Asthma
Conditions
Keywords
Status asthmaticus, Asthma exacerbation, Epinephrine, Adjunctive therapy
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.
Interventions
DRUGIM 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.
OTHERNo intervention
A sham band-aid will be applied to the anterior thigh of subjects who are randomized to the no intervention group.
Sponsors
University of Louisville
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Percent of Predicted Peak Expiratory Flow Rate (PEFR) at t15 | 15 minutes after the study intervention | Change in percent of predicted Peak Expiratory Flow Rate (PEFR) 15 minutes after the study intervention (t15). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disposition | 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. |
| Change in Percent of Predicted PEFR at t120 | 120 minutes after the study intervention | 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 120 minutes after the study intervention | breaths per minute at t120 minutes compared to baseline |
| Heart Rate at t120 | up to 120 minutes after the study intervention | Heart rate at t120 minutes in beats per minute (BPM) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 25 |
| 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. | 24 |
| Total | 49 |
Baseline characteristics
| Characteristic | No Intervention | Total | IM Epinephrine 1:1000 |
|---|---|---|---|
| Age, Categorical <=18 years | 24 Participants | 49 Participants | 25 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 10.58 years STANDARD_DEVIATION 2.76 | 10.29 years STANDARD_DEVIATION 3.1 | 10.00 years STANDARD_DEVIATION 3.42 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 17 Participants | 34 Participants | 17 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) White | 6 Participants | 11 Participants | 5 Participants |
| Region of Enrollment United States | 24 Participants | 49 Participants | 25 Participants |
| Sex: Female, Male Female | 12 Participants | 22 Participants | 10 Participants |
| Sex: Female, Male Male | 12 Participants | 27 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 24 |
| other Total, other adverse events | 0 / 25 | 0 / 24 |
| serious Total, serious adverse events | 0 / 25 | 0 / 24 |
Outcome results
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).
Time frame: 15 minutes after the study intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IM Epinephrine 1:1000 | Change in Percent of Predicted Peak Expiratory Flow Rate (PEFR) at t15 | 59.56 percentage of predicted | Standard Deviation 17.11 |
| No Intervention | Change in Percent of Predicted Peak Expiratory Flow Rate (PEFR) at t15 | 52.45 percentage of predicted | Standard Deviation 13.73 |
Secondary
Breaths Per Minute at t120
breaths per minute at t120 minutes compared to baseline
Time frame: breaths per minute 120 minutes after the study intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IM Epinephrine 1:1000 | Breaths Per Minute at t120 | 24.29 breaths per minute | Standard Deviation 5.99 |
| No Intervention | Breaths Per Minute at t120 | 29.29 breaths per minute | Standard Deviation 7.96 |
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
Time frame: 120 minutes after the study intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IM Epinephrine 1:1000 | Change in Percent of Predicted PEFR at t120 | 64.51 percentage of PEFR | Standard Deviation 21.68 |
| No Intervention | Change in Percent of Predicted PEFR at t120 | 56.18 percentage of PEFR | Standard Deviation 13.36 |
Secondary
Disposition
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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IM Epinephrine 1:1000 | Disposition | 15 Participants |
| No Intervention | Disposition | 12 Participants |
Secondary
Heart Rate at t120
Heart rate at t120 minutes in beats per minute (BPM)
Time frame: up to 120 minutes after the study intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IM Epinephrine 1:1000 | Heart Rate at t120 | 147.65 Beats per minute | Standard Deviation 13.91 |
| No Intervention | Heart Rate at t120 | 142.29 Beats per minute | Standard Deviation 16.3 |