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Anaphylaxis to Neuromuscular Blocking Agents and Pholcodine Exposure. Case-control Study
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.
Age
2 - No limit years
Sex
ALL
Healthy Volunteers
No
CHU d' ANGERS
Angers, France
CHU de Besançon
Besançon, France
CHU de Bordeaux
Bordeaux, France
CHU de Caen
Caen, France
CHU de Clermont-Ferrand
Clermont-Ferrand, France
CHU de Dijon
Dijon, France
CHRU de Lille
Lille, France
CHU de Limoges
Limoges, France
AP-HM
Marseille, France
CHU de MONTPELLIER
Montpellier, France
Start Date
July 1, 2014
Primary Completion Date
July 1, 2020
Completion Date
July 1, 2020
Last Updated
December 27, 2018
1,020
ESTIMATED participants
intradermal pholcodine allergy test in cases
OTHER
Blood sampling
OTHER
Lead Sponsor
Central Hospital, Nancy, France
Collaborators
Data Source & Attribution
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