TerminatedPhase 4

NSAIDs vs Opioids for Post-op Pain in Supracondylar Humerus Fractures

Stopped: Clinical evidence supporting the hypothesis of this study has been published

United States30 participantsStarted 2021-06-07

Plain-language 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.

Who can participate

Age range

4 Years – 13 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: * isolated supracondylar humerus fracture * undergoing closed reduction with percutaneous pinning (CRPP) Exclusion Criteria: * Allergies to acetaminophen, ibuprofen, and/or acetaminophen-HYDROcodone * Liver or renal disease * history of bleeding disorder * medical diagnosis of juvenile arthritis * on chronic NSAIDs or Opioids PRIOR to the procedure * medical diagnosis of coagulopathies, open fractures, other injuries at time of diagnosis (multi-system trauma) * vascular compromise and/or compartment syndrome upon admission

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

Pain Scores

Timeframe: 24 hours (duration of post-operative stay)

Trial details

NCT IDNCT04905563

SponsorLe Bonheur Children's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-01-05

Results submitted2024-01-16

View on ClinicalTrials.gov More Supracondylar Humerus Fracture trials