Post-operative Pain Management in Children With Supracondylar Humerus Fractures (NCT05640674) | Clinical Trial Compass
TerminatedPhase 4
Post-operative Pain Management in Children With Supracondylar Humerus Fractures
Stopped: After reviewing our enrollment numbers and feasibility, we have decided to close the study due to low enrollment.
United States29 participantsStarted 2023-09-12
Plain-language 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.
Who can participate
Age range
3 Years – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Closed, Gartland type III supracondylar humerus fracture
* Fractures treated with closed reduction and percutaneous pinning (CRPP)
* Patients expected to follow up at Texas Children's Hospital
* Patients/guardians must speak English or Spanish
Exclusion Criteria:
* Fractures associated with open skin wounds, polytrauma, neurologic deficit, or vascular deficit
* Patients who have impaired ability to report pain severity such as intellectual delay.
* Patients who have a problem with bone healing such as osteogenesis imperfecta.
* Patients who are unable to take the standard dose of acetaminophen, ibuprofen, or hydrocodone (allergy, severe kidney disease, etc).
* Patients who are on chronic NSAID or opioid medication prior to injury.
* Patients with injury from suspected non-accidental trauma.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Daily Pain Scores on the FACES Scale
Timeframe: from discharge until pain medication is no longer required (assessed up to 3 weeks)