RecruitingPhase 1NCT03523221

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


Sponsor

Hamad Medical Corporation

Enrollment

210 participants

Start Date

Apr 15, 2018

Study Type

INTERVENTIONAL

Conditions

Summary

Anaphylaxis is an acute serious allergic reaction, with multi-organ system manifestations caused by the release of chemical mediators and it is potentially fatal . Between 5% and 14% of patients may experience a recurrence of anaphylaxis 8-12 hours after the initial presentation, called biphasic (late-phase) . The mainstay of treatment for children experiencing anaphylaxis remains adrenaline and H1-antihistamines. Corticosteroids are not life-saving and do not have an immediate effect on the symptoms of anaphylaxis but may help reduce or prevent a biphasic "late phase" reaction . The aim of this study is to compare the efficacy of oral glucocorticoids in prevention of the second phase or biphasic reaction of anaphylaxis, as compared to placebo in children, presenting to the pediatric emergency department (PEC Al-Sadd) with mild to moderate anaphylaxis (Prospective Study). Patients will be randomized to either one of the two treatment: Treatment 1: Dexamethasone 0.6mg/kg oral. Treatment 2 : Placebo All patients will be urgently treated for anaphylaxis according to guideline protocol. Enrolled patients will be given one of the study medications orally, and he /she will observe in the observation room with cardiac monitor and close monitoring by nurse. The treating physician will discharge patient when he/she looks well, breathing comfortably, has oxygen saturation \>94%, stable blood pressure and no gastrointestinal or neurological manifestation. Discharge patients will be sent home on anti-histamine (cetirizine) for 5days. All patients will be followed up for one week post discharge by a phone call asking about the general condition, relapse of symptoms, or need for readmission.


Eligibility

Min Age: 3 MonthsMax Age: 14 Years

Plain Language Summary

Simplified for easier understanding

This study examines whether giving dexamethasone (a steroid) to children who have had a mild to moderate allergic reaction (anaphylaxis) can prevent a delayed second wave of symptoms — called a biphasic reaction — from occurring hours later. Anaphylaxis is a serious, potentially life-threatening allergic response. Even after a patient appears to recover, a second reaction can occur 1–72 hours later without additional allergen exposure. Doctors currently disagree on whether steroids prevent this, and this study aims to provide clearer evidence. The study is open to children aged 3 months to 14 years presenting to the pediatric emergency department with mild to moderate anaphylaxis. You may be eligible if: - Your child is between 3 months and 14 years old - Your child presented to the pediatric emergency department with mild to moderate anaphylaxis You may NOT be eligible if: - Your child had severe anaphylaxis - Your child has a known immunological disease - Your child is currently on steroid therapy - Your child has moderate-to-severe asthma requiring medication Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDexamethasone Oral

use of one dose of Dexamethasone orally.or placebo in addition to regular treatment of anaphylaxis


Locations(1)

Hamad Medical Corporation

Doha, Qatar

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NCT03523221


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