Dexamethasone Tolerability in the Treatment of Acute Asthma in Children

Study Overview
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Brief Summary
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The purpose of this study is to assess whether smaller volumes of oral dexamethasone result in better tolerability, specifically less vomiting, in pediatric patients during an acute asthma exacerbation.

Official Title
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Dexamethasone Tolerability in the Treatment of Acute Asthma in Children

Conditions
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Asthma

Intervention / Treatment
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* Drug: Ora Sweet
* Drug: Dexamethasone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: acute asthma exacerbation requiring oral systemic corticosteroids for management Exclusion Criteria: preference for pills over liquid formulation history of Nissen fundoplication surgery needed immediate airway intervention require oral medications to be given via a G or J tube if patient care would be compromised enrolled in the study on a previous visit.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 10 mg/mL Unsweetened Formulation<br>no prior vomiting | Drug: Dexamethasone<br> <br> |
| Experimental: 1 mg/mL Ora Sweet Formulation<br>no prior vomiting | Drug: Ora Sweet<br>* A pharmaceutical suspending vehicle and flavouring agent added to the dexamethasone. All arms received the same amount of dexamethasone based on the child's weight, only in different volumes.<br>Drug: Dexamethasone<br> <br> |
| Active Comparator: 10 mg/mL Unsweetened with prior vomiting<br>with prior vomiting | Drug: Dexamethasone<br> <br> |
| Experimental: 1 mg/mL Ora Sweet with prior vomiting<br>with prior vomiting | Drug: Ora Sweet<br>* A pharmaceutical suspending vehicle and flavouring agent added to the dexamethasone. All arms received the same amount of dexamethasone based on the child's weight, only in different volumes.<br>Drug: Dexamethasone<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective of this study was to assess whether smaller volumes of oral dexamethasone resulted in better tolerability, specifically less vomiting, in pediatric patients with an acute exacerbation of asthma. |  | During Emergency Department visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate asthma symptom control post emergency room visit for acute asthma exacerbation. |  | 7-14 days following emergency dept visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pediatric, dexamethasone, management, corticosteroids, asthma