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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
49
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.
Kosair Children's Hospital
Louisville, Kentucky, United States
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).
Time frame: 15 minutes after the study intervention
Disposition
Disposition from the ED or rates of discharge.
Time frame: 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
Time frame: 120 minutes after the study intervention
Breaths Per Minute at t120
breaths per minute at t120 minutes compared to baseline
Time frame: breaths per minute 120 minutes after the study intervention
Heart Rate at t120
Heart rate at t120 minutes in beats per minute (BPM)
Time frame: up to 120 minutes after the study intervention
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