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Perioperative Hypersensitivity in Children

Primary Purpose

Drug Allergy

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
diagnostics
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Drug Allergy focused on measuring children,, anesthesia, anaphylaxis

Eligibility Criteria

0 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Istanbul University-Cerrahpasa

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Children with perioperative hypersensitivity

Arm Description

Children with perioperative hypersensitivity

Outcomes

Primary Outcome Measures

Perioperative hypersensitivity frequency

Secondary Outcome Measures

Defining the culprit agent
skin tests, specific immunoglobulin E levels and basophil activation tests were performed

Full Information

First Posted
January 11, 2023
Last Updated
January 20, 2023
Sponsor
Istanbul University - Cerrahpasa (IUC)
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1. Study Identification

Unique Protocol Identification Number
NCT05706246
Brief Title
Perioperative Hypersensitivity in Children
Official Title
Perioperative Hypersensitivity in Children; a Prospective Multidisciplinary Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
June 30, 2020 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
June 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
There are limited studies on perioperative hypersensitivity (POH) reactions in children. The diagnosis of POH might be underestimated due to the difficulty of recognizing the reactions. Anaphylaxis may go unnoticed due to the unconscious state of the patient. Urticaria may be overlooked due to the sterile covers. This study aimed to evaluate POH reactions prospectively.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Allergy
Keywords
children,, anesthesia, anaphylaxis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Children with perioperative hypersensitivity
Arm Type
Other
Arm Description
Children with perioperative hypersensitivity
Intervention Type
Diagnostic Test
Intervention Name(s)
diagnostics
Intervention Description
Serum tryptase levels were evaluated in all suspected children with perioperative hypersensitivity
Primary Outcome Measure Information:
Title
Perioperative hypersensitivity frequency
Time Frame
immediately after the reaction, within two hours following the reaction and basal tryptase levels
Secondary Outcome Measure Information:
Title
Defining the culprit agent
Description
skin tests, specific immunoglobulin E levels and basophil activation tests were performed
Time Frame
4 weeks after the reaction

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayca Kiykim
Organizational Affiliation
Istanbul University - Cerrahpasa (IUC)
Official's Role
Study Director
Facility Information:
Facility Name
Istanbul University-Cerrahpasa
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Perioperative Hypersensitivity in Children

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