Nurse Reduction of Pulled Elbow

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Children's Hospital of Eastern Ontario.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Ontario Ministry of Health and Long Term Care
Information provided by:
Children's Hospital of Eastern Ontario
ClinicalTrials.gov Identifier:
NCT00993954
First received: October 8, 2009
Last updated: October 13, 2009
Last verified: October 2009
  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

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: 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 October 23, 2014