Intramuscular Epinephrine as an Adjunctive Treatment for Severe Pediatric Asthma Exacerbation

Phase 4

Completed

• Conditions: Asthma
• Interventions: Other: No intervention

• Registration Number: NCT01705964
• Lead Sponsor: University of Louisville

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-10-09
• Study First Submitted QC: 2012-10-11
• Study First Posted: 2012-10-12
• Study Start: 2013-06
• Primary Completion: 2018-04-30
• Study Completion: 2018-04-30
• Results First Submitted: 2020-05-06
• Status Verified: 2021-06
• Results First Submitted QC: 2021-06-12
• Last Update Submitted: 2021-06-12
• Results First Posted: 2021-07-06
• Last Update Posted: 2021-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No intervention	No intervention	A sham band-aid will be applied to the anterior thigh of subjects who are randomized to the no intervention group.

Primary Outcome Measures

Name	Time	Method
Change in Percent of Predicted Peak Expiratory Flow Rate (PEFR) at t15	15 minutes after the study intervention	Change in percent of predicted Peak Expiratory Flow Rate (PEFR) 15 minutes after the study intervention (t15).

Secondary Outcome Measures

Name	Time	Method
Disposition	At the time a dispostion from the ED is completed (usually within 4 hours of the study intervention)	Disposition from the ED or rates of discharge.
Change in Percent of Predicted PEFR at t120	120 minutes after the study intervention	Change in percent of predicted Peak Expiratory Flow Rate (PEFR) 120 minutes after study intervention compared to baseline
Breaths Per Minute at t120	breaths per minute 120 minutes after the study intervention	breaths per minute at t120 minutes compared to baseline
Heart Rate at t120	up to 120 minutes after the study intervention	Heart rate at t120 minutes in beats per minute (BPM)

Trial Locations

Locations (1)

Kosair Children's Hospital; 🇺🇸 Louisville, Kentucky, United States