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Use of Ultrasound to Evaluate Clavicle Fractures in Pediatric Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00652548
Recruitment Status : Completed
First Posted : April 3, 2008
Last Update Posted : March 31, 2017
Information provided by (Responsible Party):
Keith Cross, 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.

Condition or disease

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Utility of Bedside Ultrasound to Diagnose Clavicle Fractures in the Pediatric Emergency Department
Study Start Date : March 2008
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures Ultrasound

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Unblinded real-time bedside US by the ED physician vs. radiographs [ Time Frame: Single ED visit ]
  2. Interoperator reliability between the blinded reviewer and bedside ED physician [ Time Frame: Single ED visit ]
  3. FACES pain score for pain for US vs. radiographs for children ≥ 5 yrs [ Time Frame: Single ED visit ]

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children age 1-18 years presenting to a tertiary center pediatric emergency department complaining of recent traumatic shoulder injury.

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00652548

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United States, Kentucky
Kosair Children's Hospital
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
University of Louisville
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Principal Investigator: Keith P Cross, MD University of Louisville
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Responsible Party: Keith Cross, Assistant Professor, University of Louisville Identifier: NCT00652548    
Other Study ID Numbers: 08-0007
IRB #08-0007
NHRO #1310
First Posted: April 3, 2008    Key Record Dates
Last Update Posted: March 31, 2017
Last Verified: March 2017
Keywords provided by Keith Cross, University of Louisville:
Additional relevant MeSH terms:
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Fractures, Bone
Wounds and Injuries