Trial Outcomes & Findings for Dose-Finding Study of Intranasal Midazolam for Procedural Sedation in Children (NCT NCT04586504)
NCT ID: NCT04586504
Last Updated: 2025-08-06
Results Overview
The Pediatric Sedation State Scale (PSSS) is scored from 0 to 5, representing a continuum of sedation that spans from over-sedation associated with changes in vital signs (0) to inadequate sedation (5).
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
101 participants
Primary outcome timeframe
From study drug administration until procedure finished (approximately 60 minutes)
Results posted on
2025-08-06
Participant Flow
Participant milestones
| Measure |
0.2 mg/kg
Children in a single urban pediatric emergency department (ED) randomized to receive IN midazolam at 0.2 mg/kg.
Intranasal midazolam: 5 mg/mL concentration of midazolam. Maximum dose = 10 mg. Administered using a mucosal atomization device.
|
0.3 mg/kg
Children in a single urban pediatric emergency department (ED) randomized to receive IN midazolam at 0.3 mg/kg.
Intranasal midazolam: 5 mg/mL concentration of midazolam. Maximum dose = 10 mg. Administered using a mucosal atomization device.
|
0.4 mg/kg
Children in a single urban pediatric emergency department (ED) randomized to receive IN midazolam at 0.4 mg/kg.
Intranasal midazolam: 5 mg/mL concentration of midazolam. Maximum dose = 10 mg. Administered using a mucosal atomization device.
|
0.5 mg/kg
Children in a single urban pediatric emergency department (ED) randomized to receive IN midazolam at 0.5 mg/kg.
Intranasal midazolam: 5 mg/mL concentration of midazolam. Maximum dose = 10 mg. Administered using a mucosal atomization device.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
19
|
24
|
29
|
29
|
|
Overall Study
COMPLETED
|
19
|
24
|
29
|
29
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dose-Finding Study of Intranasal Midazolam for Procedural Sedation in Children
Baseline characteristics by cohort
| Measure |
0.2 mg/kg
n=19 Participants
Children in a single urban pediatric emergency department (ED) randomized to receive IN midazolam at 0.2 mg/kg.
Intranasal midazolam: 5 mg/mL concentration of midazolam. Maximum dose = 10 mg. Administered using a mucosal atomization device.
|
0.3 mg/kg
n=24 Participants
Children in a single urban pediatric emergency department (ED) randomized to receive IN midazolam at 0.3 mg/kg.
Intranasal midazolam: 5 mg/mL concentration of midazolam. Maximum dose = 10 mg. Administered using a mucosal atomization device.
|
0.4 mg/kg
n=29 Participants
Children in a single urban pediatric emergency department (ED) randomized to receive IN midazolam at 0.4 mg/kg.
Intranasal midazolam: 5 mg/mL concentration of midazolam. Maximum dose = 10 mg. Administered using a mucosal atomization device.
|
0.5 mg/kg
n=29 Participants
Children in a single urban pediatric emergency department (ED) randomized to receive IN midazolam at 0.5 mg/kg.
Intranasal midazolam: 5 mg/mL concentration of midazolam. Maximum dose = 10 mg. Administered using a mucosal atomization device.
|
Total
n=101 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
19 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
29 Participants
n=27 Participants
|
29 Participants
n=483 Participants
|
101 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Age, Continuous
|
2 years
n=93 Participants
|
3 years
n=4 Participants
|
4 years
n=27 Participants
|
3 years
n=483 Participants
|
3 years
n=36 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
11 Participants
n=483 Participants
|
38 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
18 Participants
n=483 Participants
|
63 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
8 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
13 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
21 Participants
n=483 Participants
|
75 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
White
|
2 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
13 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=93 Participants
|
24 participants
n=4 Participants
|
29 participants
n=27 Participants
|
29 participants
n=483 Participants
|
101 participants
n=36 Participants
|
PRIMARY outcome
Timeframe: From study drug administration until procedure finished (approximately 60 minutes)The Pediatric Sedation State Scale (PSSS) is scored from 0 to 5, representing a continuum of sedation that spans from over-sedation associated with changes in vital signs (0) to inadequate sedation (5).
