- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05706246
Perioperative Hypersensitivity in Children
Perioperative Hypersensitivity in Children; a Prospective Multidisciplinary Study
Study Overview
Detailed Description
Patients with intraoperative signs of diffuse erythema, urticaria, angioedema, sudden hypotension, tachycardia, bradycardia, arrhythmia, bronchospasm, vomiting, difficulty in ventilation, and end-tidal carbon dioxide (CO2) increase were included in the study. Reactions were graded from I to IV depending on increasing severity (Grade I, presence of cutaneous signs; Grade II, presence of measurable but non-life-threatening symptoms, including cutaneous effects, arterial hypotension, cough, or difficulty in mechanical ventilation; Grade III, presence of life-threatening reactions: cardiovascular arrest, tachycardia or bradycardia, arrhythmias, severe bronchospasm; Grade IV, circulatory inefficacy, cardiac and/or respiratory arrest).
In case of suspicious findings in terms of hypersensitivity reactions during surgery or recovery from anesthesia; the basal serum tryptase level was recorded at the time of the reaction, 2 hours after the reaction, and any time after 24 hours.
The severity of the reaction, vital signs, treatments applied, and medications administered after the reaction were recorded in the pre-prepared follow-up form. Then, skin tests were performed with all exposure agents,latex and chlorhexidine 4-6 weeks after the reaction in accordance with the records kept by the Pediatric Allergy and Immunology Clinic. A wheal diameter of at least 3mm larger than negative control is regarded a positive skin prick test, while in intradermal testing (IDT), a diameter 3 mm larger than the intracutaneously administered depot of the drug solution following 15-20 min is considered positive. Histamine was used as a positive control, and saline as a negative control. For positive skin test cases, basophil activation test was performed with the available drug. Skin prick and intradermal test concentrations were applied according to the recommendations for non-irritant test concentrations published by the European Network for Drug Allergy (ENDA) (8). Specific immunoglobulin E (spIgE) measurements were performed for latex and chlorhexidine on skin test positive cases, and for penicillin before the skin test for one case that experienced anaphylaxis due to antibiotics. The methodology used was ImmunoCAP® (Thermo Fisher Scientific, Uppsala, Sweden). Serum total tryptase levels were measured with ImmunoCAP® (Thermo Fisher Scientific). The increased serum tryptase value was calculated with the following formula: >1.2*basal tryptase level +2 mcg/L. In suspicious cases where the latex skin test was not clinically compatible, cutaneous provocation with latex was performed. Comparisons were made with the basophil activation test for positive results in drug skin tests.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Istanbul, Turkey
- Istanbul University-Cerrahpasa
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with intraoperative signs of diffuse erythema, urticaria, angioedema, sudden hypotension, tachycardia, bradycardia, arrhythmia, bronchospasm, vomiting, difficulty in ventilation, and end-tidal carbon dioxide (CO2) increase were included in the study.
- Children (0-18 years)
Exclusion Criteria:
- Refusing skin tests
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: Children with perioperative hypersensitivity
|
Serum tryptase levels were evaluated in all suspected children with perioperative hypersensitivity
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Perioperative hypersensitivity frequency
Time Frame: immediately after the reaction, within two hours following the reaction and basal tryptase levels
|
immediately after the reaction, within two hours following the reaction and basal tryptase levels
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Defining the culprit agent
Time Frame: 4 weeks after the reaction
|
skin tests, specific immunoglobulin E levels and basophil activation tests were performed
|
4 weeks after the reaction
|
Collaborators and Investigators
Investigators
- Study Director: Ayca Kiykim, Istanbul University - Cerrahpasa (IUC)
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HIPOP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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