An interventional study of intradermal pholcodine allergy test in cases and Blood sampling in Neuromuscular Blocking Agents Anaphylaxis, sponsored by Central Hospital, Nancy, France. Status unknown at 24 sites in France. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2018-12-27.
Sponsored by Central Hospital, Nancy, France · Not applicable, Interventional, and Diagnostic
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:
88 studies on the registry are indexed under Anaphylaxis; 16 are open to participants now.
This study's planned enrollment of 1,020 is above the median of 40 across 40 interventional studies indexed under Anaphylaxis.
Browse Anaphylaxis studies →Central Hospital, Nancy, France is the lead sponsor of 778 studies on the registry; 183 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients who experienced NMBA anaphylaxis during anesthesia
Other: intradermal pholcodine allergy test in cases · Other: Blood sampling
Patients who underwent anesthesia with NMBA injection but did not experience anaphylaxis
Other: Blood sampling
Exposure to pholcodine
Exposure is measured by autoquestionnaire, patient's pharmaceutical file and drug history by the pharmacist's
Time frame: within the 12 months before the anesthetic procedure
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)
Time frame: Between 1 day to 12 weeks after the general anesthetic procedure
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.
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 6 to 12 weeks after the general anesthetic procedure
This study is status unknown, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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Central Hospital, Nancy, France