Neuromuscular Blocking Agents Anaphylaxis
Conditions
Keywords
anaphylaxis, pholcodine, neuromuscular blocking agents
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.
Interventions
OTHERintradermal pholcodine allergy test in cases
OTHERBlood sampling
Sponsors
Zambon SpA
Laboratoires URGO
THE BOOTS COMPANY PLC
Pierre Fabre Medicament
LABORATOIRE HEPATOUM
Biocodex
Sanofi
RECORDATI GROUP
GlaxoSmithKline
ALLIANCE PHARMACEUTICALS LIMITED
BELL SONS & COMPANY
PINEWOOD LABORATORIES LIMITED
THORNTON & ROSS & Ross Ltd
ERNEST JACKSON & Co. Ltd
Central Hospital, Nancy, France
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Exposure to pholcodine | within the 12 months before the anesthetic procedure | Exposure is measured by autoquestionnaire, patient's pharmaceutical file and drug history by the pharmacist's |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anti-pholcodine IgE, anti-ammonium IV IgE and total IgE levels between the case and control groups. | Between 1 day to 12 weeks after the general anesthetic procedure | 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) |
| 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 | within the 12 months preceeding general anesthetic procedure | 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 |
| Association between exposure to pholcodine and the presence/levels of pholcodine-specific IgE, reflecting sensitisation to pholcodine. | within the 12 months preceding the general anesthetic procedure | IgE measurements: total IgE, IgE specific for pholcodine, quaternary ammoniums (KU/L) |
| NMBA and pholcodine cross-sensitisation by testing skin reactions to pholcodine in case patients allergic to one NMBA. | 6 to 12 weeks after the general anesthetic procedure | Only for Cases : Intradermal tests with diluted pholcodine. Intradermal tests with diluted NMBAs (as usual) |
Countries
France
Contacts
Primary ContactPierre Gillet, MD PhD
Outcome results
None listed