Trial Outcomes & Findings for Volumes of Administration for Intranasal Midazolam (NCT NCT01948908)
NCT ID: NCT01948908
Last Updated: 2019-04-30
Results Overview
This outcome is designed to examine time to onset of minimal sedation, defined as a University of Michigan Sedation Score (UMSS) of 1.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
99 participants
Primary outcome timeframe
20 minutes
Results posted on
2019-04-30
Participant Flow
Participant milestones
| Measure |
200 mcL VOA
Intranasal midazolam administered in 200 mcL VOA
Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD).
|
500 mcL VOA
Intranasal midazolam administered in 500 mcL VOA.
Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD).
|
1000 mcL VOA
Intranasal midazolam administered in 1000 mcL VOA.
Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD).
|
|---|---|---|---|
|
Overall Study
STARTED
|
33
|
33
|
33
|
|
Overall Study
COMPLETED
|
32
|
33
|
31
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
2
|
Reasons for withdrawal
| Measure |
200 mcL VOA
Intranasal midazolam administered in 200 mcL VOA
Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD).
|
500 mcL VOA
Intranasal midazolam administered in 500 mcL VOA.
Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD).
|
1000 mcL VOA
Intranasal midazolam administered in 1000 mcL VOA.
Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD).
|
|---|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
2
|
Baseline Characteristics
Volumes of Administration for Intranasal Midazolam
Baseline characteristics by cohort
| Measure |
200 mcL VOA
n=32 Participants
Intranasal midazolam administered in 200 mcL VOA
Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD).
|
500 mcL VOA
n=33 Participants
Intranasal midazolam administered in 500 mcL VOA.
Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD).
|
1000 mcL VOA
n=31 Participants
Intranasal midazolam administered in 1000 mcL VOA.
Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD).
|
Total
n=96 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
3 years
n=93 Participants
|
2.7 years
n=4 Participants
|
2.7 years
n=27 Participants
|
2.9 years
n=483 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
32 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=93 Participants
|
25 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
64 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
22 participants
n=93 Participants
|
25 participants
n=4 Participants
|
25 participants
n=27 Participants
|
72 participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic, White
|
6 participants
n=93 Participants
|
5 participants
n=4 Participants
|
5 participants
n=27 Participants
|
16 participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic, Black
|
3 participants
n=93 Participants
|
2 participants
n=4 Participants
|
1 participants
n=27 Participants
|
6 participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic, Other
|
1 participants
n=93 Participants
|
1 participants
n=4 Participants
|
0 participants
n=27 Participants
|
2 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: 20 minutesThis outcome is designed to examine time to onset of minimal sedation, defined as a University of Michigan Sedation Score (UMSS) of 1.
Outcome measures
| Measure |
200 mcL VOA
n=32 Participants
Intranasal midazolam administered in 200 mcL VOA
Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD).
|
500 mcL VOA
n=33 Participants
Intranasal midazolam administered in 500 mcL VOA.
Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD).
|
1000 mcL VOA
n=31 Participants
Intranasal midazolam administered in 1000 mcL VOA.
Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD).
|
|---|---|---|---|
|
Median Time (Minutes) After Administration of Intranasal Midazolam Until Patient Achieves Minimal Sedation
|
4.7 minutes
Interval 3.8 to 5.4
|
4.3 minutes
Interval 3.9 to 4.9
|
5.2 minutes
Interval 4.6 to 7.0
|
SECONDARY outcome
Timeframe: 60 minutesThe Observational Scale of Behavioral Distress - revised (OSBD-r) is an eight-factor, weighted observational scale used to measure distress associated with medical procedures in children 1 to 20 years of age. The total OSBD-r score is the sum of the OSBD-r scores for predetermined clinically relevant phases of the procedure, with each phase assigned a score from 0 to 23.5 (0=no distress, 23.5=maximum distress), based on the frequency and types of behaviors observed during a pre-determined number of 15-second intervals during each phase.
Outcome measures
| Measure |
200 mcL VOA
n=32 Participants
Intranasal midazolam administered in 200 mcL VOA
Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD).
|
500 mcL VOA
n=33 Participants
Intranasal midazolam administered in 500 mcL VOA.
Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD).
|
1000 mcL VOA
n=31 Participants
Intranasal midazolam administered in 1000 mcL VOA.
Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD).
|
|---|---|---|---|
|
Observational Scale of Behavioral Distress - Revised
|
6.06 units
Interval 3.68 to 8.44
|
7.90 units
Interval 4.95 to 10.85
|
8.56 units
Interval 5.75 to 11.37
|
SECONDARY outcome
Timeframe: 60 minutesThis outcome is designed to examine MD satisfaction with ease of administration of intranasal medication - physicians who expressed that they were satisfied or very satisfied with ease of medication administration will be counted.
Outcome measures
| Measure |
200 mcL VOA
n=32 Participants
Intranasal midazolam administered in 200 mcL VOA
Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD).
|
500 mcL VOA
n=33 Participants
Intranasal midazolam administered in 500 mcL VOA.
Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD).
|
1000 mcL VOA
n=31 Participants
Intranasal midazolam administered in 1000 mcL VOA.
Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD).
|
|---|---|---|---|
|
Number of Patients With Physicians Who Were Satisfied or Very Satisfied With Ease of Medication Administration
|
13 participants
|
30 participants
|
30 participants
|
Adverse Events
200 mcL VOA
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
500 mcL VOA
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
1000 mcL VOA
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
200 mcL VOA
n=32 participants at risk
Intranasal midazolam administered in 200 mcL VOA
Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD).
|
500 mcL VOA
n=33 participants at risk
Intranasal midazolam administered in 500 mcL VOA.
Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD).
|
1000 mcL VOA
n=31 participants at risk
Intranasal midazolam administered in 1000 mcL VOA.
Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD).
|
|---|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/32 • From time of administration of intranasal midazolam until emergency department discharge, an average of 1 hour.
|
6.1%
2/33 • From time of administration of intranasal midazolam until emergency department discharge, an average of 1 hour.
|
3.2%
1/31 • From time of administration of intranasal midazolam until emergency department discharge, an average of 1 hour.
|
|
Surgical and medical procedures
Inadequate sedation
|
0.00%
0/32 • From time of administration of intranasal midazolam until emergency department discharge, an average of 1 hour.
|
6.1%
2/33 • From time of administration of intranasal midazolam until emergency department discharge, an average of 1 hour.
|
0.00%
0/31 • From time of administration of intranasal midazolam until emergency department discharge, an average of 1 hour.
|
Additional Information
Daniel S. Tsze
Columbia University College of Physicians and Surgeons
Phone: 212-305-9825
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place