Intramuscular Epinephrine as an Adjunctive Treatment for Severe Pediatric Asthma Exacerbation

Asthma Clinical Trial

Official title:

Intramuscular Epinephrine as an Adjunctive Treatment for Severe Pediatric Asthma Exacerbation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01705964
• Other study ID #: Caperell-Epi-001
• Status: Completed
• Phase: Phase 4
• Start date: June 2013
• Est. completion date: April 30, 2018

Study information

• Verified date: June 2021
• Source: University of Louisville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: April 30, 2018
• Est. primary completion date: April 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• 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.

Other:
• No intervention
A sham band-aid will be applied to the anterior thigh of subjects who are randomized to the no intervention group.

Locations

Country	Name	City	State
United States	Kosair Children's Hospital	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
University of Louisville

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	15 minutes after the study intervention
Secondary	Disposition	Disposition from the ED or rates of discharge.	At the time a dispostion from the ED is completed (usually within 4 hours of the study intervention)
Secondary	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	120 minutes after the study intervention
Secondary	Breaths Per Minute at t120	breaths per minute at t120 minutes compared to baseline	breaths per minute 120 minutes after the study intervention
Secondary	Heart Rate at t120	Heart rate at t120 minutes in beats per minute (BPM)	up to 120 minutes after the study intervention