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| Name | Class |
|---|---|
| Zambon SpA | INDUSTRY |
| Laboratoires URGO | INDUSTRY |
| THE BOOTS COMPANY PLC | UNKNOWN |
| Pierre Fabre Medicament |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cases with NMBA anaphylaxis | Experimental | Patients who experienced NMBA anaphylaxis during anesthesia |
|
| controls | Other | Patients who underwent anesthesia with NMBA injection but did not experience anaphylaxis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intradermal pholcodine allergy test in cases | Other |
| ||
| Blood sampling |
| Measure | Description | Time Frame |
|---|---|---|
| Exposure to pholcodine | Exposure is measured by autoquestionnaire, patient's pharmaceutical file and drug history by the pharmacist's | within the 12 months before the anesthetic procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Between 1 day to 12 weeks after the general anesthetic procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pierre Gillet, MD PhD | Contact | pierre.gillet@univ.lorraine.fr |
| Name | Affiliation | Role |
|---|---|---|
| Pierre GILLET, PU-PH MD | Central Hospital, Nancy, France | Principal Investigator |
| Paul-Michel MERTES, PU-PH MD | CHU de Strasbourg | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU d' ANGERS | Recruiting | Angers | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36967281 | Derived | 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. |
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| 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 |
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| Other |
|
| 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. | 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 | 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) | 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) | 6 to 12 weeks after the general anesthetic procedure |
| CHU de Besançon | Not yet recruiting | Besançon | 25030 | France |
|
| CHU de Bordeaux | Recruiting | Bordeaux | 33000 | France |
|
| CHU de Caen | Recruiting | Caen | 14000 | France |
|
| CHU de Clermont-Ferrand | Recruiting | Clermont-Ferrand | 63003 | France |
|
| CHU de Dijon | Recruiting | Dijon | 21033 | France |
|
| CHRU de Lille | Recruiting | Lille | 59037 | France |
|
| CHU de Limoges | Recruiting | Limoges | 87042 | France |
|
| AP-HM | Not yet recruiting | Marseille | 13915 | France |
|
| CHU de MONTPELLIER | Recruiting | Montpellier | 34000 | France |
|
| CHRU de Nancy | Recruiting | Nancy | 54000 | France |
|
| CHU de NANTES | Recruiting | Nantes | France |
|
| CHU de Nice | Recruiting | Nice | 06000 | France |
|
| Fondation Hôpital St Joseph | Recruiting | Paris | 75007 | France |
|
| AP-HP- Hôpital Bichat | Recruiting | Paris | 75877 | France |
|
| AP-HP Paris TENON | Recruiting | Paris | France |
|
| Hospices Civils de Lyon | Recruiting | Pierre-Bénite | 69495 | France |
|
| CHU de Poitiers | Recruiting | Poitiers | 86000 | France |
|
| CHU de Reims | Recruiting | Reims | 51100 | France |
|
| CHU de Rouen | Recruiting | Rouen | 76000 | France |
|
| CHU de Saint Etienne | Recruiting | Saint-Etienne | 42055 | France |
|
| CHU de Strasbourg | Recruiting | Strasbourg | 670000 | France |
|
| CHU de Toulouse | Recruiting | Toulouse | 31059 | France |
|
| CHU de TOURS | Recruiting | Tours | France |
|
| ID | Term |
|---|---|
| D000707 | Anaphylaxis |
| ID | Term |
|---|---|
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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