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

NCT03523221 | Recruiting Phase 1 DMC

• 1 other identifier: 171661/17
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anaphylaxis

Keywords

Mild -Moderate Anaphylaxis

Outcome Measures

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?

  2 years

Secondary Outcomes (1)

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

  2 years

Study Arms (2)

Dexamethasone arm

ACTIVE COMPARATOR

All patients will be Urgently treated for anaphylaxis according to guideline protocol. Enrolled patients will be given one of study medication orally, and he /she will observe in the observation room with cardiac monitor and close monitoring by nurse.

Drug: Dexamethasone Oral

Placebo arm

PLACEBO COMPARATOR

All patients will be Urgently treated for anaphylaxis according to guideline protocol. Enrolled patients will be given one of study medication orally, and he /she will observe in the observation room with cardiac monitor and close monitoring by nurse.

Drug: Dexamethasone Oral

Interventions

Dexamethasone Oral DRUG

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

Dexamethasone arm; Placebo arm

Eligibility Criteria

• Age: 3 Months - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Patients with severe anaphylaxis. Patient with history of immunological diseases. Patients on steroids therapy Patient with moderate-severe asthma on medication Patients with severe asthma

Sponsors & Collaborators

• Hamad Medical Corporation: lead

Study Sites (1)

Hamad Medical Corporation

Doha, 3050, Qatar

RECRUITING

Related Publications (2)

• Al Sayyed R, Alansari K. Randomized blinded pilot trial of corticosteroid after mild-moderate anaphylaxis to prevent recurrence. Medicine (Baltimore). 2025 Aug 1;104(31):e43600. doi: 10.1097/MD.0000000000043600.

  PMID: 40760578 DERIVED

• Burroughs-Ray DC, Wells DR, Dennis MM, Jackson CD. Clinical Guideline Highlights for the Hospitalist: Anaphylaxis Management in Adults and Children. J Hosp Med. 2021 Feb;16(2):98-99. doi: 10.12788/jhm.3553.

  PMID: 33496659 DERIVED

MeSH Terms

Conditions

Anaphylaxis

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Khalid Al ansari, FRCP

  Hamad Medical Corporation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rafah Sayyed, Md

CONTACT

+974-55747045; ralsayyed@hamad.qa

Khalid Al Ansari, FRCP

CONTACT

+97444396006; kalansari1@hmc.org.qa

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Pediatrics Emergency Centeres

Study Record Dates

• First Submitted: May 1, 2018
• First Posted: May 14, 2018
• Study Start: April 15, 2018
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: August 14, 2024

Record last verified: 2024-08

Locations

QA (1)