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Evaluating the use of bedside ultrasound versus x-ray to diagnose forearm fractures in children; a randomised trial

Bedside Ultrasound Conducted in Kids with distal upper Limb fractures in the Emergency Department; an open diagnostic randomised-controlled trial and health economic analysis. (BUCKLED RCT)

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12620000637943
Acronym
BUCKLED RCT
Enrollment
270
Registered
2020-05-29
Start date
2020-09-01
Completion date
2021-11-11
Last updated
2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Children frequently present to the emergency department with forearm injuries and often have an x-ray to assess if there is a fracture. Due to the soft and plastic nature of the bones in young children, injuries can cause their bones to bend, known as a buckle fracture. Bedside ultrasound is a test that emergency practitioners can use to rapidly diagnose a fracture at the time of examination, without exposing children to ionising radiation. Ultrasound in this setting is well tolerated, only requiring light touch and gentle manipulation of the forearm and has similar accuracy when compared with x-rays for diagnosing children’s forearm fractures. This is the first trial to assess whether an x-ray is unnecessary when there is either a buckle fracture or no fracture seen on a portable ultrasound machine. This is important as they can be treated at the time of review without any further delay and will avoid these children being exposed to ionising radiation. Children will be randomised to receive either an ultrasound or x-ray for their forearm injury. Both groups will be followed up to see whether there are any differences in their recovery and to determine any complications. We will also determine the time and cost implications of this new approach, which could enable families to go home earlier and could be more cost-effective, with less x-rays being ordered. It is hypothesised that ultrasound is non-inferior to x-ray imaging for the diagnosis of paediatric distal forearm fractures and that it is cost-effective.

Interventions

Eligible patients will be randomised to either bedside ultrasound, otherwise known as point-of-care ultrasound (POCUS), or x-ray imaging as the initial diagnostic approach. POCUS Intervention: POCUS will be performed by a health practitioner (nurse, doctor, allied health professional) who has undergone training and credentialing. This will involve application of gel on the affected forearm which is then interrogated with a high frequency linear probe for up to 10 minutes, using a 6-view protoc

Eligible patients will be randomised to either bedside ultrasound, otherwise known as point-of-care ultrasound (POCUS), or x-ray imaging as the initial diagnostic approach. POCUS Intervention: POCUS will be performed by a health practitioner (nurse, doctor, allied health professional) who has undergone training and credentialing. This will involve application of gel on the affected forearm which is then interrogated with a high frequency linear probe for up to 10 minutes, using a 6-view protocol for evaluation of signs of a fracture. Patients' fractures will be classified into 3 groups: 'no' fracture, 'buckle' fracture or 'other' fracture (i.e. cortical breach fracture, including incomplete, complete or physeal; bow deformity and fractures at other sites will also be included in this group). Both the radius and ulna bones will be individually classified, with the overall forearm classification based on the overarching fracture that determined the management of the patient. If a cortical breach or other signs of a cortical breach (e.g. periosteal haematoma) are identified on POCUS, they will receive an x-ray. 'Pain out of proportion' on physical examination, despite the findings on POCUS, will also mandate an x-ray. This will include patients who have uncontrolled pain, ongoing tenderness or reduced function despite adequate analgesia and is not felt to be in keeping with a soft tissue injury, as per treating clinician judgement. If either 'no' fracture or a 'buckle' fracture are identified on POCUS, they will not receive an x-ray prior to discharge. POCUS images will be later reviewed for correct interpretations. All patients who are diagnosed with either a 'buckle' fracture or 'no' fracture will be given a tentative appointment for ED clinical review in 1 week (5-7 day convenience window).

Sponsors

Gold Coast University Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Diagnosis
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
5 Years to 15 Years
Healthy volunteers
No

Inclusion criteria

• Children aged 5-15 years presenting to the ED • Isolated, non-angulated distal third forearm injury being evaluated for suspected fracture

Exclusion criteria

• Injury sustained >48 hour at time of ED presentation • External imaging has already been performed • Known metabolic bone disease, such as osteogenesis imperfecta • Suspicion of non-accidental injury • Congenital bone malformation, such as radius hypoplasia • Compound fracture • Neurovascular compromise • Distracting injury (e.g. elbow) • Suspicion for hand fracture (e.g. scaphoid) • Inability to perform an accurate clinical assessment e.g. severe developmental delay or behavioural difficulties • Inability to perform ultrasound due to unavailability of a credentialed practitioner • Inability to obtain informed consent from parent

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 23, 2026