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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 is a Phase 4 study that was terminated before completion, run by Baylor College of Medicine. The registered enrollment target is 29 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05640674
The ClinicalTrials.gov registry entry for NCT05640674 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 29 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Acetaminophen is the first listed.
NCT05640674 reports 0 study locations.
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.
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