Make up for the Epinephrine Autoinjector

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

164 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2010-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anaphylaxis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Original epinephrine autoinjector group

Participants were given original epinephrine autoinjector trainer wrapped by a gray sticky paper.

Group Type OTHER

Epinephrine autoinjector

Intervention Type 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.

Modified epinephrine autoinjector group

Participants were given the same epinephrine autoinjector trainer wrapped by a gray sticky paper which was modified by changing gray safety cap to red with an atomizer paint and placing a yellow arrow pointing to the black injection tip.

Group Type ACTIVE_COMPARATOR

Epinephrine autoinjector

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Epipen trainer®, Meridian Medical Technologies, Inc. Columbia, USA

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Exclusion Criteria

\-

Minimum Eligible Age

21 Years

Maximum Eligible Age

26 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Gazi University Faculty of Medicine