Nurse Reduction of Pulled Elbow
Recruitment status was Recruiting
| Tracking Information | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | October 8, 2009 | ||||||||||||||||
| Last Updated Date | October 13, 2009 | ||||||||||||||||
| Start Date ICMJE | October 2009 | ||||||||||||||||
| Estimated Primary Completion Date | October 2011 (final data collection date for primary outcome measure) | ||||||||||||||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||||||||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||
| Change History | Complete list of historical versions of study NCT00993954 on ClinicalTrials.gov Archive Site | ||||||||||||||||
| Current Secondary Outcome Measures ICMJE |
|
||||||||||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||
| Descriptive Information | |||||||||||||||||
| Brief Title ICMJE | Nurse Reduction of Pulled Elbow | ||||||||||||||||
| Official Title ICMJE | Reduction of Radial Head Subluxation in Children Via a Nurse Initiated Pathway: A Randomized Control Trial | ||||||||||||||||
| Brief Summary | 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. |
||||||||||||||||
| Detailed Description | Not Provided | ||||||||||||||||
| Study Type ICMJE | Interventional | ||||||||||||||||
| Study Phase | Not Provided | ||||||||||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
||||||||||||||||
| Condition ICMJE | Radial Head Subluxation | ||||||||||||||||
| Intervention ICMJE | 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 |
||||||||||||||||
| Study Arm (s) |
|
||||||||||||||||
| Publications * |
|
||||||||||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||||||||||
| Recruitment Information | |||||||||||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||||||||||
| Estimated Enrollment ICMJE | 224 | ||||||||||||||||
| Estimated Completion Date | October 2011 | ||||||||||||||||
| Estimated Primary Completion Date | October 2011 (final data collection date for primary outcome measure) | ||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||||||||||
| Gender | Both | ||||||||||||||||
| Ages | up to 6 Years | ||||||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||||||
| Contacts ICMJE |
|
||||||||||||||||
| Location Countries ICMJE | Canada | ||||||||||||||||
| Administrative Information | |||||||||||||||||
| NCT Number ICMJE | NCT00993954 | ||||||||||||||||
| Other Study ID Numbers ICMJE | 08/29x | ||||||||||||||||
| Has Data Monitoring Committee | Yes | ||||||||||||||||
| Responsible Party | Andrew C Dixon, University of Alberta | ||||||||||||||||
| Study Sponsor ICMJE | Children's Hospital of Eastern Ontario | ||||||||||||||||
| Collaborators ICMJE | Ontario Ministry of Health and Long Term Care | ||||||||||||||||
| Investigators ICMJE |
|
||||||||||||||||
| Information Provided By | Children's Hospital of Eastern Ontario | ||||||||||||||||
| Verification Date | October 2009 | ||||||||||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||||||||||