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NCT04905563 · ClinicalTrials.gov registry record · Phase 4
NSAIDs vs Opioids for Post-op Pain in Supracondylar Humerus Fractures
A Phase 4 study, sponsored by Le Bonheur Children's Hospital.
- Terminated
- Registry status
- Phase 4
- Development phase
- 30
- Enrollment target
NCT04905563: Clinical Trial Phase 4 study, sponsored by Le Bonheur Children's Hospital.
NCT04905563 is a Phase 4 study that was terminated before completion, run by Le Bonheur Children's Hospital. The registered enrollment target is 30 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04905563, a Phase 4 study, was terminated before completion, sponsored by Le Bonheur Children's Hospital.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 30 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if using the combination of acetaminophen (also known as Tylenol) and ibuprofen (also known as Motrin or Advil) will provide equal or better pain control as compared to acetaminophen-hydrocodone (also known as Lortab), in children with broken elbows who need surgery. This study will examine whether the combination of acetaminophen and ibuprofen can provide pain control as well as or better than acetaminophen-hydrocodone so that doctors might be able to prescribe less acetaminophen-hydrocodone (which can be addictive) to children in the future. Currently, the standard of care for pain control following this kind of elbow surgery is acetaminophen-hydrocodone.
Primary Outcome
Pain scores during postoperative hospital stay on a Wong-Baker Faces scale. 0 (No Pain) to 10 (Worst pain).
Interventions
- DRUG Acetaminophen-Hydrocodone
- DRUG Acetaminophen and Ibuprofen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2021-06-07 |
| Est. Completion | 2024-01-05 |
| Phase | Phase 4 |
Why NCT04905563 stopped before completion
NCT04905563 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which Acetaminophen-Hydrocodone is the first listed.
NCT04905563 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04905563 about?
NCT04905563 is a clinical study titled "NSAIDs vs Opioids for Post-op Pain in Supracondylar Humerus Fractures". The purpose of this study is to determine if using the combination of acetaminophen (also known as Tylenol) and ibuprofen (also known as Motrin or Advil) will provide equal or better pain control as compared to acetaminophen-hydrocodone (also known as Lortab), in children with broken elbows who need...
What is the current status of trial NCT04905563?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 30 participants. The study started on 2021-06-07. Estimated completion is 2024-01-05.
What interventions are being tested in trial NCT04905563?
The interventions under investigation include: Acetaminophen-Hydrocodone (DRUG), Acetaminophen and Ibuprofen (DRUG).
Who is sponsoring clinical trial NCT04905563?
This trial is sponsored by Le Bonheur Children's Hospital, which has 14 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04905563's enrollment target sits among peer trials
30 1552nd of 2000 higher than 367 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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