Intramuscular Epinephrine as an Adjunctive Treatment for Severe Pediatric Asthma Exacerbation

Study Overview
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Brief Summary
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Project Aim: To determine if intramuscular epinephrine is an effective adjunct to inhaled bronchodilators (β2 agonists) for children with severe asthma exacerbation. Hypothesis: IM epinephrine is an efficacious adjunct to inhaled bronchodilators (β2 agonists) for children with severe asthma exacerbation. Intervention: Subjects will be randomly assigned (50% chance) to receive a weight based dose of IM epinephrine 1:1000 or no adjunctive medication. The dose will be 0.2 mg for subjects 20-30 kg and 0.3 mg for subjects greater than 30 kg. This will be injected intramuscularly by an ED nurse into the anterior thigh muscles of the subject using a 1 ml syringe and a 23 gauge one inch needle. In addition to the study intervention, the standardized treatment pathway based on the current asthma guidelines in use at the investigator's center will be utilized. This pathway includes nebulized albuterol, ipratropium bromide, and systemic corticosteroids. The duration and dosages of these other interventions will be administered at the discretion of the treating provider.

Official Title
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Intramuscular Epinephrine as an Adjunctive Treatment for Severe Pediatric Asthma Exacerbation

Conditions
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Asthma

Intervention / Treatment
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* Drug: IM epinephrine 1:1000
* Other: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age greater than 6 years and less than 18 years Pre-existing diagnosis of asthma Presenting to the ED with an asthma exacerbation Exclusion Criteria: History of chronic lung or upper airway disease other than asthma History significant, uncorrected congenital heart disease or cardiac arrhythmia History of thyroid disease Impending respiratory failure Allergy to epinephrine Pregnancy PEFR>60% of predicted and clinical asthma score less than 8

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 17 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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IM epinephrine 1:1000<br>IM epinephrine 1:1000. The dose will be 0.2 mg for subjects 20-30 kg and 0.3 mg for subjects greater than 30 kg. This will be injected intramuscularly by an ED nurse into the anterior thigh muscles of the subject using a 1 ml syringe and a 23 gauge one inch needle. | Drug: IM epinephrine 1:1000<br>* IM epinephrine 1:1000. The dose will be 0.2 mg for subjects 20-30 kg and 0.3 mg for subjects greater than 30 kg. This will be injected intramuscularly by an ED nurse into the anterior thigh muscles of the subject using a 1 ml syringe and a 23 gauge one inch needle.<br>|
| Sham Comparator: No intervention<br>A sham band-aid will be applied to the anterior thigh of subjects who are randomized to the no intervention group. | Other: No intervention<br>* A sham band-aid will be applied to the anterior thigh of subjects who are randomized to the no intervention group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Percent of Predicted Peak Expiratory Flow Rate (PEFR) at t15 | Change in percent of predicted Peak Expiratory Flow Rate (PEFR) 15 minutes after the study intervention (t15). | 15 minutes after the study intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disposition | Disposition from the ED or rates of discharge. | At the time a dispostion from the ED is completed (usually within 4 hours of the study intervention) | 
| Change in Percent of Predicted PEFR at t120 | Change in percent of predicted Peak Expiratory Flow Rate (PEFR) 120 minutes after study intervention compared to baseline | 120 minutes after the study intervention | 
| Breaths Per Minute at t120 | breaths per minute at t120 minutes compared to baseline | breaths per minute 120 minutes after the study intervention | 
| Heart Rate at t120 | Heart rate at t120 minutes in beats per minute (BPM) | up to 120 minutes after the study intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Status asthmaticus, Asthma exacerbation, Epinephrine, Adjunctive therapy