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Make up for the Epinephrine Autoinjector

Information source: Gazi University
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Anaphylaxis

Intervention: Epinephrine autoinjector (Device)

Phase: Phase 4

Status: Completed

Sponsored by: Gazi University

Official(s) and/or principal investigator(s):
Arzu Bakirtas, Principal Investigator, Affiliation: Gazi Universitry Faculty of Medicine, Department of Pediatric Allergy and Asthma
Mustafa Arga, Principal Investigator, Affiliation: Gazi Universitry Faculty of Medicine, Department of Pediatric Allergy and Asthma
Ferhat Catal, Principal Investigator, Affiliation: Gazi Universitry Faculty of Medicine, Department of Pediatric Allergy and Asthma
Oksan Derinoz, Principal Investigator, Affiliation: Gazi Universitry Faculty of Medicine, Department of Pediatric Emergency
Sadik M Demirsoy, Study Director, Affiliation: Gazi Universitry Faculty of Medicine, Department of Pediatric Allergy and Asthma
Ipek Turktas, Study Director, Affiliation: Gazi Universitry Faculty of Medicine, Department of Pediatric Allergy and Asthma

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Primary outcome: Rate of participants correctly demonstrating the use of epinephrine autoinjector.

Secondary outcome:

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

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.

Eligibility

Minimum age: 21 Years. Maximum age: 26 Years. Gender(s): Both.

Criteria:

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.

-

Locations and Contacts

Additional Information

Starting date: June 2009
Last updated: October 7, 2010

Page last updated: August 20, 2015

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