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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kerry Caperell, MD | University of Louisville | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kosair Children's Hospital | Louisville | Kentucky | 40202 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| FG001 | No Intervention | A sham band-aid will be applied to the anterior thigh of subjects who are randomized to the no intervention group. No intervention: A sham band-aid will be applied to the anterior thigh of subjects who are randomized to the no intervention group. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Mean | Standard Deviation | percentage of predicted | 15 minutes after the study intervention |
|
4 years 10 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kerry Caperell | University of Louisville | 502-629-7212 | k0cape01@louisville.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 16, 2012 | Sep 26, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D013224 | Status Asthmaticus |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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|
| No intervention | Other | A sham band-aid will be applied to the anterior thigh of subjects who are randomized to the no intervention group. |
|
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 |
| BG001 | No Intervention | A sham band-aid will be applied to the anterior thigh of subjects who are randomized to the no intervention group. No intervention: A sham band-aid will be applied to the anterior thigh of subjects who are randomized to the no intervention group. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 |
| No Intervention |
A sham band-aid will be applied to the anterior thigh of subjects who are randomized to the no intervention group. No intervention: A sham band-aid will be applied to the anterior thigh of subjects who are randomized to the no intervention group. |
|
|
| Secondary | Disposition | Disposition from the ED or rates of discharge. | Posted | Count of Participants | Participants | At the time a dispostion from the ED is completed (usually within 4 hours of the study intervention) |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | percentage of PEFR | 120 minutes after the study intervention |
|
|
|
| Secondary | Breaths Per Minute at t120 | breaths per minute at t120 minutes compared to baseline | Posted | Mean | Standard Deviation | breaths per minute | breaths per minute 120 minutes after the study intervention |
|
|
|
| Secondary | Heart Rate at t120 | Heart rate at t120 minutes in beats per minute (BPM) | Posted | Mean | Standard Deviation | Beats per minute | up to 120 minutes after the study intervention |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | No Intervention | A sham band-aid will be applied to the anterior thigh of subjects who are randomized to the no intervention group. No intervention: A sham band-aid will be applied to the anterior thigh of subjects who are randomized to the no intervention group. | 0 | 24 | 0 | 24 | 0 | 24 |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |