Use of Ultrasound to Evaluate Clavicle Fractures in Pediatric Patients
Completed
- Conditions
- Fractures
- Registration Number
- NCT00652548
- Lead Sponsor
- University of Louisville
- Brief Summary
This studies investigates the hypothesis that bedside ultrasound is as accurate as plain x-rays for diagnosing clavicle fractures in children in a pediatric emergency department. Children with shoulder injuries are enrolled and receive both an ultrasound imaging (experimental) and x-rays (standard-of-care) to see if ultrasound has the same (or better)accuracy, with less cost, time, and radiation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
- Age 1-18 years
- Pain from recent shoulder/clavicle injury
- Intact neurovascular exam
- Radiographs performed as part of normal ED evaluation
Exclusion Criteria
- Hemodynamic instability
- Multisystem trauma
- Altered mental status
- Open wounds to injured shoulder
- Developmental delay
- Prior radiographs at another clinic/hospital for this injury
- Previous clavicle fracture on the affected side
- Ultrasound gel allergy
- Non-English-speaking parents/child (unable to give informed consent)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparison of a blinded reviewer's interpretation of bedside US images to an attending radiologist's interpretation of radiographs Single visit to emergency department
- Secondary Outcome Measures
Name Time Method Interoperator reliability between the blinded reviewer and bedside ED physician Single ED visit FACES pain score for pain for US vs. radiographs for children ≥ 5 yrs Single ED visit Unblinded real-time bedside US by the ED physician vs. radiographs Single ED visit
Trial Locations
- Locations (1)
Kosair Children's Hospital
🇺🇸Louisville, Kentucky, United States