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Clinical Trials/NCT00652548
NCT00652548
Completed
Not Applicable

Utility of Bedside Ultrasound to Diagnose Clavicle Fractures in the Pediatric Emergency Department

University of Louisville1 site in 1 country100 target enrollmentMarch 2008
ConditionsFractures

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Fractures
Sponsor
University of Louisville
Enrollment
100
Locations
1
Primary Endpoint
Comparison of a blinded reviewer's interpretation of bedside US images to an attending radiologist's interpretation of radiographs
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2008
End Date
September 2009
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Keith Cross

Assistant Professor

University of Louisville

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Comparison of a blinded reviewer's interpretation of bedside US images to an attending radiologist's interpretation of radiographs

Time Frame: Single visit to emergency department

Secondary Outcomes

  • 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)

Study Sites (1)

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