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Make up for the Epinephrine Autoinjector

NCT01217138 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 164

Last updated 2010-10-08

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Gazi University

    lead OTHER

Principal Investigators

  • Arzu Bakirtas · Gazi Universitry Faculty of Medicine, Department of Pediatric Allergy and Asthma

  • Mustafa Arga · Gazi Universitry Faculty of Medicine, Department of Pediatric Allergy and Asthma

  • Ferhat Catal · Gazi Universitry Faculty of Medicine, Department of Pediatric Allergy and Asthma

  • Oksan Derinoz · Gazi Universitry Faculty of Medicine, Department of Pediatric Emergency

  • Sadik M Demirsoy · Gazi Universitry Faculty of Medicine, Department of Pediatric Allergy and Asthma

  • Ipek Turktas · Gazi Universitry Faculty of Medicine, Department of Pediatric Allergy and Asthma

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
26 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2010-04-30
Completion
2010-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01217138 on ClinicalTrials.gov