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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

October 8, 2009
October 13, 2009
October 2009
October 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00993954 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Nurse Reduction of Pulled Elbow
Reduction of Radial Head Subluxation in Children Via a Nurse Initiated Pathway: A Randomized Control Trial

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Radial Head Subluxation
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
  • Experimental: Nurse Reduction
    Patients randomized to reduction by nurse.
    Intervention: Procedure: Reduction of Radial Head Subluxation
  • Active Comparator: Physician Reduction
    Patients randomized to treatment by Emergency Department Physician in traditional ED manner
    Intervention: Procedure: Reduction of Radial Head Subluxation

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
224
October 2011
October 2011   (final data collection date for primary outcome measure)

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)
Both
up to 6 Years
No
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
Canada
 
NCT00993954
08/29x
Yes
Andrew C Dixon, University of Alberta
Children's Hospital of Eastern Ontario
Ontario Ministry of Health and Long Term Care
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
Children's Hospital of Eastern Ontario
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP