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Completed

NCT Number: NCT01217138

Make up for the Epinephrine Autoinjector

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.

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Key information

Conditions

Anaphylaxis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases

Age range

21 year–26 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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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Treatment and study plan

Epinephrine autoinjector

Device

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.

Other names: Epipen trainer®, Meridian Medical Technologies, Inc. Columbia, USA

Primary outcomes

  1. Rate of participants correctly demonstrating the use of epinephrine autoinjector.

Secondary outcomes

  1. Mean total score participants get during demonstration of epinephrine autoinjector use

  2. Mean time required to administer epinephrine autoinjector

  3. Unintentional self injection of autoinjector into thumb

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Oct 8, 2010
Registry last updated
Oct 8, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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