Make up for the Epinephrine Autoinjector

October 7, 2010 updated by: Gazi University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

164

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 26 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Original epinephrine autoinjector group
Participants were given original epinephrine autoinjector trainer wrapped by a gray sticky paper.
Device: 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.
Other Names:
  • Epipen trainer®, Meridian Medical Technologies, Inc. Columbia, USA
Active Comparator: 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.
Device: 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.
Other Names:
  • Epipen trainer®, Meridian Medical Technologies, Inc. Columbia, USA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Rate of participants correctly demonstrating the use of epinephrine autoinjector.

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gazi University

Investigators

  • Principal Investigator: Arzu Bakirtas, Gazi Universitry Faculty of Medicine, Department of Pediatric Allergy and Asthma
  • Principal Investigator: Mustafa Arga, Gazi Universitry Faculty of Medicine, Department of Pediatric Allergy and Asthma
  • Principal Investigator: Ferhat Catal, Gazi Universitry Faculty of Medicine, Department of Pediatric Allergy and Asthma
  • Principal Investigator: Oksan Derinoz, Gazi Universitry Faculty of Medicine, Department of Pediatric Emergency
  • Study Director: Sadik M Demirsoy, Gazi Universitry Faculty of Medicine, Department of Pediatric Allergy and Asthma
  • Study Director: Ipek Turktas, Gazi Universitry Faculty of Medicine, Department of Pediatric Allergy and Asthma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

October 7, 2010

First Submitted That Met QC Criteria

October 7, 2010

First Posted (Estimate)

October 8, 2010

Study Record Updates

Last Update Posted (Estimate)

October 8, 2010

Last Update Submitted That Met QC Criteria

October 7, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 232-05/25/2009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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