NCT00993954

Trial name or title	Reduction of radial head subluxation in children via a nurse initiated pathway: A randomized control trial
Methods	Randomised trial with no assessor blinding
Participants	Inclusion criteria: Aged up to 6 years, physical exam consistent with radial head subluxation which includes not using the affected limb, holding the elbow in extension or slight flexion, forearm in pronation, and patient is distressed only on elbow movement, injury within preceding 12 hours. Exclusion criteria: Deformity of clavicle or arm, swelling of elbow or wrist, significant tenderness on palpation of arm, metabolic bone disease (i.e. osteogenesis imperfecta, neuromuscular disorder that excludes adequate assessment (i.e. severe cerebral palsy).
Interventions	Patients randomised to reduction by nurse or to treatment by Emergency Department (ED) Physician in traditional ED manner. Nurse group will use hyperpronation with extension for first attempt and supination and flexion for second attempt. Physician controls will use either method at their discretion.
Outcomes	Primary outcome measure: Proportion of patients with successful reduction of radial head subluxation by nurse, compared with physician controls Secondary outcome measures: Time to normal usage (minutes). Time to discharge from ED (minutes). Proportion of patients with presentation compatible with radial head subluxation, have reduction attempted, who are subsequently diagnosed with fracture. Proportion of patients with radial head subluxation not identified by nurse pathway.
Starting date	October 2009
Contact information	Andrew Dixon andrew.dixon@albertahealthservices.ca Amy Plint plint@cheo.on.ca
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