Outcome measures
| Measure |
0.2 mg/kg
n=19 Participants
Children in a single urban pediatric emergency department (ED) randomized to receive IN midazolam at 0.2 mg/kg.
Intranasal midazolam: 5 mg/mL concentration of midazolam. Maximum dose = 10 mg. Administered using a mucosal atomization device.
|
0.3 mg/kg
n=24 Participants
Children in a single urban pediatric emergency department (ED) randomized to receive IN midazolam at 0.3 mg/kg.
Intranasal midazolam: 5 mg/mL concentration of midazolam. Maximum dose = 10 mg. Administered using a mucosal atomization device.
|
0.4 mg/kg
n=29 Participants
Children in a single urban pediatric emergency department (ED) randomized to receive IN midazolam at 0.4 mg/kg.
Intranasal midazolam: 5 mg/mL concentration of midazolam. Maximum dose = 10 mg. Administered using a mucosal atomization device.
|
0.5 mg/kg
n=29 Participants
Children in a single urban pediatric emergency department (ED) randomized to receive IN midazolam at 0.5 mg/kg.
Intranasal midazolam: 5 mg/mL concentration of midazolam. Maximum dose = 10 mg. Administered using a mucosal atomization device.
|
|---|---|---|---|---|
|
Number of Children Who Achieved PSSS Score 2, 3, or 4 for 95% or Greater of the Scored Procedure
|
9 Participants
|
12 Participants
|
20 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: From study drug administration until patient discharge (approximately 120 minutes)Time (in minutes) from procedure completion until a Simplified Aldrete Score (SAS) of at least 6 is achieved. The score ranges from 0 (lowest) to 8 (highest). If a patient already fulfills criteria for recovery at procedure start, then time to recovery is 0.
Outcome measures
| Measure |
0.2 mg/kg
n=19 Participants
Children in a single urban pediatric emergency department (ED) randomized to receive IN midazolam at 0.2 mg/kg.
Intranasal midazolam: 5 mg/mL concentration of midazolam. Maximum dose = 10 mg. Administered using a mucosal atomization device.
|
0.3 mg/kg
n=24 Participants
Children in a single urban pediatric emergency department (ED) randomized to receive IN midazolam at 0.3 mg/kg.
Intranasal midazolam: 5 mg/mL concentration of midazolam. Maximum dose = 10 mg. Administered using a mucosal atomization device.
|
0.4 mg/kg
n=29 Participants
Children in a single urban pediatric emergency department (ED) randomized to receive IN midazolam at 0.4 mg/kg.
Intranasal midazolam: 5 mg/mL concentration of midazolam. Maximum dose = 10 mg. Administered using a mucosal atomization device.
|
0.5 mg/kg
n=29 Participants
Children in a single urban pediatric emergency department (ED) randomized to receive IN midazolam at 0.5 mg/kg.
Intranasal midazolam: 5 mg/mL concentration of midazolam. Maximum dose = 10 mg. Administered using a mucosal atomization device.
|
|---|---|---|---|---|
|
Time to Recovery
|
0 minutes
Interval 0.0 to 0.0
|
0 minutes
Interval 0.0 to 0.0
|
0 minutes
Interval 0.0 to 0.0
|
0 minutes
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: From study drug administration until patient discharge (approximately 120 minutes)Adverse events will be defined using the Pediatric Emergency Research Canada and Pediatric Emergency Care Applied Research Network Consensus-Based Recommendations. These adverse events include oxygen desaturation; apnea (central, obstructive, laryngospasm); clinically apparent pulmonary aspiration; retching/vomiting; bradycardia; hypotension; excitatory movements; paradoxical response to sedation; unpleasant recovery reactions; and permanent complications (including death).
Outcome measures
| