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Clinical Trials/NCT01217138
NCT01217138CompletedPhase 4

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

Gazi University0 sites164 target enrollmentStarted: June 2009Last updated:
Conditions

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
164
Primary Endpoint
Rate of participants correctly demonstrating the use of epinephrine autoinjector.

Study Overview

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.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Masking
None

Eligibility Criteria

Ages
21 Years to 26 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Outcomes

Primary Outcomes

Rate of participants correctly demonstrating the use of epinephrine autoinjector.

Secondary Outcomes

  • 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

Investigators

Sponsor Class
Other

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