Use of Ultrasound to Evaluate Clavicle Fractures in Pediatric Patients

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.

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Key information

Conditions

Fractures Fractures, Bone Wounds and Injuries

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kosair Children's Hospital

Louisville, Kentucky, 40202, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Unblinded real-time bedside US by the ED physician vs. radiographs

Time frame: Single ED visit
Interoperator reliability between the blinded reviewer and bedside ED physician

Time frame: Single ED visit
FACES pain score for pain for US vs. radiographs for children ≥ 5 yrs

Time frame: Single ED visit

Sponsors and collaborators

Lead sponsor

University of Louisville

Other

Registry information

Official study title

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

Important dates

Study start: 2008
Primary completion: 2009
Study completion: 2009
First posted: Apr 3, 2008
Registry last updated: Mar 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed