The Utilization of Ultrasound to Diagnose Pediatric Elbow Fractures

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 18
SponsorNemours Children's Clinic

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

225 Participants
are divided into 2 treatment groups
Group A: Patients elbow pain diagnosed with ultrasoundExperimental treatment 1 intervention
Group B: Patient elbow pain diagnosed with x-rayActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Patient Satisfaction

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.

Time frame
Day 1
2

cost of treatment

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.

Time frame
Day 1

Secondary outcomes

1

Length of Stay

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.

Time frame
Day1
2

Pain During Imaging Procedure

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.

Time frame
Day 1

Other outcomes

Sponsors and contacts

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