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Intramuscular Epinephrine as an Adjunctive Treatment for Severe Pediatric Asthma Exacerbation

Primary Purpose

Asthma

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
IM epinephrine 1:1000
No intervention
Sponsored by
University of Louisville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Status asthmaticus, Asthma exacerbation, Epinephrine, Adjunctive therapy

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kosair Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

IM epinephrine 1:1000

No intervention

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Disposition
Disposition from the ED or rates of discharge.
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
Breaths Per Minute at t120
breaths per minute at t120 minutes compared to baseline
Heart Rate at t120
Heart rate at t120 minutes in beats per minute (BPM)

Full Information

First Posted
October 9, 2012
Last Updated
June 12, 2021
Sponsor
University of Louisville
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1. Study Identification

Unique Protocol Identification Number
NCT01705964
Brief Title
Intramuscular Epinephrine as an Adjunctive Treatment for Severe Pediatric Asthma Exacerbation
Official Title
Intramuscular Epinephrine as an Adjunctive Treatment for Severe Pediatric Asthma Exacerbation
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
April 30, 2018 (Actual)
Study Completion Date
April 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Louisville

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Status asthmaticus, Asthma exacerbation, Epinephrine, Adjunctive therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IM epinephrine 1:1000
Arm Type
Experimental
Arm Description
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.
Arm Title
No intervention
Arm Type
Sham Comparator
Arm Description
A sham band-aid will be applied to the anterior thigh of subjects who are randomized to the no intervention group.
Intervention Type
Drug
Intervention Name(s)
IM epinephrine 1:1000
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
No intervention
Intervention Description
A sham band-aid will be applied to the anterior thigh of subjects who are randomized to the no intervention group.
Primary Outcome Measure Information:
Title
Change in Percent of Predicted Peak Expiratory Flow Rate (PEFR) at t15
Description
Change in percent of predicted Peak Expiratory Flow Rate (PEFR) 15 minutes after the study intervention (t15).
Time Frame
15 minutes after the study intervention
Secondary Outcome Measure Information:
Title
Disposition
Description
Disposition from the ED or rates of discharge.
Time Frame
At the time a dispostion from the ED is completed (usually within 4 hours of the study intervention)
Title
Change in Percent of Predicted PEFR at t120
Description
Change in percent of predicted Peak Expiratory Flow Rate (PEFR) 120 minutes after study intervention compared to baseline
Time Frame
120 minutes after the study intervention
Title
Breaths Per Minute at t120
Description
breaths per minute at t120 minutes compared to baseline
Time Frame
breaths per minute 120 minutes after the study intervention
Title
Heart Rate at t120
Description
Heart rate at t120 minutes in beats per minute (BPM)
Time Frame
up to 120 minutes after the study intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age greater than 6 years and less than 18 years Pre-existing diagnosis of asthma Presenting to the ED with an asthma exacerbation Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kerry Caperell, MD
Organizational Affiliation
University of Louisville
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kosair Children's Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States

12. IPD Sharing Statement

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Intramuscular Epinephrine as an Adjunctive Treatment for Severe Pediatric Asthma Exacerbation

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