Last updated on December 2018

Allergy to Neuromuscular Blocking Agents and Pholcodine Exposure


Brief description of study

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.

Clinical Study Identifier: NCT02250729

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