Trial Radar
Sign in

NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

Allergy to Neuromuscular Blocking Agents and Pholcodine Exposure
Allergy to Neuromuscular Blocking Agents and Pholcodine Exposure

NCT02250729

UnknownNA

Sponsor: Central Hospital, Nancy, France

Conditions: Neuromuscular Blocking Agents Anaphylaxis

Interventions: intradermal pholcodine allergy test in cases, Blood sampling

Countries: France

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.

Eligibility overview

Sex: ALL

Age: 2 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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
Locations (24)
  • Angers, France
  • Besançon, France
  • Bordeaux, France
  • Caen, France
  • Clermont-Ferrand, France
  • Dijon, France
  • Lille, France
  • Limoges, France
  • Marseille, France
  • Montpellier, France
  • Nancy, France
  • Nantes, France
  • Nice, France
  • Paris, France
  • Paris, France
  • Paris, France
  • Pierre-Bénite, France
  • Poitiers, France
  • Reims, France
  • Rouen, France
  • Saint-Etienne, France
  • Strasbourg, France
  • Toulouse, France
  • Tours, France