Nurse Reduction of Pulled Elbow
Reduction of Radial Head Subluxation in Children Via a Nurse Initiated Pathway: A Randomized Control Trial
1 other identifier
interventional
245
1 country
1
Brief Summary
Radial head subluxation, also known as pulled elbow or nursemaid's elbow, is one of the most common upper extremity injuries in young children and a common reason for an emergency department visit.1 The injury typically occurs when a forceful longitudinal traction is applied to an extended and pronated forearm.2 Children with radial head subluxation are usually easily recognized by their clinical presentation and rapidly treated by a simple reduction technique involving either hyperpronation or supination and flexion of the injured arm.3-7 Despite the relative ease of diagnosis and treatment, children with radial head subluxation often wait several hours in a pediatric emergency department for a reduction that takes only a few minutes.8 Such visits have direct health care costs and involve time and stress for the child and their family. While many factors are associated with parental and patient satisfaction in the emergency department, it appears that that early treatment or intervention and shorter waiting times correlate with patient and parent satisfaction.9,10 As well, patient satisfaction appears to be the same or better when emergency department care for minor injuries is provided by nurse practitioners compared to physicians.11-13 Increasingly nurse initiated treatments and the use of medical directives and clinical pathways are becoming a focus in providing health care.14-17 While radial head subluxation treatment is an appropriate area to consider management by emergency department nurses, no studies have examined their role in the management of this common injury. Our study's objective was to examine whether triage nurses, trained in the use of a medical directive that taught recognition and treatment of radial head subluxation, could successfully reduce radial head subluxation at a rate similar to physicians. Given the practical constraints at the time of emergency department triage, this study was designed as a cluster randomized trial where the unit of randomization was a day and the patients on any given day were assigned to the nurse or physician arm for the entire day.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 8, 2009
CompletedFirst Posted
Study publicly available on registry
October 14, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedResults Posted
Study results publicly available
December 30, 2014
CompletedDecember 30, 2014
December 1, 2014
1 year
October 8, 2009
November 25, 2014
December 28, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of Patients With Successful Reduction of Radial Head Subluxation by Nurse, Compared With Physician Controls
10-15 minutes post reduction attempt
Secondary Outcomes (3)
Time to Discharge From ED (Minutes)
End of enrollment
Proportion of Patients With Presentation Compatible With RHS, Have Reduction Attempted, Who Are Subsequently Diagnosed With Fracture.
Every 3 months during enrollment
Proportion of Patients With RHS Not Identified by Nurse Pathway.
End of enrollment
Study Arms (2)
Nurse Reduction
EXPERIMENTALPatients randomized to reduction by nurse.
Physician Reduction
ACTIVE COMPARATORPatients randomized to treatment by Emergency Department Physician in traditional ED manner
Interventions
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
Eligibility Criteria
You may qualify if:
- Age up to 6 years
- Physical exam consistent with RHS 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Childrens Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1, Canada
Related Publications (39)
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PMID: 24664649DERIVED
Results Point of Contact
- Title
- Dr Andrew Dixon
- Organization
- University of Alberta
Study Officials
- PRINCIPAL INVESTIGATOR
Andrew C Dixon, MD
University of Alberta
- STUDY DIRECTOR
Amy Plint, MD
University of Ottawa
- STUDY DIRECTOR
Martin Osmond, MD
University of Ottawa
- STUDY DIRECTOR
Nick Barrowman, PhD
University of Ottawa
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
October 8, 2009
First Posted
October 14, 2009
Study Start
October 1, 2009
Primary Completion
October 1, 2010
Study Completion
October 1, 2010
Last Updated
December 30, 2014
Results First Posted
December 30, 2014
Record last verified: 2014-12