Trial Outcomes & Findings for Intramuscular Epinephrine as an Adjunctive Treatment for Severe Pediatric Asthma Exacerbation (NCT NCT01705964)
NCT ID: NCT01705964
Last Updated: 2021-07-06
Results Overview
Change in percent of predicted Peak Expiratory Flow Rate (PEFR) 15 minutes after the study intervention (t15).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
49 participants
Primary outcome timeframe
15 minutes after the study intervention
Results posted on
2021-07-06
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
24
|
|
Overall Study
COMPLETED
|
25
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intramuscular Epinephrine as an Adjunctive Treatment for Severe Pediatric Asthma Exacerbation
Baseline characteristics by cohort
| Measure |
IM Epinephrine 1:1000
n=25 Participants
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.
|
No Intervention
n=24 Participants
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.
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
25 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
10.00 years
STANDARD_DEVIATION 3.42 • n=5 Participants
|
10.58 years
STANDARD_DEVIATION 2.76 • n=7 Participants
|
10.29 years
STANDARD_DEVIATION 3.10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 15 minutes after the study interventionChange in percent of predicted Peak Expiratory Flow Rate (PEFR) 15 minutes after the study intervention (t15).
Outcome measures
| Measure |
IM Epinephrine 1:1000
n=25 Participants
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.
|
No Intervention
n=24 Participants
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.
|
|---|---|---|
|
Change in Percent of Predicted Peak Expiratory Flow Rate (PEFR) at t15
|
59.56 percentage of predicted
Standard Deviation 17.11
|
52.45 percentage of predicted
Standard Deviation 13.73
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
IM Epinephrine 1:1000
n=25 Participants
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.
|
No Intervention
n=24 Participants
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.
|
|---|---|---|
|
Disposition
|
15 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: 120 minutes after the study interventionChange in percent of predicted Peak Expiratory Flow Rate (PEFR) 120 minutes after study intervention compared to baseline
Outcome measures
| Measure |
IM Epinephrine 1:1000
n=25 Participants
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.
|
No Intervention
n=24 Participants
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.
|
|---|---|---|
|
Change in Percent of Predicted PEFR at t120
|
64.51 percentage of PEFR
Standard Deviation 21.68
|
56.18 percentage of PEFR
Standard Deviation 13.36
|
SECONDARY outcome
Timeframe: breaths per minute 120 minutes after the study interventionbreaths per minute at t120 minutes compared to baseline
Outcome measures
| Measure |
IM Epinephrine 1:1000
n=25 Participants
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.
|
No Intervention
n=24 Participants
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.
|
|---|---|---|
|
Breaths Per Minute at t120
|
24.29 breaths per minute
Standard Deviation 5.99
|
29.29 breaths per minute
Standard Deviation 7.96
|
SECONDARY outcome
Timeframe: up to 120 minutes after the study interventionHeart rate at t120 minutes in beats per minute (BPM)
Outcome measures
| Measure |
IM Epinephrine 1:1000
n=25 Participants
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.
|
No Intervention
n=24 Participants
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.
|
|---|---|---|
|
Heart Rate at t120
|
147.65 Beats per minute
Standard Deviation 13.91
|
142.29 Beats per minute
Standard Deviation 16.30
|
Adverse Events
IM Epinephrine 1:1000
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place