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Trial record 12 of 35 for:    "Bronchial Disease" | "Epinephrine"

Intramuscular Epinephrine as an Adjunctive Treatment for Severe Pediatric Asthma Exacerbation

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ClinicalTrials.gov Identifier: NCT01705964
Recruitment Status : Completed
First Posted : October 12, 2012
Last Update Posted : May 1, 2018
Sponsor:
Information provided by (Responsible Party):
Kerry Caperell, University of Louisville

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.


Condition or disease Intervention/treatment Phase
Asthma Drug: IM epinephrine 1:1000 Other: No intervention Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intramuscular Epinephrine as an Adjunctive Treatment for Severe Pediatric Asthma Exacerbation
Study Start Date : June 2013
Actual Primary Completion Date : April 30, 2018
Actual Study Completion Date : April 30, 2018


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.




Primary Outcome Measures :
  1. Change in percent of predicted Peak Expiratory Flow Rate (PEFR) or clinical asthma score 15 minutes after the study intervention (t15). [ Time Frame: During ED stay ]
    15 minutes after the study intervention


Secondary Outcome Measures :
  1. 1. Change in percent of predicted PEFR/CAS at t15 [ Time Frame: 15 minutes after the study intervention ]
  2. 2. Disposition [ Time Frame: At the time a dispostion from the ED is completed (usually within 4 hours of the study intervention) ]
  3. 3. Change in percent of predicted PEFR/CAS at t30, t60, t90 and t120 [ Time Frame: Up to 120 minutes after the study intervention ]
  4. 4. Change in percent of predicted PEFR/CAS at t30, t60, t90 and t120 [ Time Frame: Up to120 minutes after the study intervention ]
  5. 5. Change in respiratory rate at t15, t30, t60, t90 and t120 [ Time Frame: Up to120 minutes after the study intervention ]
  6. 6. Change in heart rate at t15, t30, t60, t90 and t120 [ Time Frame: Up to120 minutes after the study intervention ]
  7. 7. Need for supplemental oxygen at t60, t90 and t120 (defined as a room air pulse oximetry of <93%) [ Time Frame: Up to120 minutes after the study intervention ]
  8. 8. Need for albuterol at t60, t90 and t120 [ Time Frame: Up to120 minutes after the study intervention ]
  9. 9. Number of hours of albuterol therapy in the emergency department [ Time Frame: Up to 6 hours after the study intervention ]
  10. 10. ED length of stay [ Time Frame: Up to 6 hours after the study intervention ]


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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01705964


Locations
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United States, Kentucky
Kosair Children's Hospital
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
University of Louisville
Investigators
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Principal Investigator: Kerry Caperell, MD University of Louisville

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Responsible Party: Kerry Caperell, Assistant Professor of Pediatrics, University of Louisville
ClinicalTrials.gov Identifier: NCT01705964     History of Changes
Other Study ID Numbers: Caperell-Epi-001
First Posted: October 12, 2012    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: April 2018

Keywords provided by Kerry Caperell, University of Louisville:
Status asthmaticus
Asthma exacerbation
Epinephrine
Adjunctive therapy

Additional relevant MeSH terms:
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Bronchial Diseases
Epinephrine
Racepinephrine
Epinephryl borate
Asthma
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents