Nurse Reduction of Pulled Elbow - Full Text View

Purpose

Radial head subluxation (RHS), or pulled elbow, is the most common upper extremity injury in young children, accounting for up to 60% of upper extremity emergency department (ED) visits. At CHEO alone there are about 250 cases per year. Children with this injury suffer discomfort and an inability to use their arm. The injury is most commonly caused by a pull on the arm in the course of normal parenting such as dressing or lifting children. The vast majority of these injuries are quickly and easily treated by a simple reduction maneuver which restores normal arm usage within a few minutes with minimal discomfort. However these children often wait several hours in an ED to see a physician. During this time the patient is in pain. Parents, who often have caused the injury, suffer needless concern over having inflicted a serious injury to their child.

This study seeks to reduce time to treatment, by having this injury identified and treated by the triage nurse on arrival. The investigators primary objective is to show that nurses are equivalent to physicians at successfully reducing RHS. Secondarily, the investigators hope to show a reduction in time to normal arm usage of at least 30 minutes. The investigators will also track the accuracy of nurse identification of RHS.

Several centres in Canada and Australia have already implemented such protocols. However there are no studies of their treatment effectiveness or impact on wait times. During the study period, patients will be assigned to either nurse treatment or traditional physician treatment on the basis of their day of presentation. Prior to treatment the nurse will explain the injury, the new protocol and the risks and benefits of the procedure. The family will be informed that they are able to wait for a physician assessment if they prefer. Verbal consent for the procedure will be obtained. As no information will be collected, outside of that needed for any emergency department visit, and no follow-up is planned written consent for participation in the study will not be obtained.

The investigators intend to show this new protocol will decrease the time children are in pain, decrease time of parental stress and help to alleviate emergency wait times. If successful as a study intervention the investigators aim will be to have a standing medical directive in the emergency for the nurse initiated reduction of radial head subluxation.

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

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: At 1 and 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to normal usage (minutes) [ Time Frame: End of enrollment- 2 years ] [ Designated as safety issue: No ]
Time to discharge from ED (minutes) [ Time Frame: End of enrollment- 2 years ] [ 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- 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	224
Study Start Date:	October 2009
Estimated Study Completion Date:	October 2011
Estimated Primary Completion Date:	October 2011 (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

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00993954

Contacts

Contact: Andrew C Dixon, MD	780-752-8353	andrew.dixon@albertahealthservices.ca
Contact: Amy Plint, MD	613-737-7600 ext 3237	plint@cheo.on.ca

Locations

Canada, Ontario
Childrens Hospital of Eastern Ontario	Recruiting
Ottawa, Ontario, Canada, K1H 8L1
Contact: Amy Plint, Medical Doctor 613-737-7600 ext 3237 plint@cheo.on.ca

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

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Responsible Party:	Andrew C Dixon, University of Alberta
ClinicalTrials.gov Identifier:	NCT00993954 History of Changes
Other Study ID Numbers:	08/29x
Study First Received:	October 8, 2009
Last Updated:	October 13, 2009
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 May 19, 2013