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Make up for the Epinephrine Autoinjector

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ClinicalTrials.gov Identifier: NCT01217138
Recruitment Status : Completed
First Posted : October 8, 2010
Last Update Posted : October 8, 2010
Sponsor:
Information provided by:
Gazi University

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.

Condition or disease Intervention/treatment Phase
Anaphylaxis Device: Epinephrine autoinjector Phase 4

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  (Clinical Trial)
Actual Enrollment : 164 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Make up for the Epinephrine Autoinjector: Effect on Its Use by Untrained Users
Study Start Date : June 2009
Actual Primary Completion Date : April 2010
Actual Study Completion Date : May 2010


Arm Intervention/treatment
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 Name: 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 Name: Epipen trainer®, Meridian Medical Technologies, Inc. Columbia, USA




Primary Outcome Measures :
  1. Rate of participants correctly demonstrating the use of epinephrine autoinjector.

Secondary Outcome Measures :
  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


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Ages Eligible for Study:   21 Years to 26 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01217138


Sponsors and Collaborators
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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gazi University Faculty of Medicine
ClinicalTrials.gov Identifier: NCT01217138     History of Changes
Other Study ID Numbers: 232-05/25/2009
First Posted: October 8, 2010    Key Record Dates
Last Update Posted: October 8, 2010
Last Verified: October 2010

Keywords provided by Gazi University:
Anaphylaxis, autoinjector, design, epinephrine

Additional relevant MeSH terms:
Epinephrine
Racepinephrine
Epinephryl borate
Anaphylaxis
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents