Use of Dexamethasone in Prevention of the Second Phase or a Biphasic Reaction of Anaphylaxis in Children Aged 3 Months to 14 Years

What this Trial Is About

Anaphylaxis is a serious and potentially life-threatening allergic reaction affecting multiple organ systems, caused by the release of chemical mediators. This trial evaluates whether giving oral glucocorticoids, specifically dexamethasone, can help prevent a second phase or biphasic reaction that sometimes occurs 8-12 hours after the initial anaphylaxis in children aged 3 months to 14 years. The study aims to provide prospective evidence on the use of steroids in treating anaphylaxis, as current data mainly come from retrospective studies and reports. Children presenting with mild to moderate anaphylaxis to the pediatric emergency department will be randomly assigned to receive either a single oral dose of dexamethasone or a placebo, in addition to standard urgent treatment including adrenaline and antihistamines. After receiving the study medication, participants will be monitored closely in an observation room with cardiac monitoring and nursing care until they are stable enough for discharge. Upon discharge, all children will receive antihistamine treatment for five days and will be followed up by phone for one week to check on their condition and any recurrence of symptoms. Throughout the study, researchers will closely monitor patients’ vital signs and symptoms during the observation period and follow up after discharge to assess relapse of anaphylaxis or the need for additional treatments such as epinephrine. The primary outcome being measured is whether dexamethasone reduces the need for patients to revisit a health facility due to relapse within two years. Safety, symptom control, and the prevention of biphasic reactions will be carefully evaluated during and after the study period.

Use of Dexamethasone in Prevention of the Second Phase or a Biphasic Reaction of Anaphylaxis