Intramuscular Epinephrine as an Adjunctive Treatment for Severe Pediatric Asthma Exacerbation

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 Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: IM epinephrine 1:1000; Other: No intervention

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Kosair Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Sham Comparator: No intervention; A sham band-aid will be applied to the anterior thigh of subjects who are randomized to the no intervention group.	Other: No intervention; A sham band-aid will be applied to the anterior thigh of subjects who are randomized to the no intervention group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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
Breaths Per Minute at t120	breaths per minute at t120 minutes compared to baseline	breaths per minute 120 minutes after the study intervention
Heart Rate at t120	Heart rate at t120 minutes in beats per minute (BPM)	up to 120 minutes after the study intervention

Collaborators and Investigators

• Sponsor: University of Louisville
• Investigators: Principal Investigator: Kerry Caperell, MD, University of Louisville

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): April 30, 2018
• Study Completion (Actual): April 30, 2018

Study Registration Dates

• First Submitted: October 9, 2012
• First Submitted That Met QC Criteria: October 11, 2012
• First Posted (Estimate): October 12, 2012

Study Record Updates

• Last Update Posted (Actual): July 6, 2021
• Last Update Submitted That Met QC Criteria: June 12, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Epinephrine; Adjunctive therapy; Asthma exacerbation; Status asthmaticus
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Epinephrine
• Other Study ID Numbers: Caperell-Epi-001