Neuromuscular Blocking Agents Anaphylaxis Clinical Trial
— ALPHOOfficial title:
Anaphylaxis to Neuromuscular Blocking Agents and Pholcodine Exposure. Case-control Study
| NCT number | NCT02250729 |
| Other study ID # | 2012-A01735-38 |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | July 2014 |
| Est. completion date | July 2020 |
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.
| Status | Recruiting |
| Enrollment | 1020 |
| Est. completion date | July 2020 |
| Est. primary completion date | July 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 2 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | 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 | AP-HP Paris TENON | Paris | |
| France | AP-HP- Hôpital Bichat | Paris | |
| France | Fondation Hôpital St Joseph | 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Central Hospital, Nancy, France | ALLIANCE PHARMACEUTICALS LIMITED, BELL SONS & COMPANY, Biocodex, ERNEST JACKSON & Co. Ltd, GlaxoSmithKline, LABORATOIRE HEPATOUM, Laboratoires Bouchara-Recordati, Laboratoires URGO, Pierre Fabre Medicament, PINEWOOD LABORATORIES LIMITED, Sanofi, THE BOOTS COMPANY PLC, THORNTON & ROSS & Ross Ltd, Zambon SpA |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | ||
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 |