NCT00993954

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
245

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2009

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

October 8, 2009

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 14, 2009

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
4.2 years until next milestone

Results Posted

Study results publicly available

December 30, 2014

Completed
Last Updated

December 30, 2014

Status Verified

December 1, 2014

Enrollment Period

1 year

First QC Date

October 8, 2009

Results QC Date

November 25, 2014

Last Update Submit

December 28, 2014

Conditions

Keywords

Nurse TreatmentPulled Elbow

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

EXPERIMENTAL

Patients randomized to reduction by nurse.

Procedure: Reduction of Radial Head Subluxation

Physician Reduction

ACTIVE COMPARATOR

Patients randomized to treatment by Emergency Department Physician in traditional ED manner

Procedure: Reduction of Radial Head Subluxation

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

Nurse ReductionPhysician Reduction

Eligibility Criteria

AgeUp to 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

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

Location

Related Publications (39)

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Results Point of Contact

Title
Dr Andrew Dixon
Organization
University of Alberta

Study Officials

  • Andrew C Dixon, MD

    University of Alberta

    PRINCIPAL INVESTIGATOR
  • Amy Plint, MD

    University of Ottawa

    STUDY DIRECTOR
  • Martin Osmond, MD

    University of Ottawa

    STUDY DIRECTOR
  • Nick Barrowman, PhD

    University of Ottawa

    STUDY DIRECTOR

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

Locations