DEpth of EPinephrine Delivery With Auto-injectors Devices (DEEP)

Centre Hospitalier Régional Metz-Thionville

Status: Completed

Conditions: Anaphylactic Shock

Treatments: Other: skin ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT02886468

2016-03-CHRMT

Details and patient eligibility

About

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

Enrollment: 107 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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107 participants in 1 patient group

ultrasound images

Experimental group

Description:

ultrasound images of the anterolateral aspect of the mid-right thigh

Treatment:

Other: skin ultrasound