Use of Ultrasound to Evaluate Clavicle Fractures in Pediatric Patients

Fractures Clinical Trial

Official title:

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

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
• 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)

Related Conditions & MeSH terms

• Fractures
• Fractures, Bone

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