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

ConditionAnaphylaxis
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age3-14
SponsorHamad Medical Corporation

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

All patients 3 monthes-14years presenting to the Pediatric Emergency Department (AlSadd) with mild to moderate anaphylaxis

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dexamethasone Oral

    Drug

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

Treatment groups

210 Participants
are divided into 2 treatment groups
Group A: Dexamethasone armActive comparator 1 intervention
Group B: Placebo armPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Use of single dose of oral Dexamethasone decrease revisit to health center facility with relapse of anaphylaxis.

Would the use of single dose of oral Dexamethasone decrease revisit to health center facility with relapse of anaphylaxis signs and symptoms within one week after enrollment?

Time frame
2 years

Secondary outcomes

1

use of oral Dexamethasone decrease the need for second dose of epinephrine after discharge from hospital.

Would the use of oral Dexamethasone decrease the need for second dose of epinephrine after discharge from hospital?

Time frame
2 years

Other outcomes

Sponsors and contacts

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