Make up for the Epinephrine Autoinjector

NCT01217138 | Completed Phase 4

• 1 other identifier: 232-05/25/2009
• Study Type: interventional
• Target: 164
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anaphylaxis

Keywords

Anaphylaxis, autoinjector, design, epinephrine

Outcome Measures

Primary Outcomes (1)

• Rate of participants correctly demonstrating the use of epinephrine autoinjector.

Secondary Outcomes (3)

• 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

Study Arms (2)

Original epinephrine autoinjector group

OTHER

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

Device: Epinephrine autoinjector

Modified epinephrine autoinjector group

ACTIVE COMPARATOR

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

Interventions

Epinephrine autoinjector 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.

Also known as: Epipen trainer®, Meridian Medical Technologies, Inc. Columbia, USA

Modified epinephrine autoinjector group; Original epinephrine autoinjector group

Eligibility Criteria

• Age: 21 Years - 26 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• Gazi University: lead

Related Publications (1)

• Bakirtas A, Arga M, Catal F, Derinoz O, Demirsoy MS, Turktas I. Make-up of the epinephrine autoinjector: the effect on its use by untrained users. Pediatr Allergy Immunol. 2011 Nov;22(7):729-33. doi: 10.1111/j.1399-3038.2011.01195.x. Epub 2011 Jul 13.

  PMID: 21749463 DERIVED

MeSH Terms

Conditions

Anaphylaxis

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 7, 2010
• First Posted: October 8, 2010
• Study Start: June 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: May 1, 2010
• Last Updated: October 8, 2010

Record last verified: 2010-10