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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00652548
Other study ID # 08-0007
Secondary ID IRB #08-0007NHRO
Status Completed
Phase N/A
First received March 28, 2008
Last updated March 29, 2017
Start date March 2008
Est. completion date September 2009

Study information

Verified date March 2017
Source University of Louisville
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date September 2009
Est. primary completion date September 2009
Accepts healthy volunteers No
Gender All
Age group 1 Year to 18 Years
Eligibility 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


Related Conditions & MeSH terms


Locations

Country Name City State
United States Kosair Children's Hospital Louisville Kentucky

Sponsors (1)

Lead Sponsor Collaborator
University of Louisville

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Unblinded real-time bedside US by the ED physician vs. radiographs Single ED visit
Secondary Interoperator reliability between the blinded reviewer and bedside ED physician Single ED visit
Secondary FACES pain score for pain for US vs. radiographs for children = 5 yrs Single ED visit
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