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Make up for the Epinephrine Autoinjector

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01217138
Enrollment
164
Registered
2010-10-08
Start date
2009-06-30
Completion date
2010-05-31
Last updated
2010-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anaphylaxis

Keywords

Anaphylaxis, autoinjector, design, epinephrine

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.

Interventions

DEVICEEpinephrine 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.

Sponsors

Gazi University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 26 Years
Healthy volunteers
Yes

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. \-

Design outcomes

Primary

MeasureTime frame
Rate of participants correctly demonstrating the use of epinephrine autoinjector.

Secondary

MeasureTime frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026