Use of Ultrasound to Evaluate Clavicle Fractures in Pediatric Patients

This study has been completed.
Sponsor:
Information provided by:
University of Louisville
ClinicalTrials.gov Identifier:
NCT00652548
First received: March 28, 2008
Last updated: January 12, 2010
Last verified: March 2008
  Purpose

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
Fractures

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Utility of Bedside Ultrasound to Diagnose Clavicle Fractures in the Pediatric Emergency Department

Resource links provided by NLM:


Further study details as provided by University of Louisville:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Unblinded real-time bedside US by the ED physician vs. radiographs [ Time Frame: Single ED visit ] [ Designated as safety issue: No ]
  • Interoperator reliability between the blinded reviewer and bedside ED physician [ Time Frame: Single ED visit ] [ Designated as safety issue: No ]
  • FACES pain score for pain for US vs. radiographs for children ≥ 5 yrs [ Time Frame: Single ED visit ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: March 2008
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   1 Year to 18 Years
Genders Eligible for Study:   Both
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.

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00652548

Locations
United States, Kentucky
Kosair Children's Hospital
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
University of Louisville
Investigators
Principal Investigator: Keith P Cross, MD University of Louisville
  More Information

No publications provided

Responsible Party: Keith Cross, Kosair Children's Hospital, Dept. of Pediatrics, Division of Emergency Medicine
ClinicalTrials.gov Identifier: NCT00652548     History of Changes
Other Study ID Numbers: 08-0007, IRB #08-0007, NHRO #1310
Study First Received: March 28, 2008
Last Updated: January 12, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Louisville:
Clavicle
Fracture
Ultrasound
Radiation

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on April 17, 2014