NCT05706246

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 30, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 31, 2023

Completed
Last Updated

January 31, 2023

Status Verified

January 1, 2023

Enrollment Period

1 year

First QC Date

January 11, 2023

Last Update Submit

January 20, 2023

Conditions

Drug Allergy

Keywords

children,anesthesiaanaphylaxis

Outcome Measures

Primary Outcomes (1)

  • Perioperative hypersensitivity frequency

    immediately after the reaction, within two hours following the reaction and basal tryptase levels

Secondary Outcomes (1)

  • Defining the culprit agent

    4 weeks after the reaction

Study Arms (1)

Children with perioperative hypersensitivity

OTHER

Children with perioperative hypersensitivity

Diagnostic Test: diagnostics

Interventions

diagnosticsDIAGNOSTIC_TEST

Serum tryptase levels were evaluated in all suspected children with perioperative hypersensitivity

Children with perioperative hypersensitivity

Eligibility Criteria

Age0 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • Refusing skin tests

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Drug HypersensitivityAnaphylaxis

Interventions

Rapid Diagnostic Tests

Condition Hierarchy (Ancestors)

Drug-Related Side Effects and Adverse ReactionsChemically-Induced DisordersHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesPoint-of-Care TestingPoint-of-Care SystemsPatient Care ManagementHealth Services Administration

Study Officials

  • Ayca Kiykim

    Istanbul University - Cerrahpasa

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 11, 2023

First Posted

January 31, 2023

Study Start

June 30, 2020

Primary Completion

June 30, 2021

Study Completion

June 28, 2022

Last Updated

January 31, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)