Clinical trial NCT01217138: Make up for the Epinephrine Autoinjector
Official title: Make up for the Epinephrine Autoinjector: Effect on Its Use by Untrained Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anaphylaxis
Keywords: Anaphylaxis, autoinjector, design, epinephrine
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2010-10-08
Enrollment: 164
Sex: ALL
Minimum age (years): 21
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility 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.

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Primary outcomes:
measure: Rate of participants correctly demonstrating the use of epinephrine autoinjector.
Secondary outcomes:
measure: Mean total score participants get during demonstration of epinephrine autoinjector use
measure: Mean time required to administer epinephrine autoinjector
measure: Unintentional self injection of autoinjector into thumb
Other outcomes:
Locations:
Study officials:
affiliation: Gazi Universitry Faculty of Medicine, Department of Pediatric Allergy and Asthma
name: Arzu Bakirtas
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi Universitry Faculty of Medicine, Department of Pediatric Allergy and Asthma
name: Mustafa Arga
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi Universitry Faculty of Medicine, Department of Pediatric Allergy and Asthma
name: Ferhat Catal
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi Universitry Faculty of Medicine, Department of Pediatric Emergency
name: Oksan Derinoz
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi Universitry Faculty of Medicine, Department of Pediatric Allergy and Asthma
name: Sadik M Demirsoy
role: STUDY_DIRECTOR
affiliation: Gazi Universitry Faculty of Medicine, Department of Pediatric Allergy and Asthma
name: Ipek Turktas
role: STUDY_DIRECTOR
References:
citation: Bakirtas A, Arga M, Catal F, Derinoz O, Demirsoy MS, Turktas I. Make-up of the epinephrine autoinjector: the effect on its use by untrained users. Pediatr Allergy Immunol. 2011 Nov;22(7):729-33. doi: 10.1111/j.1399-3038.2011.01195.x. Epub 2011 Jul 13.