Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05706246
Other study ID # HIPOP
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 30, 2020
Est. completion date June 28, 2022

Study information

Verified date January 2023
Source Istanbul University - Cerrahpasa (IUC)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 29
Est. completion date June 28, 2022
Est. primary completion date June 30, 2021
Accepts healthy volunteers No
Gender All
Age group 0 Years to 18 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
diagnostics
Serum tryptase levels were evaluated in all suspected children with perioperative hypersensitivity

Locations

Country Name City State
Turkey Istanbul University-Cerrahpasa Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul University - Cerrahpasa (IUC)

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Perioperative hypersensitivity frequency immediately after the reaction, within two hours following the reaction and basal tryptase levels
Secondary Defining the culprit agent skin tests, specific immunoglobulin E levels and basophil activation tests were performed 4 weeks after the reaction
See also
  Status Clinical Trial Phase
Enrolling by invitation NCT06414694 - Inpatient Penicillin Delabeling for Low-Risk Patients Phase 4
Recruiting NCT04920721 - Retrospective Study of Immediate Hypersensitivity (IHS) Reactions to Platinum Salts in the University Hospital of Nancy
Completed NCT02118987 - Study of Omalizumab as Adjuvant Therapy in Chemotherapy Desensitization Phase 1
Enrolling by invitation NCT03164044 - Improved Basophil Activation Test (BAT) in the Diagnostics of Drug Allergy
Completed NCT02094638 - Post-Marketing Surveillance of the Tanreqing Injection: a Real World Study N/A
Not yet recruiting NCT06399601 - A Training Program of Drug Allergy for Healthcare Professionals N/A
Completed NCT03784482 - Multiple Drug Hypersensitivity Syndrome
Not yet recruiting NCT06406114 - Optimizing the Diagnostic Approach to Cephalosporin Allergy Testing Phase 2
Recruiting NCT05820802 - High Dimensional Analysis of Immune Cells in Pediatric Patients