Allergy to Neuromuscular Blocking Agents and Pholcodine Exposure

Central Hospital, Nancy, France1,020 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

1,020

Conditions

Neuromuscular Blocking Agents Anaphylaxis

Interventions

Eligibility

Sex: ALLMin age: 2 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female, age ≥ 2 years old. * Referred to anaesthesia-allergy consultation within (approximately) 6 to 12 weeks of occurrence of peranaesthetic anaphylactic reaction during anaesthesia with administration of NMBAs (only for case patient). * Having given his/her consent (or the 2 parents consent for minors). * Affiliated with a social security scheme or dependent. * Able to answer a medicinal product intake questionnaire * In a clinical condition compatible with skin tests (no skin disease or psychiatric illness, etc.) (only for case patient) * Having stopped any anti-histamine treatment at least 8 days previously (only for case patient). * With positive skin test for the suspected NMBA (ony for case patient). * Patient anaesthetised in a control recruitment centre (only for control patients) * Having undergone anaesthesia with NMBA injection, without onset of peranaesthetic anaphylactic reaction whatever his medical history (only for control patients) Exclusion Criteria: * Patients who have refused, or are unable to give their consent * Patients who have had negative control skin tests * Anaphylaxis suspected to be related to other drugs given on induction of anaesthesia, eg. antibiotics * Having presented with anaphylactic reaction during a previous anaesthesia without NMBA injection * Pregnant females at inclusion or during 12 months before anaesthesia

Locations (24)

CHU d' ANGERS

Angers, France

RECRUITING

CHU de Besançon

Besançon, France

NOT_YET_RECRUITING

CHU de Bordeaux

Bordeaux, France

RECRUITING

CHU de Caen

Caen, France

RECRUITING

CHU de Clermont-Ferrand

Clermont-Ferrand, France

RECRUITING

CHU de Dijon

Dijon, France

RECRUITING

CHRU de Lille

Lille, France

RECRUITING

CHU de Limoges

Limoges, France

RECRUITING

AP-HM

Marseille, France

NOT_YET_RECRUITING

CHU de MONTPELLIER

Montpellier, France

RECRUITING

...and 14 more locations

Outcomes

Primary Outcomes

Exposure to pholcodine

Exposure is measured by autoquestionnaire, patient's pharmaceutical file and drug history by the pharmacist's

Time frame: within the 12 months before the anesthetic procedure

Secondary Outcomes

Anti-pholcodine IgE, anti-ammonium IV IgE and total IgE levels between the case and control groups.

Cases: 6 to 12 weeks after the general anesthetic procedure (corresponding to the day of inclusion) Controls: during their hospitalisation after the general anesthetic procedure (Maximum 90 days after the general anesthetic procedure, corresponding to the day of inclusion)

Time frame: Between 1 day to 12 weeks after the general anesthetic procedure

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.

Time frame: within the 12 months preceeding the general anesthesia

Impact of non subjective sources in pholcodine exposure assessment

We will study if pholcodine exposure criteria measured by autoquestionnaire is modified by taking into account non subjectives sources which are the patient's pharmaceutical file and his drug history by his pharmacist's

Time frame: within the 12 months preceeding general anesthetic procedure

Association between exposure to pholcodine and the presence/levels of pholcodine-specific IgE, reflecting sensitisation to pholcodine.

IgE measurements: total IgE, IgE specific for pholcodine, quaternary ammoniums (KU/L)

Time frame: within the 12 months preceding the general anesthetic procedure

NMBA and pholcodine cross-sensitisation by testing skin reactions to pholcodine in case patients allergic to one NMBA.

Only for Cases : Intradermal tests with diluted pholcodine. Intradermal tests with diluted NMBAs (as usual)

Time frame: 6 to 12 weeks after the general anesthetic procedure

Allergy to Neuromuscular Blocking Agents and Pholcodine Exposure

Overview

Conditions

Interventions

Eligibility

Locations (24)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts