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The Utilization of Ultrasound to Diagnose Pediatric Elbow Fractures

The Utilization of Ultrasound to Diagnose Pediatric Elbow Fractures: Evaluation of Cost Savings, Radiation Exposure, and Patient Satisfaction

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07212036
Enrollment
225
Registered
2025-10-21
Start date
2025-07-22
Completion date
2027-09-02
Last updated
2026-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Elbow Dislocation, Elbow Pain, Humerus Fractures, Jakob II Classification, Radial Head Fractures, Radial Head or Neck Fractures, Supracondylar Humerus Fracture

Keywords

elbow pain, elbow fracture, supracondylar humerus fracture, pediatric, lateral humeral condyle fracture, radial head fracture, radial neck fracture, monteggia fracture, elbow dislocation, radial head dislocation, emergency department, ultrasound

Brief summary

The goal of this intervention trial is to learn if a ultrasound diagnosis of elbow fractures can improve care in pediatric patients seen in the emergency room. The main questions it aims to answer are: The primary outcomes measured are cost of the emergency visit, radiation exposure, time spent in the emergency department and patient satisfaction. Patients who are evaluated with ultrasounds of the elbow will be compared to patients who have x-rays of the elbow. Participants will be assigned either to the ultrasound group or x-rays group when they present with elbow pain.

Detailed description

The goal of this study is to evaluate whether the use of point-of-care ultrasonography (PoCUS) for elbow trauma evaluation results in less radiation exposure, less cost of treatment and shorter length of stay in Emergency Room (ER) than use of radiography. The study team will use PoCUS to screen for isolated elbow fractures presented to the ER. The researchers will compare cost of treatment both for patients and health care system and length of stay in both the groups. This study will also evaluate whether the use of PoCUS alleviates discomfort to pediatric patients and increases satisfaction of the families as compared to the use of radiography. Family satisfaction surveys and patient pain surveys will act as direct measures of family satisfaction. The study team will use length of stay and cost of treatment as indirect measures of satisfaction. The researchers will compare amount of comfort and satisfaction with and without the use of PoCUS to evaluate the overall patient comfortability and patient satisfaction. The researchers hypothesize that the use of PoCUS will reduce time of emergency department length of stay, radiation exposure, pain or discomfort and cost, and will increase patient's and family satisfaction.

Interventions

DIAGNOSTIC_TESTUltrasound of the elbow

An ultrasound of the elbow obtained of pediatric patients with elbow pain

DIAGNOSTIC_TESTX-ray of elbow

An x-ray of the elbow obtained of pediatric patients with elbow pain

Sponsors

Nemours Children's Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
Yes

Inclusion criteria

• Pediatric patient with elbow pain

Exclusion criteria

* Polytrauma (more than one injury) * Deformity of the arm including the elbow * Pain in any other location than the elbow * Pain in other parts of the same limb including the, wrist, forearm, shoulder, hand * Pain in other limbs, * Puckering of the skin (skin indentation) * Obvious fracture * Open wound at or around the elbow * Pain and swelling without trauma * Concerns for tumor or infection * Suspected nursemaid's elbow

Design outcomes

Primary

MeasureTime frameDescription
Patient SatisfactionDay 1The patient satisfaction scores will be collected by the research assistant using the Emergency Department Consumer Assessment of Healthcare Providers and Systems Survey (ED CAHPS Survey) Version 1.0. The survey will be scored based on the recommended guidelines from CAHPS. Please see the attached scoring guidelines for further information.
cost of treatmentDay 1Cost of treatment: will be based from hospital charges in United States Dollars (USD). The cost will be based off the cash charge for the 3-4 view x-rays of the elbow. This information is readily available online and is currently $652.00 . It would be impossible to base from reimbursement as each insurance provider reimburses at a different rate. No cost will be assigned for the ultrasound as it is a point of care (POC) device that has no charge.

Secondary

MeasureTime frameDescription
Length of StayDay1calculated and recorded in EPIC. The time in minutes will be calculated from from the start when the patient is registered in the ED. All patients are registered and triaged when they enter the ED lobby. The time in ED in Epic is then stopped when the patient is discharged by the nurse.
Pain During Imaging ProcedureDay 1Patient pain scores who are younger than 3 years will be collected by using The FLACC score (for face, legs, activity, cry, concealability) The pain scores will be collected using the Wong-Baker FACES Pain Rating Scale for patients ages equal to and greater than 3 years old.

Countries

United States

Contacts

CONTACTJason Malone, DO
jason.malone@nemours.org407-319-3487
PRINCIPAL_INVESTIGATORJason B Malone, DO

Nemours Children's Health

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026