Intramuscular Epinephrine as an Adjunctive Treatment for Severe Pediatric Asthma Exacerbation
| Status: | Completed |
|---|---|
| Conditions: | Asthma |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 6 - 17 |
| Updated: | 5/3/2018 |
| Start Date: | June 2013 |
| End Date: | April 30, 2018 |
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.
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.
Inclusion Criteria:
1. Age greater than 6 years and less than 18 years
2. Pre-existing diagnosis of asthma
3. Presenting to the ED with an asthma exacerbation
Exclusion Criteria:
1. History of chronic lung or upper airway disease other than asthma
2. History significant, uncorrected congenital heart disease or cardiac arrhythmia
3. History of thyroid disease
4. Impending respiratory failure
5. Allergy to epinephrine
6. Pregnancy
7. PEFR>60% of predicted and clinical asthma score less than 8
We found this trial at
1
site
231 E Chestnut St
Louisville, Kentucky 40202
Louisville, Kentucky 40202
(502) 629-6000
Principal Investigator: Kerry Caperell, MD
Phone: 502-629-7212
Kosair Children's Hospital For more than a century, Kosair Children's Hospital and its predecessor hospitals...
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