DEpth of EPinephrine Delivery With Auto-injectors Devices

Anaphylaxis is a serious allergic reaction that is rapid in onset and may cause death. Although there are several causes of fatal anaphylaxis, food allergy is one of the most common. Epinephrine is recommended as the initial treatment of choice for anaphylaxis. A delay in epinephrine administration may contribute to an increased risk of death. Therefore, the World Allergy Organization recommends that, for the treatment of anaphylaxis, epinephrine solution be administered intramuscularly in the mid-anterolateral thigh.

In France 3 auto-injector pens are available: Anapen®, Epipen® and Jext®. For weight> 30 kg, the devices have a needle size respectively of 7.49 mm, 15.02 mm and 15.36 mm. For the weights between 15 and 30 kg needle size is 7.49 mm to 12.7 mm and Anapen® for Epipen® and Jext®.

Several studies suggest that the needle length needle is sometim

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Key information

Conditions

Anaphylactic Shock Anaphylaxis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chr Metz Thionville

Metz, 57085, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

a weight of over 30 kg at Baseline
with food or an Hymenoptera venom allergy (diagnosed by skin tests or serum-specific IgE testing, requiring prescription epinephrine auto-injector pen according to European recommendations,

Exclusion criteria

having a skin lesion on the lateral aspect of the thigh,
with a known or suspected allergy to the contact gel

Treatment and study plan

skin ultrasound

Other

Primary outcomes

Skin-to-muscle and muscle-to-bone distance assessment, with compression, for intramuscular injection depending on needle length of the auto-injector pen.

Time frame: Day 1

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional Metz-Thionville

Other

Registry information

Official study title

Determinants of Muscle - Skin Distance at the Injection Site in Patients With an Indication for the Use of Epinephrine Auto- Injector Pens

Acronym: DEEP

Important dates

Study start: 2016
Primary completion: 2021
Study completion: 2021
First posted: Sep 1, 2016
Registry last updated: Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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