Make up for the Epinephrine Autoinjector

Anaphylaxis Clinical Trial

Official title:

Make up for the Epinephrine Autoinjector: Effect on Its Use by Untrained Users

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01217138
• Other study ID #: 232-05/25/2009
• Status: Completed
• Phase: Phase 4
• First received: October 7, 2010
• Last updated: October 7, 2010
• Start date: June 2009
• Est. completion date: May 2010

Study information

• Verified date: October 2010
• Source: Gazi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: May 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 26 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anaphylaxis

Intervention

Device:
• Epinephrine autoinjector
We used 2 epinephrine autoinjector trainers and wrapped them by a gray sticky paper. Then,modified one of the trainers by changing gray safety cap to red with an atomizer paint and placing a yellow arrow pointing to the black injection tip.We provided three-step written and visual instruction sheet to use epinephrine autoinjector in Turkish same as given on the original trainer and changed that of the second trainer according to the modifications we made. Scoring system originally devised by Sicherer et al was used. Participants successively doing all steps were accepted to demonstrate autoinjector use correctly. Participants who tackled with black tip of autoinjector in order to eject needle after removing safety cap was regarded as unsuccessful since this may cause unintentional injection of epinephrine. All participants were scored and timed separately.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gazi University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of participants correctly demonstrating the use of epinephrine autoinjector.
Secondary	Mean total score participants get during demonstration of epinephrine autoinjector use
Secondary	Mean time required to administer epinephrine autoinjector
Secondary	Unintentional self injection of autoinjector into thumb