drugset / Trial / NCT01705964

Intramuscular Epinephrine as an Adjunctive Treatment for Severe Pediatric Asthma Exacerbation

NCT01705964

Phase 4 Completed 49 enrolled University of Louisville
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2013-06
Primary completion
2018-04-30
Completion
2018-04-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Epinephrine Other / unclassified 0.2 mg Intramuscular
Subject Epinephrine Other / unclassified 0.3 mg Intramuscular

Indications