Clinical trial NCT02250729: Allergy to Neuromuscular Blocking Agents and Pholcodine Exposure
Official title: Anaphylaxis to Neuromuscular Blocking Agents and Pholcodine Exposure. Case-control Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neuromuscular Blocking Agents Anaphylaxis
Keywords: anaphylaxis
pholcodine
neuromuscular blocking agents
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
Collaborators: name: Zambon SpA
name: Laboratoires URGO
name: THE BOOTS COMPANY PLC
name: Pierre Fabre Medicament
name: LABORATOIRE HEPATOUM
name: Biocodex
name: Sanofi
name: RECORDATI GROUP
name: GlaxoSmithKline
name: ALLIANCE PHARMACEUTICALS LIMITED
name: BELL SONS & COMPANY
name: PINEWOOD LABORATORIES LIMITED
name: THORNTON & ROSS & Ross Ltd
name: ERNEST JACKSON & Co. Ltd
First posted: 2014-09-26
Enrollment: 1020
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Exposure to pholcodine
timeFrame: within the 12 months before the anesthetic procedure
Secondary outcomes:
measure: Anti-pholcodine IgE, anti-ammonium IV IgE and total IgE levels between the case and control groups.
timeFrame: Between 1 day to 12 weeks after the general anesthetic procedure
measure: 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.
timeFrame: within the 12 months preceeding the general anesthesia
measure: Impact of non subjective sources in pholcodine exposure assessment
timeFrame: within the 12 months preceeding general anesthetic procedure
measure: Association between exposure to pholcodine and the presence/levels of pholcodine-specific IgE, reflecting sensitisation to pholcodine.
timeFrame: within the 12 months preceding the general anesthetic procedure
measure: NMBA and pholcodine cross-sensitisation by testing skin reactions to pholcodine in case patients allergic to one NMBA.
timeFrame: 6 to 12 weeks after the general anesthetic procedure
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU d' ANGERS
city: Besançon
country: France
facility: CHU de Besançon
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Caen
country: France
facility: CHU de Caen
city: Clermont- Ferrand
country: France
facility: CHU de Clermont-Ferrand
city: Dijon
country: France
facility: CHU de Dijon
city: Lille
country: France
facility: CHRU de Lille
city: Limoges
country: France
facility: CHU de Limoges
city: Marseille
country: France
facility: AP-HM
city: Montpellier
country: France
facility: CHU de MONTPELLIER
city: Nancy
country: France
facility: CHRU de Nancy
city: Nantes
country: France
facility: CHU de NANTES
city: Nice
country: France
facility: CHU de Nice
city: Paris
country: France
facility: Fondation Hôpital St Joseph
city: Paris
country: France
facility: AP-HP- Hôpital Bichat
city: Paris
country: France
facility: AP-HP Paris TENON
city: Pierre-Bénite
country: France
facility: Hospices Civils de Lyon
city: Poitiers
country: France
facility: CHU de Poitiers
city: Reims
country: France
facility: CHU de Reims
city: Rouen
country: France
facility: CHU de Rouen
city: Saint- Etienne
country: France
facility: CHU de Saint Etienne
city: Strasbourg
country: France
facility: CHU de Strasbourg
city: Toulouse
country: France
facility: CHU de Toulouse
city: Tours
country: France
facility: CHU de TOURS
Study officials:
affiliation: Central Hospital, Nancy, France
name: Pierre GILLET, PU-PH MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU de Strasbourg
name: Paul-Michel MERTES, PU-PH MD
role: STUDY_DIRECTOR
References: