Allergy to Neuromuscular Blocking Agents and Pholcodine Exposure
NCT ID: NCT02250729
Last Updated: 2018-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
1020 participants
INTERVENTIONAL
2014-07-31
2020-07-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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cases with NMBA anaphylaxis
Patients who experienced NMBA anaphylaxis during anesthesia
intradermal pholcodine allergy test in cases
Blood sampling
controls
Patients who underwent anesthesia with NMBA injection but did not experience anaphylaxis
Blood sampling
Interventions
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intradermal pholcodine allergy test in cases
Blood sampling
Eligibility Criteria
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Inclusion Criteria
* 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 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
2 Years
ALL
No
Sponsors
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Zambon SpA
INDUSTRY
Laboratoires URGO
INDUSTRY
THE BOOTS COMPANY PLC
UNKNOWN
Pierre Fabre Medicament
INDUSTRY
LABORATOIRE HEPATOUM
UNKNOWN
Biocodex
INDUSTRY
Sanofi
INDUSTRY
RECORDATI GROUP
INDUSTRY
GlaxoSmithKline
INDUSTRY
ALLIANCE PHARMACEUTICALS LIMITED
UNKNOWN
BELL SONS & COMPANY
UNKNOWN
PINEWOOD LABORATORIES LIMITED
UNKNOWN
THORNTON & ROSS & Ross Ltd
UNKNOWN
ERNEST JACKSON & Co. Ltd
UNKNOWN
Central Hospital, Nancy, France
OTHER
Responsible Party
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Principal Investigators
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Pierre GILLET, PU-PH MD
Role: PRINCIPAL_INVESTIGATOR
Central Hospital, Nancy, France
Paul-Michel MERTES, PU-PH MD
Role: STUDY_DIRECTOR
CHU de Strasbourg
Locations
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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
CHRU de Nancy
Nancy, , France
CHU de NANTES
Nantes, , France
CHU de Nice
Nice, , France
Fondation Hôpital St Joseph
Paris, , France
AP-HP- Hôpital Bichat
Paris, , France
AP-HP Paris TENON
Paris, , France
Hospices Civils de Lyon
Pierre-Bénite, , France
CHU de Poitiers
Poitiers, , France
CHU de Reims
Reims, , France
CHU de Rouen
Rouen, , France
CHU de Saint Etienne
Saint-Etienne, , France
CHU de Strasbourg
Strasbourg, , France
CHU de Toulouse
Toulouse, , France
CHU de TOURS
Tours, , France
Countries
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Central Contacts
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Facility Contacts
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Martine DROUET, Dr
Role: primary
Pascal GIRARDIN, MD
Role: primary
Maryline Bordes
Role: primary
Delphine MARIOTTEFAUSSART, MD
Role: primary
Omar OUTTAS, MD
Role: primary
Sandrine SELTZER, MD
Role: primary
FACON Alain, MD
Role: primary
Isabelle ORSEL, MD
Role: primary
Marion GOUITAA-DETTORI, MD
Role: primary
Pascal DEMOLY, Pr
Role: primary
Gérard AUDIBERT, MD-PHD
Role: primary
ANAIS PIPET, Dr
Role: primary
Sylvie LEROY, MD
Role: primary
Marie-Laure MEGRET-GABEAUD, Dr
Role: primary
Dan LONGROIS, MD- PHD
Role: primary
ANGELE SORIA, Dr
Role: primary
Vincent PIRIOU, MD
Role: primary
Marion VERDAGUER, MD
Role: primary
Jean-Marc MALINVOSKY, MD-PHD
Role: primary
Yannick MEUNIER, MD
Role: primary
Charles DZVIGA, MD
Role: primary
Fréderic DE BLAY, MD- PHD
Role: primary
Paul-Michel Mertes, MD- PHD
Role: backup
Alain DIDIER, MD-PHD
Role: primary
Cyrille HOARAU, Dr
Role: primary
References
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Mertes PM, Petitpain N, Tacquard C, Delpuech M, Baumann C, Malinovsky JM, Longrois D, Gouel-Cheron A, Le Quang D, Demoly P, Gueant JL, Gillet P; ALPHO Study Group. Pholcodine exposure increases the risk of perioperative anaphylaxis to neuromuscular blocking agents: the ALPHO case-control study. Br J Anaesth. 2023 Jul;131(1):150-158. doi: 10.1016/j.bja.2023.02.026. Epub 2023 Mar 24.
Other Identifiers
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2012-A01735-38
Identifier Type: -
Identifier Source: org_study_id