Make up for the Epinephrine Autoinjector

Phase 4

Completed

• Conditions: Anaphylaxis
• Interventions: Device: Epinephrine autoinjector

• Registration Number: NCT01217138
• Lead Sponsor: Gazi University

Brief Summary

Part of the problems related with proper use of epinephrine autoinjector may be related with the design of the autoinjector itself.The aim of the study is to investigate whether minor modifications in the design of currently available epinephrine autoinjector ease its use and abrogate common use errors.

Detailed Description

All interns except the ones who previously worked in allergy department in a medical school were invited to the study. Two identical epinephrine autoinjector trainers (Epipen trainer®) were used, one of which was modified by changing gray safety cap to red and placing a yellow arrow pointing to the black injection tip. Written and visual instruction sheet for each trainer was provided. Participants were asked to demonstrate the use of Epipen trainer either with the original or the modified one. They were scored and timed for demonstration. Primary study parameter was the rate of participants correctly demonstrating the use of epinephrine autoinjector. Secondary study parameters were the mean total score, mean time required to administer autoinjector and unintentional self injection of autoinjector into thumb.

Study Timeline

• Study Start: 2009-06
• Primary Completion: 2010-04
• Study Completion: 2010-05
• Status Verified: 2010-10
• Study First Submitted: 2010-10-07
• Study First Submitted QC: 2010-10-07
• Last Update Submitted: 2010-10-07
• Study First Posted: 2010-10-08
• Last Update Posted: 2010-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 164

Inclusion Criteria

We invited all interns in our faculty to inform about the study and included the ones who gave informed consent -

Exclusion Criteria

Interns who previously worked in allergy department were excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Original epinephrine autoinjector group	Epinephrine autoinjector	Participants were given original epinephrine autoinjector trainer wrapped by a gray sticky paper.
Modified epinephrine autoinjector group	Epinephrine autoinjector	Participants were given the same epinephrine autoinjector trainer wrapped by a gray sticky paper which was modified by changing gray safety cap to red with an atomizer paint and placing a yellow arrow pointing to the black injection tip.

Primary Outcome Measures

Name	Time	Method
Rate of participants correctly demonstrating the use of epinephrine autoinjector.

Secondary Outcome Measures

Name	Time	Method
Mean total score participants get during demonstration of epinephrine autoinjector use
Mean time required to administer epinephrine autoinjector
Unintentional self injection of autoinjector into thumb