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临床试验/NCT07231393
NCT07231393已完成不适用

Evaluation of Observation Periods and Biphasic Reaction Risk Factors in Pediatric Anaphylaxis Cases in the Pediatric Emergency Department: A Retrospective Study

Aydin Adnan Menderes University0 个研究点目标入组 67 人开始时间: 2014年5月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
67
主要终点
Incidence of Biphasic Reactions

研究概览

简要总结

This study reviews the medical records of children who presented to the pediatric emergency department of Adnan Menderes University Hospital with a diagnosis of anaphylaxis between January 2014 and December 2024. The aim is to determine how long children were observed in the emergency department, how often biphasic reactions (a second wave of symptoms) occurred, and which risk factors (such as delayed adrenaline use or asthma) may increase this risk. The results will help improve the care of children with anaphylaxis and guide recommendations for safe observation times.

详细描述

Anaphylaxis is a severe, potentially life-threatening systemic hypersensitivity reaction with rapid onset. Its incidence in children has been rising worldwide. Although international recommendations emphasize the importance of post-reaction monitoring, the optimal observation period in pediatric patients remains uncertain, largely due to the risk of biphasic reactions, defined as recurrence of symptoms after initial resolution within 1-72 hours.

This retrospective observational study was conducted in the Pediatric Emergency Department of Adnan Menderes University Hospital. All patients younger than 18 years who presented with anaphylaxis between January 1, 2014, and December 31, 2024, were included. Diagnosis was based on the World Allergy Organization (WAO) 2020 criteria. Data were obtained from electronic medical records and emergency department charts.

Collected variables included demographics (age, sex), season of presentation, suspected triggers (food, drug, insect sting, exercise, idiopathic), clinical manifestations (cutaneous, respiratory, cardiovascular, gastrointestinal, neurological), comorbidities (such as asthma), acute treatments (epinephrine administration, time to first dose, number of doses, corticosteroids, antihistamines, fluid therapy), observation duration, need for hospital admission, and occurrence of biphasic reactions.

The primary objective is to determine the incidence and timing of biphasic reactions. Secondary objectives are to assess the average observation period in the emergency department, the frequency of hospital admission, and risk factors associated with biphasic reactions, including delayed epinephrine administration and history of asthma. Statistical analysis will include descriptive methods, group comparisons, and logistic regression to identify independent predictors of biphasic reactions.

This study is expected to contribute real-world data on pediatric anaphylaxis and inform clinical practice regarding safe observation times. Results will be compared with existing evidence and may support improvements in pediatric emergency protocols for anaphylaxis management.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
0 Months 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age <18 years
  • Diagnosis of anaphylaxis according to World Allergy Organization (WAO) 2020 criteria
  • Complete clinical data available in medical records

排除标准

  • Incomplete or missing clinical data
  • Cases not meeting WAO 2020 anaphylaxis definition
  • Patients presenting with isolated urticaria or localized allergic reactions only

结局指标

主要结局

Incidence of Biphasic Reactions

时间窗: Within 72 hours of the initial anaphylaxis episode

he proportion of pediatric patients who developed a biphasic reaction, defined as recurrence of anaphylaxis symptoms after complete resolution of the initial episode, within 1-72 hours.

次要结局

  • Mean Observation Period in the Pediatric Emergency Department(During index visit (hours))
  • Risk Factors Associated with Biphasic Reactions(During index visit and follow-up within 72 hours)

研究者

发起方
Aydin Adnan Menderes University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Aykut Çağlar, MD

Assoc. Prof

Aydin Adnan Menderes University

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