Intramuscular Epinephrine as an Adjunctive Treatment for Severe Pediatric Asthma Exacerbation
NCT ID: NCT01705964
Last Updated: 2021-07-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
49 participants
INTERVENTIONAL
2013-06-30
2018-04-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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IM epinephrine 1:1000
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.
IM epinephrine 1:1000
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.
No intervention
A sham band-aid will be applied to the anterior thigh of subjects who are randomized to the no intervention group.
No intervention
A sham band-aid will be applied to the anterior thigh of subjects who are randomized to the no intervention group.
Interventions
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IM epinephrine 1:1000
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.
No intervention
A sham band-aid will be applied to the anterior thigh of subjects who are randomized to the no intervention group.
Eligibility Criteria
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Inclusion Criteria
2. Pre-existing diagnosis of asthma
3. Presenting to the ED with an asthma exacerbation
Exclusion Criteria
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
6 Years
17 Years
ALL
No
Sponsors
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University of Louisville
OTHER
Responsible Party
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Kerry Caperell
Assistant Professor of Pediatrics
Principal Investigators
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Kerry Caperell, MD
Role: PRINCIPAL_INVESTIGATOR
University of Louisville
Locations
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Kosair Children's Hospital
Louisville, Kentucky, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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Caperell-Epi-001
Identifier Type: -
Identifier Source: org_study_id
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