Intramuscular Epinephrine as an Adjunctive Treatment for Severe Pediatric Asthma Exacerbation

NCT01705964 | Completed Phase 4 Results

• 1 other identifier: Caperell-Epi-001
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

Status asthmaticus; Asthma exacerbation; Epinephrine; Adjunctive therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Disposition

  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

  120 minutes after the study intervention

• Breaths Per Minute at t120

  breaths per minute 120 minutes after the study intervention

• Heart Rate at t120

  up to 120 minutes after the study intervention

Study Arms (2)

IM epinephrine 1:1000

EXPERIMENTAL

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

No intervention

SHAM COMPARATOR

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

Other: No intervention

Interventions

IM epinephrine 1:1000 DRUG

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.

IM epinephrine 1:1000

No intervention OTHER

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

No intervention

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age greater than 6 years and less than 18 years
• Pre-existing diagnosis of asthma
• Presenting to the ED with an asthma exacerbation

You may not qualify if:

• History of chronic lung or upper airway disease other than asthma
• History significant, uncorrected congenital heart disease or cardiac arrhythmia
• History of thyroid disease
• Impending respiratory failure
• Allergy to epinephrine
• Pregnancy
• PEFR\>60% of predicted and clinical asthma score less than 8

Sponsors & Collaborators

• University of Louisville: lead

Study Sites (1)

Kosair Children's Hospital

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Asthma; Status Asthmaticus

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Dr. Kerry Caperell
• Organization: University of Louisville

k0cape01@louisville.edu

502-629-7212

Study Officials

• Kerry Caperell, MD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: October 9, 2012
• First Posted: October 12, 2012
• Study Start: June 1, 2013
• Primary Completion: April 30, 2018
• Study Completion: April 30, 2018
• Last Updated: July 6, 2021
• Results First Posted: July 6, 2021

Record last verified: 2021-06

Locations

US (1)