Status:
UNKNOWN
Allergy to Neuromuscular Blocking Agents and Pholcodine Exposure
Lead Sponsor:
Central Hospital, Nancy, France
Collaborating Sponsors:
Zambon SpA
Laboratoires URGO
Conditions:
Neuromuscular Blocking Agents Anaphylaxis
Eligibility:
All Genders
2+ years
Phase:
NA
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 anaesth...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2020
Estimated Enrollment :
1020 Patients enrolled
Trial Details
Trial ID
NCT02250729
Start Date
July 1 2014
End Date
July 1 2020
Last Update
December 27 2018
Active Locations (24)
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1
CHU d' ANGERS
Angers, France
2
CHU de Besançon
Besançon, France, 25030
3
CHU de Bordeaux
Bordeaux, France, 33000
4
CHU de Caen
Caen, France, 14000