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NCT05640674 · ClinicalTrials.gov registry record · Phase 4
Post-operative Pain Management in Children With Supracondylar Humerus Fractures
A Phase 4 study, sponsored by Baylor College of Medicine.
- Terminated
- Registry status
- Phase 4
- Development phase
- 29
- Enrollment target
NCT05640674: Clinical Trial Phase 4 study, sponsored by Baylor College of Medicine.
NCT05640674 is a Phase 4 study that was terminated before completion, run by Baylor College of Medicine. The registered enrollment target is 29 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
NCT05640674, a Phase 4 study, was terminated before completion, sponsored by Baylor College of Medicine.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 29 participants
- Enrollment target
Study Summary
There are two common and concurrently used strategies for pain management following surgical treatment of supracondylar humerus (elbow) fractures in children: opioids vs over the counter pain medications. The purpose of this study is to determine if ibuprofen and acetaminophen can provide similar or better pain relief compared to ibuprofen and hydrocodone/acetaminophen (also known as Hycet) for this population of children after they have been discharged. If over the counter medications can provide adequate pain relief, then fewer opioid prescriptions would be necessary. This reduces early opioid exposure and decreases unnecessary opioids in circulation.
Primary Outcome
A parent/guardian will ask participants to rate their pain severity using the Wong-Baker FACES scale, which ranges from 0 (no pain) to 10 (worst pain).
Interventions
- DRUG Acetaminophen
- DRUG Ibuprofen
- DRUG Hydrocodone/acetaminophen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2023-09-12 |
| Est. Completion | 2025-12-15 |
| Phase | Phase 4 |
Why NCT05640674 stopped before completion
NCT05640674 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 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 3 interventions - of which Acetaminophen is the first listed.
NCT05640674 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05640674 about?
NCT05640674 is a clinical study titled "Post-operative Pain Management in Children With Supracondylar Humerus Fractures". There are two common and concurrently used strategies for pain management following surgical treatment of supracondylar humerus (elbow) fractures in children: opioids vs over the counter pain medications. The purpose of this study is to determine if ibuprofen and acetaminophen can provide similar or...
What is the current status of trial NCT05640674?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 29 participants. The study started on 2023-09-12. Estimated completion is 2025-12-15.
What interventions are being tested in trial NCT05640674?
The interventions under investigation include: Acetaminophen (DRUG), Ibuprofen (DRUG), Hydrocodone/acetaminophen (DRUG).
Who is sponsoring clinical trial NCT05640674?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05640674's enrollment target sits among peer trials
29 1634th of 2000 higher than 366 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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