Clinical Trial: Allergy to Neuromuscular Blocking Agents and Pholcodine Exposure

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Anaphylaxis to Neuromuscular Blocking Agents and Pholcodine Exposure. Case-control Study

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.

Detailed Summary:
Sponsor: Central Hospital, Nancy, France

Current Primary Outcome: Exposure to pholcodine [ Time Frame: within the 12 months before the anesthetic procedure ]

Exposure is measured by autoquestionnaire, patient's pharmaceutical file and drug history by the pharmacist's


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Anti-pholcodine IgE, anti-ammonium IV IgE and total IgE levels between the case and control groups. [ Time Frame: 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 20 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. [ Time Frame: within the 12 months preceeding the general anesthesia ]
  • Impact of non subjective sources in pholcodine exposure assessment [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 6 to 12 weeks after the general anesthetic procedure ]

    Only for Cases :

    Intradermal tests with diluted pholcodine. Intradermal tests with diluted NMBAs (as usual)



Original Secondary Outcome: Same as current

Information By: Central Hospital, Nancy, France

Dates:
Date Received: May 12, 2014
Date Started: July 2014
Date Completion: July 2017
Last Updated: March 7, 2016
Last Verified: March 2016