Can a simple painkiller combo replace opioids for kids after elbow surgery?
NCT ID NCT03759028
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether giving children acetaminophen (Tylenol) with ibuprofen (Advil) works as well as acetaminophen with oxycodone for pain after elbow fracture surgery. About 90 children with a specific type of elbow fracture will be randomly assigned to one of the two combinations. Parents and doctors won't know which study drug the child receives. The goal is to see if the non-opioid option controls pain just as well, which could reduce the use of narcotics in children.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 90 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2019
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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4 to 12 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Closed supracondylar humerus fracture * Isolated supracondylar humerus fracture * Type II and III supracondylar humerus fracture * Fractures treated with closed reduction percutaneous pinning Exclusion Criteria: * Fractures with concomitant vascular injury * Fractures with concomitant neurologic deficit * Pathologic fractures * Fractures with concomitant injuries (multiple trauma) * Fractures with swelling requiring post-operative hospitalization for monitoring * Known history of allergies to acetaminophen, ibuprofen or oxycodone * Patients with developmental delay that would preclude participation in the visual analog Faces Pain Scale-Revised * Patients with intellectual disability that would preclude participation in the visual analog Faces Pain Scale-Revised * History of suspected child abuse
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Orthopaedic Institute for Children
RECRUITINGLos Angeles, California, 90007, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Ultrasound might replace X-Rays for Kids' elbow injuries
- Can Over-the-Counter meds replace opioids for Kids' elbow pain?
- Study tests if safer painkillers can replace opioids for Kids' broken elbows
- Ultrasound may slash radiation and costs for Kids' elbow breaks