Actively Recruiting

Phase 1
Age: 3Months - 14Years
All Genders
Healthy Volunteers
NCT03523221

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

Led by Hamad Medical Corporation · Updated on 2024-08-14

210

Participants Needed

1

Research Sites

346 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 3Months - 14Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 3 months to 14 years with mild to moderate anaphylaxis presenting to the Pediatric Emergency Department (AlSadd)
Not Eligible

You will not qualify if you...

  • Patients with severe anaphylaxis
  • Patients with a history of immunological diseases
  • Patients currently on steroid therapy
  • Patients with moderate to severe asthma who are on medication
  • Patients with severe asthma

AI-Screening

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Trial Site Locations

Total: 1 location

1

Hamad Medical Corporation

Doha, Qatar, 3050

Actively Recruiting

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Research Team

R

Rafah Sayyed, Md

CONTACT

K

Khalid Al Ansari, FRCP

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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