Make up for the Epinephrine Autoinjector
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| ClinicalTrials.gov Identifier: NCT01217138 |
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Recruitment Status :
Completed
First Posted : October 8, 2010
Last Update Posted : October 8, 2010
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Sponsor:
Gazi University
Information provided by:
Gazi University
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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 |
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 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Anaphylaxis
| Arm | Intervention/treatment |
|---|---|
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Original epinephrine autoinjector group
Participants were given original epinephrine autoinjector trainer wrapped by a gray sticky paper.
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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 |
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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 :
- Rate of participants correctly demonstrating the use of epinephrine autoinjector.
Secondary Outcome Measures :
- 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
Information from the National Library of Medicine
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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.
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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 |
| 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:
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Anaphylaxis, autoinjector, design, epinephrine |
Additional relevant MeSH terms:
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Anaphylaxis Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Epinephrine 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 |