At a glance
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Intramuscular Epinephrine as an Adjunctive Treatment for Severe Pediatric Asthma Exacerbation
In Brief
A Phase 4 clinical trial evaluating IM epinephrine 1:1000 and No intervention for Asthma. Completed, enrolled 49 participants across 1 site.
Detailed Summary
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.
Study Details
Timeline
Interventions
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.
A sham band-aid will be applied to the anterior thigh of subjects who are randomized to the no intervention group.