Nurse Reduction of Pulled Elbow

This study has been completed.
Sponsor:
Collaborator:
Ontario Ministry of Health and Long Term Care
Information provided by (Responsible Party):
Andrew Dixon, University of Alberta
ClinicalTrials.gov Identifier:
NCT00993954
First received: October 8, 2009
Last updated: December 28, 2014
Last verified: December 2014
  Purpose

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.


Condition Intervention
Radial Head Subluxation
Procedure: Reduction of Radial Head Subluxation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Reduction of Radial Head Subluxation in Children Via a Nurse Initiated Pathway: A Randomized Control Trial

Resource links provided by NLM:


Further study details as provided by Children's Hospital of Eastern Ontario:

Primary Outcome Measures:
  • Proportion of Patients With Successful Reduction of Radial Head Subluxation by Nurse, Compared With Physician Controls [ Time Frame: 10-15 minutes post reduction attempt ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to Discharge From ED (Minutes) [ Time Frame: End of enrollment ] [ Designated as safety issue: No ]
  • Proportion of Patients With Presentation Compatible With RHS, Have Reduction Attempted, Who Are Subsequently Diagnosed With Fracture. [ Time Frame: Every 3 months during enrollment ] [ Designated as safety issue: Yes ]
  • Proportion of Patients With RHS Not Identified by Nurse Pathway. [ Time Frame: End of enrollment ] [ Designated as safety issue: No ]

Enrollment: 245
Study Start Date: October 2009
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nurse Reduction
Patients randomized to reduction by nurse.
Procedure: Reduction of Radial Head Subluxation
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
Active Comparator: Physician Reduction
Patients randomized to treatment by Emergency Department Physician in traditional ED manner
Procedure: Reduction of Radial Head Subluxation
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

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)
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00993954

Locations
Canada, Ontario
Childrens Hospital of Eastern Ontario
Ottawa, Ontario, Canada, K1H 8L1
Sponsors and Collaborators
Children's Hospital of Eastern Ontario
Ontario Ministry of Health and Long Term Care
Investigators
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
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Andrew Dixon, Assistant Professor, University of Alberta
ClinicalTrials.gov Identifier: NCT00993954     History of Changes
Other Study ID Numbers: 08/29x
Study First Received: October 8, 2009
Results First Received: November 25, 2014
Last Updated: December 28, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Children's Hospital of Eastern Ontario:
Nurse Treatment
Pulled Elbow

Additional relevant MeSH terms:
Dislocations
Wounds and Injuries

ClinicalTrials.gov processed this record on September 01, 2015