Supracondylar Humerus FracturePhase 4NCT05640674

Post-operative Pain Management in Children With Supracondylar Humerus Fractures

A Phase 4 study testing Ibuprofen, Hydrocodone/acetaminophen and Acetaminophen in people with Supracondylar Humerus Fracture, run by Baylor College of Medicine at 3 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 3 to 12 years
Conditions the study is for: Supracondylar Humerus Fracture
What is being tested?: Ibuprofen, Hydrocodone/acetaminophen and Acetaminophen
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 29 participants
Where: 3 sitesUnited States
Study dates: 12 Sep 2023to 15 Dec 2025
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 3 to 12 years
All sexes
No healthy volunteers
Child

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Texas Children's Hospital - Main Campus
Houston, Texas, 77030
Texas Children's Hospital - West Campus
Houston, Texas, 77094
Texas Children's Hospital - Woodlands Campus
Houston, Texas, 77384

Other trials in United States

About this study

Official title: A Randomized Controlled Trial of Opioid vs Non-Opioid Postoperative 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 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.

Read the detailed description

Prior to surgery, participants will be randomly assigned to a group that will determine whether they are prescribed an opioid vs non-opioid pain management plan at discharge. Each participants' parent or guardian will be given a journal to keep track of their child's pain severity and the pain medications taken. The journal will updated daily until participants no longer require pain medication. Participants will follow up with their surgeon per usual at their post-operative visits.

Conditions: Supracondylar Humerus Fracture
Being tested: Ibuprofen, Hydrocodone/acetaminophen, Acetaminophen

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IbuprofenDrug
Also called Motrin, Advil
Non-opioid
Hydrocodone/acetaminophenDrug
Also called Hycet
Opioid
AcetaminophenDrug
Also called Tylenol
Non-opioid

Study groups in NCT05640674
Study group	Role	What they receive
Opioid Pain Management	Active comparator	Ibuprofen (liquid, 10mg/kg/dose every 6 hours) will be the first line pain medication and Hydrocodone/Acetaminophen (liquid, 0.135mg Hydrocodone/kg/dose every 6 hours) will be used as needed for breakthrough pain. Receives: Drug: Ibuprofen; Drug: Hydrocodone/acetaminophen
Non-Opioid Pain Management	Experimental	Ibuprofen (liquid, 10mg/kg/dose every 6 hours) will be the first line pain medication and Acetaminophen (liquid, 15mg/kg/dose every 6 hours) will be used as needed for breakthrough pain. Receives: Drug: Ibuprofen; Drug: Acetaminophen

What is being measured

The primary outcome is the main question the study is designed to answer.

Daily Pain Scores on the FACES Scale
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).
Measured: from discharge until pain medication is no longer required (assessed up to 3 weeks)

Secondary outcomes (2)

Number of Days Pain Medication Required
A parent/guardian will record the doses of pain medications given to the participant each day.
Measured: from discharge until pain medication is no longer required (assessed up to 3 weeks)
Number of Pain Medication Doses Required Per Day
A parent/guardian will record the doses of pain medications given to the participant each day.
Measured: from discharge until pain medication is no longer required (assessed up to 3 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Sep 202315 Dec 2025

First posted7 Dec 2022
Study start12 Sep 2023
Primary completion15 Dec 2025
Study completion15 Dec 2025

Why it stopped: After reviewing our enrollment numbers and feasibility, we have decided to close the study due to low enrollment.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Supracondylar Humerus FractureStudies of the same condition, open and under way.
More trials run by Baylor College of MedicineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 29 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05640674
Sponsor's protocol ID: 52475
Status last verified: Jan 2026
First submitted: 29 Nov 2022
Last updated: 10 Feb 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitation
Anxiety Surrounding Supracondylar Pin Removal in Children: A Randomized Controlled Trial
Supracondylar Humerus Fracture, Anxiety
Not yet recruiting
Conservative Versus Surgical Treatment of Gartland Type II Supracondylar Humeral Fractures in Children - Which One ?
Humeral Fractures
RecruitingObservational study
EASY Algorithm Trial (Elbow Trauma Assessment Using Sonography in Children and Youth) Diagnostic Accuracy and Safety of Point-of-care Ultrasound as a Screening Tool for Suspected Elbow Fractures in Children Aged 5 to 15 Years: a Multicenter Prospective Cohort Study
Elbow Fractures, Distal Humerus Fracture
RecruitingPhase 4
Supracondylar Post-Operative Pain Study
Supracondylar Humerus Fracture
Not yet recruiting
Management of Vascular Complications in Pediatric Supracondylar Humerus Fractures
Vascular Complications, Supracondylar Humerus Fracture

