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

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ClinicalTrials.gov Identifier: NCT03523221
Recruitment Status : Recruiting
First Posted : May 14, 2018
Last Update Posted : August 31, 2021
Sponsor:
Information provided by (Responsible Party):
DR. KHALID AL-ANSARI, Hamad Medical Corporation

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.


Condition or disease Intervention/treatment Phase
Anaphylaxis Drug: Dexamethasone Oral Phase 1

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Use of Dexamethasone in Prevention of the Second Phase or a Biphasic Reaction of Anaphylaxis
Actual Study Start Date : April 15, 2018
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anaphylaxis

Arm Intervention/treatment
Active Comparator: Dexamethasone arm
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
use of one dose of Dexamethasone orally.or placebo in addition to regular treatment of anaphylaxis

Placebo Comparator: Placebo arm
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
use of one dose of Dexamethasone orally.or placebo in addition to regular treatment of anaphylaxis




Primary Outcome Measures :
  1. Use of single dose of oral Dexamethasone decrease revisit to health center facility with relapse of anaphylaxis. [ Time Frame: 2 years ]
    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?


Secondary Outcome Measures :
  1. use of oral Dexamethasone decrease the need for second dose of epinephrine after discharge from hospital. [ Time Frame: 2 years ]
    Would the use of oral Dexamethasone decrease the need for second dose of epinephrine after discharge from hospital?



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Ages Eligible for Study:   3 Months to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03523221


Contacts
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Contact: Rafah Sayyed, Md +974-55747045 ralsayyed@hamad.qa
Contact: Khalid Al Ansari, FRCP +97444396006 kalansari1@hmc.org.qa

Locations
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Qatar
Hamad Medical Corporation Recruiting
Doha, Qatar, 3050
Contact: Rafah Sayyed, MD    +97455747045    ralsayyed@hamad.qa   
Sponsors and Collaborators
Hamad Medical Corporation
Investigators
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Principal Investigator: Khalid Al ansari, FRCP Hamad Medical Corporation
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: DR. KHALID AL-ANSARI, Director of Pediatrics Emergency Centeres, Hamad Medical Corporation
ClinicalTrials.gov Identifier: NCT03523221    
Other Study ID Numbers: 171661/17
First Posted: May 14, 2018    Key Record Dates
Last Update Posted: August 31, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by DR. KHALID AL-ANSARI, Hamad Medical Corporation:
Mild -Moderate Anaphylaxis
Additional relevant MeSH terms:
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Anaphylaxis
Shock
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pathologic Processes
Dexamethasone
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents