Trial Outcomes & Findings for Nurse Reduction of Pulled Elbow (NCT NCT00993954)

NCT ID: NCT00993954

Last Updated: 2014-12-30

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 245 participants
• Primary outcome timeframe: 10-15 minutes post reduction attempt
• Results posted on: 2014-12-30

Participant Flow

2 Patients in the physician group were incorrectly reduced by the triage nurse 21 patients in the nurse group either had no study form or the nurse did not attempt reduction

Participant milestones

Measure	Nurse Reduction Patients randomized to reduction by nurse. 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	Physician Reduction Patients randomized to treatment by Emergency Department Physician in traditional ED manner 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
Overall Study STARTED	145	123
Overall Study COMPLETED	124	121
Overall Study NOT COMPLETED	21	2

Reasons for withdrawal

Measure	Nurse Reduction Patients randomized to reduction by nurse. 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	Physician Reduction Patients randomized to treatment by Emergency Department Physician in traditional ED manner 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
Overall Study Protocol Violation	21	2

Baseline Characteristics

Nurse Reduction of Pulled Elbow

Baseline characteristics by cohort

Measure	Nurse Reduction n=124 Participants Patients randomized to reduction by nurse. 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	Physician Reduction n=121 Participants Patients randomized to treatment by Emergency Department Physician in traditional ED manner 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	Total n=245 Participants Total of all reporting groups
Age, Continuous	2.4 Years STANDARD_DEVIATION 1.0 • n=93 Participants	2.2 Years STANDARD_DEVIATION 1.1 • n=4 Participants	2.3 Years STANDARD_DEVIATION 1.1 • n=27 Participants
Sex: Female, Male Female	80 Participants n=93 Participants	68 Participants n=4 Participants	148 Participants n=27 Participants
Sex: Female, Male Male	44 Participants n=93 Participants	53 Participants n=4 Participants	97 Participants n=27 Participants
Region of Enrollment Canada	124 participants n=93 Participants	121 participants n=4 Participants	245 participants n=27 Participants
Time from injury	88 Minutes n=93 Participants	103 Minutes n=4 Participants	92 Minutes n=27 Participants
Number of patient with injury from pull mechanism	118 participants n=93 Participants	92 participants n=4 Participants	210 participants n=27 Participants
Number of patients with injury from fall mechanism	5 participants n=93 Participants	19 participants n=4 Participants	24 participants n=27 Participants
Number of patient with injury from other mechanisms	1 participants n=93 Participants	10 participants n=4 Participants	11 participants n=27 Participants

PRIMARY outcome

Timeframe: 10-15 minutes post reduction attempt

Outcome measures

Measure	Nurse Reduction n=124 Participants Patients randomized to reduction by nurse. 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	Physician Reduction n=121 Participants Patients randomized to treatment by Emergency Department Physician in traditional ED manner 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
Proportion of Patients With Successful Reduction of Radial Head Subluxation by Nurse, Compared With Physician Controls	84.7 percentage of patients reduced	96.7 percentage of patients reduced

SECONDARY outcome

Timeframe: End of enrollment

Population: 2 missing data point in the physician group

Outcome measures

Measure	Nurse Reduction n=124 Participants Patients randomized to reduction by nurse. 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	Physician Reduction n=119 Participants Patients randomized to treatment by Emergency Department Physician in traditional ED manner 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
Time to Discharge From ED (Minutes)	50 minutes Interval 32.0 to 82.0	105 minutes Interval 63.0 to 150.0

SECONDARY outcome

Timeframe: Every 3 months during enrollment

Outcome measures

Measure	Nurse Reduction n=124 Participants Patients randomized to reduction by nurse. 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	Physician Reduction n=121 Participants Patients randomized to treatment by Emergency Department Physician in traditional ED manner 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
Proportion of Patients With Presentation Compatible With RHS, Have Reduction Attempted, Who Are Subsequently Diagnosed With Fracture.	1 participants	0 participants

SECONDARY outcome

Timeframe: End of enrollment

Outcome measures

Measure	Nurse Reduction n=145 Participants Patients randomized to reduction by nurse. 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	Physician Reduction Patients randomized to treatment by Emergency Department Physician in traditional ED manner 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
Proportion of Patients With RHS Not Identified by Nurse Pathway.	21 participants	—

Adverse Events

Nurse Reduction

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Physician Reduction

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Nurse Reduction n=145 participants at risk Patients randomized to reduction by nurse. 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	Physician Reduction n=123 participants at risk Patients randomized to reduction by physician Physicians were free to use the reduction method of their choice
Musculoskeletal and connective tissue disorders Reduction attempted, subsequent fracture diagnosis	0.69% 1/145 • Number of events 1	0.00% 0/123

Additional Information

Dr Andrew Dixon

University of Alberta

Phone: 780-492-3553

Email: andrew.dixon@albertahealthservices.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place