The Utilization of Ultrasound to Diagnose Pediatric Elbow Fractures

Nemours Children's Health

Status: Enrolling

Conditions: Radial Head Fractures; Supracondylar Humerus Fracture; Elbow Dislocation; Humerus Fractures; Elbow Pain; Radial Head or Neck Fractures; Jakob II Classification

Treatments: Diagnostic Test: X-ray of elbow; Diagnostic Test: Ultrasound of the elbow

Study type: Interventional

Funder types: Other

Identifiers

NCT07212036

2051060

Details and patient eligibility

About

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.

Full 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.

Enrollment: 225 estimated patients

Sex: All

Ages: Under 18 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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225 participants in 2 patient groups

Patients elbow pain diagnosed with ultrasound

Experimental group

Description:

Patients with elbow pain will receive an ultrasound of the elbow to evaluate for the present of an elbow fractures, hemarthrosis and/or lipohemarthrosis

Treatment:

Diagnostic Test: Ultrasound of the elbow

Patient elbow pain diagnosed with x-ray

Active Comparator group

Description:

Patients with elbow pain will review a standard two view elbow x-ray (anterior- posterior and lateral) to evaluate for a fracture around the elbow and/or hemarthrosis.

Treatment:

Diagnostic Test: X-ray of elbow