Allergy to Neuromuscular Blocking Agents and Pholcodine Exposure
Study Purpose
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.
Recruitment Criteria
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Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
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Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
| Eligible Ages | 2 Years and Over |
| Gender | All |
Trial Details
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Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT02250729 |
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Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
N/A |
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Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Central Hospital, Nancy, France |
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Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Pierre GILLET, PU-PH MDPaul-Michel MERTES, PU-PH MD |
| Principal Investigator Affiliation | CHU de NancyCHU de Strasbourg |
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Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Other, Industry |
| Overall Status | Recruiting |
| Countries | France |
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Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Neuromuscular Blocking Agents Anaphylaxis |
Contact a Trial Team
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