An observational study in Child, Anaphylaxis and Pediatric Emergency Care, sponsored by Aydin Adnan Menderes University. Completed. Open to participants aged 0 Months to 17 Years. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Aydin Adnan Menderes University · Observational
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.
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.
100 studies on the registry are indexed under Anaphylaxis; 20 are open to participants now.
This study's enrollment of 67 is below the median of 137 across 48 observational studies indexed under Anaphylaxis.
Browse Anaphylaxis studies →Aydin Adnan Menderes University is the lead sponsor of 241 studies on the registry; 51 are open to participants now.
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Children and adolescents (\<18 years) who presented to the Pediatric Emergency Department of Adnan Menderes University Hospital between January 1, 2014, and December 31, 2024, with a diagnosis of anaphylaxis.
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Age \<18 years
Exclusion Criteria:
Children under 18 years of age who presented to the Pediatric Emergency Department of Adnan Menderes University Hospital between January 2014 and December 2024 with a diagnosis of anaphylaxis, defined according to WAO 2020 criteria. All patients meeting eligibility criteria were included retrospectively from medical records.
Incidence of Biphasic Reactions
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.
Time frame: Within 72 hours of the initial anaphylaxis episode
Mean Observation Period in the Pediatric Emergency Department
Average length of observation (in hours) in the pediatric emergency department following initial anaphylaxis management.
Time frame: During index visit (hours)
Risk Factors Associated with Biphasic Reactions
Identification of independent predictors for biphasic reactions (e.g., history of asthma, delayed epinephrine administration, initial clinical severity, need for multiple epinephrine doses).
Time frame: During index visit and follow-up within 72 hours
No study locations are listed for this record.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — We do not plan to share individual participant data. Summary results will be available in published articles.
Ran from May 2014 to primary completion in Nov 2024, 126 months.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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