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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms

  • Anaphylaxis
  • Neuromuscular Blocking Agents Anaphylaxis

NCT number NCT02250729
Study type Interventional
Source Central Hospital, Nancy, France
Contact Pierre Gillet, MD PhD
Email pierre.gillet@univ.lorraine.fr
Status Recruiting
Phase N/A
Start date July 2014
Completion date July 2020