Allergy to Neuromuscular Blocking Agents and Pholcodine Exposure

NCT02250729 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1020

Last updated 2018-12-27

No results posted yet for this study

Summary

The main objective of this study is to compare pholcodine exposure in patients having presented with a perianaesthetic anaphylactic reaction to a NMBA (cases) to pholcodine exposure in matched anaesthetised patients with injection of NMBA, who did not present with an anaphylactic reaction (controls).

The secondary objectives of the study are:

* To compare anti-pholcodine IgE, anti-ammonium IV IgE and total IgE levels between the case and control groups.
* To study the concordance between exposure to pholcodine in cases and controls, by means of a patient self-questionnaire on the one hand and, on the other hand, by a computerized drug history, supplemented where relevant by the drug master file.
* To study the impact of taking 1, 2 or 3 sources in account for pholcodine exposition.
* To study the association between exposure to pholcodine and the presence/levels of pholcodine-specific IgE, reflecting sensitisation to pholcodine.
* To study NMBA and pholcodine cross-sensitisation by testing skin reactions to pholcodine in case patients allergic to (at least) one NMBA.

Conditions

Neuromuscular Blocking Agents Anaphylaxis

Interventions

OTHER: intradermal pholcodine allergy test in cases
OTHER: Blood sampling

Principal Investigators

Pierre GILLET, PU-PH MD · Central Hospital, Nancy, France
Paul-Michel MERTES, PU-PH MD · CHU de Strasbourg

Study Design

Allocation: NON_RANDOMIZED
Purpose: DIAGNOSTIC
Masking: NONE
Model: PARALLEL

Eligibility

Min Age: 2 Years
Sex: ALL
Healthy Volunteers: No

Timeline & Regulatory

Start: 2014-07-31
Primary Completion: 2020-07-31
Completion: 2020-07-31

Countries

France

Study Locations

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Summary

Conditions

Interventions

Sponsors & Collaborators

Principal Investigators

Study Design

Eligibility

Timeline & Regulatory

Countries

Study Locations

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