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NCT Number: NCT07212036

The Utilization of Ultrasound to Diagnose Pediatric Elbow Fractures

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound of the elbow

Diagnostic Test

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

X-ray of elbow

Diagnostic Test

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

Primary outcomes

  1. Patient Satisfaction

    Time frame: Day 1

    The 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.

  2. cost of treatment

    Time frame: Day 1

    Cost 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 outcomes

  1. Length of Stay

    Time frame: Day1

    calculated 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.

  2. Pain During Imaging Procedure

    Time frame: Day 1

    Patient 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jason Malone, DO

CONTACT

[email protected]

407-319-3487

Sponsors and collaborators

Lead sponsor

Nemours Children's Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 21, 2025
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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