All Supracondylar Humerus Fracture trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Controlled Trial of Opioid vs Non-Opioid Postoperative Pain Management in Children With Supracondylar Humerus Fractures
ClinicalTrials.gov ID: NCT05640674
Acronym / sponsor ID: 52475
Conditions: Supracondylar Humerus Fracture
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: After reviewing our enrollment numbers and feasibility, we have decided to close the study due to low enrollment.
Enrolment: 29 participants (actual)
Lead sponsor: Baylor College of MedicineUniversity, hospital or other
Study start: 12 Sep 2023 (actual)
Primary completion: 15 Dec 2025 (actual)
Study completion: 15 Dec 2025 (actual)
First posted: 7 Dec 2022 (actual)
Results: Posted 10 Feb 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Opioid Pain Management	Active comparator	Drug: Ibuprofen, Drug: Hydrocodone/acetaminophenIbuprofen (liquid, 10mg/kg/dose every 6 hours) will be the first line pain medication and Hydrocodone/Acetaminophen (liquid, 0.135mg Hydrocodone/kg/dose every 6 hours) will be used as needed for breakthrough pain.
Non-Opioid Pain Management	Experimental	Drug: Ibuprofen, Drug: AcetaminophenIbuprofen (liquid, 10mg/kg/dose every 6 hours) will be the first line pain medication and Acetaminophen (liquid, 15mg/kg/dose every 6 hours) will be used as needed for breakthrough pain.

Who may qualify

Ages: 3 to 12 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

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

Key exclusion criteria (6 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
IbuprofenAlso: Motrin, AdvilNon-opioid	Drug	Non-Opioid Pain Management, Opioid Pain Management
Hydrocodone/acetaminophenAlso: HycetOpioid	Drug	Opioid Pain Management
AcetaminophenAlso: TylenolNon-opioid	Drug	Non-Opioid Pain Management

Primary outcome

Daily Pain Scores on the FACES Scale
Time frame: from discharge until pain medication is no longer required (assessed up to 3 weeks)
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).

2 secondary outcomes

Number of Days Pain Medication Required
Time frame: from discharge until pain medication is no longer required (assessed up to 3 weeks)
Number of Pain Medication Doses Required Per Day
Time frame: from discharge until pain medication is no longer required (assessed up to 3 weeks)

Results and safety

Results posted to the registry on 10 Feb 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Opioid Pain Management	14	8
Non-Opioid Pain Management	15	5

Primary outcome: Daily Pain Scores on the FACES Scale

Time frame: from discharge until pain medication is no longer required (assessed up to 3 weeks). Mean (Standard Deviation). Unit: scores on a scale/day

Measure	Opioid Pain Management n = 8	Non-Opioid Pain Management n = 5
Value	2.7 (3.0)	1.31 (1.9)

Population analysed: Only 8 opioid and 5 non-opioid patients completed the pain journal, so they are the only patients who could be analyzed.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From enrollment until end of follow-up, up to 4 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Opioid Pain Management	0 of 14 (0%)	0 of 14 (0%)	0 of 14
Non-Opioid Pain Management	0 of 15 (0%)	0 of 15 (0%)	0 of 15

Limitations and caveats (from the sponsor): The study was terminated early due to insufficient enrollment, resulting in inadequate data to meaningfully assess the primary outcome.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Supracondylar Humerus Fracture

Enrolling by invitation
Anxiety Surrounding Supracondylar Pin Removal in Children: A Randomized Controlled Trial
Supracondylar Humerus Fracture, Anxiety
Not yet recruiting
Conservative Versus Surgical Treatment of Gartland Type II Supracondylar Humeral Fractures in Children - Which One ?
Humeral Fractures
RecruitingObservational study
EASY Algorithm Trial (Elbow Trauma Assessment Using Sonography in Children and Youth) Diagnostic Accuracy and Safety of Point-of-care Ultrasound as a Screening Tool for Suspected Elbow Fractures in Children Aged 5 to 15 Years: a Multicenter Prospective Cohort Study
Elbow Fractures, Distal Humerus Fracture
RecruitingPhase 4
Supracondylar Post-Operative Pain Study
Supracondylar Humerus Fracture
Not yet recruiting
Management of Vascular Complications in Pediatric Supracondylar Humerus Fractures
Vascular Complications, Supracondylar Humerus Fracture

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Scott Rosenfeld, MD principal investigator

Baylor College of Medicine

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ibuprofen, Hydrocodone/acetaminophen and Acetaminophen in people with Supracondylar Humerus Fracture, run by Baylor College of Medicine at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Daily Pain Scores on the FACES Scale (time frame: from discharge until pain medication is no longer required (assessed up to 3 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05640674.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.