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Completed

NCT Number: NCT01705964

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases Status Asthmaticus

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kosair Children's Hospital

Louisville, Kentucky, 40202, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

No intervention

Other

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

Primary outcomes

  1. Change in Percent of Predicted Peak Expiratory Flow Rate (PEFR) at t15

    Time frame: 15 minutes after the study intervention

    Change in percent of predicted Peak Expiratory Flow Rate (PEFR) 15 minutes after the study intervention (t15).

Secondary outcomes

  1. Disposition

    Time frame: 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.

  2. Change in Percent of Predicted PEFR at t120

    Time frame: 120 minutes after the study intervention

    Change in percent of predicted Peak Expiratory Flow Rate (PEFR) 120 minutes after study intervention compared to baseline

  3. Breaths Per Minute at t120

    Time frame: breaths per minute 120 minutes after the study intervention

    breaths per minute at t120 minutes compared to baseline

  4. Heart Rate at t120

    Time frame: up to 120 minutes after the study intervention

    Heart rate at t120 minutes in beats per minute (BPM)

Sponsors and collaborators

Lead sponsor

University of Louisville

Other

Registry information

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Oct 12, 2012
Registry last updated
Jul 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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