children". The goal of this study is to determine if non-opioid pain control is a safe way to manage pain after adenotonsillectomy surgery in children. The investigators will be randomly assigning children aged 3-17 to one of two groups: one group will receive non-opioid pain medication only, and the other gro...
What is the current status of trial NCT03618823?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 268 participants. The study started on 2018-10-25. Estimated completion is 2020-05-18.
What interventions are being tested in trial NCT03618823?
The interventions under investigation include: Acetaminophen (DRUG), Ibuprofen (DRUG), Oxycodone (DRUG).
Who is sponsoring clinical trial NCT03618823?
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 NCT03618823's enrollment target sits among peer trials
268 154th of 2000 higher than 1,847 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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