Allergy to Neuromuscular Blocking Agents and Pholcodine Exposure (ALPHO)

December 26, 2018 updated by: Central Hospital, Nancy, France

Anaphylaxis to Neuromuscular Blocking Agents and Pholcodine Exposure. Case-control 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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1020

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France
        • Recruiting
        • Chu D' Angers
        • Contact:
          • Martine DROUET, Dr
      • Besançon, France, 25030
      • Bordeaux, France, 33000
      • Caen, France, 14000
      • Clermont- Ferrand, France, 63003
      • Dijon, France, 21033
      • Lille, France, 59037
      • Limoges, France, 87042
      • Marseille, France, 13915
      • Montpellier, France, 34000
        • Recruiting
        • CHU de Montpellier
        • Contact:
          • Pascal Demoly, Pr
      • Nancy, France, 54000
      • Nantes, France
        • Recruiting
        • CHU de Nantes
        • Contact:
          • ANAIS PIPET, Dr
      • Nice, France, 06000
      • Paris, France, 75007
        • Recruiting
        • Fondation Hôpital St Joseph
        • Contact:
          • Marie-Laure MEGRET-GABEAUD, Dr
      • Paris, France, 75877
      • Paris, France
        • Recruiting
        • AP-HP Paris TENON
        • Contact:
          • ANGELE SORIA, Dr
      • Pierre-Bénite, France, 69495
      • Poitiers, France, 86000
      • Reims, France, 51100
      • Rouen, France, 76000
      • Saint- Etienne, France, 42055
        • Recruiting
        • CHU de Saint Etienne
        • Contact:
      • Strasbourg, France, 670000
      • Toulouse, France, 31059
      • Tours, France
        • Recruiting
        • CHU de Tours
        • Contact:
          • Cyrille HOARAU, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: cases with NMBA anaphylaxis
Patients who experienced NMBA anaphylaxis during anesthesia
Other: Blood sampling
Other: intradermal pholcodine allergy test in cases
Other: controls
Patients who underwent anesthesia with NMBA injection but did not experience anaphylaxis
Other: Blood sampling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
within the 12 months before the anesthetic procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 90 days after the general anesthetic procedure, corresponding to the day of inclusion)
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
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
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.
Time Frame: within the 12 months preceding the general anesthetic procedure
IgE measurements: total IgE, IgE specific for pholcodine, quaternary ammoniums (KU/L)
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.
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)
6 to 12 weeks after the general anesthetic procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Collaborators

Sanofi
GlaxoSmithKline
Zambon SpA
Laboratoires URGO
Pierre Fabre Medicament
Biocodex
THE BOOTS COMPANY PLC
LABORATOIRE HEPATOUM
Laboratoires Bouchara-Recordati
ALLIANCE PHARMACEUTICALS LIMITED
BELL SONS & COMPANY
PINEWOOD LABORATORIES LIMITED
THORNTON & ROSS & Ross Ltd
ERNEST JACKSON & Co. Ltd

Investigators

  • Principal Investigator: Pierre GILLET, PU-PH MD, CHU de Nancy
  • Study Director: Paul-Michel MERTES, PU-PH MD, CHU de Strasbourg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2014

Primary Completion (Anticipated)

July 1, 2020

Study Completion (Anticipated)

July 1, 2020

Study Registration Dates

First Submitted

May 12, 2014

First Submitted That Met QC Criteria

September 24, 2014

First Posted (Estimate)

September 26, 2014

Study Record Updates

Last Update Posted (Actual)

December 27, 2018

Last Update Submitted That Met QC Criteria

December 26, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-A01735-38

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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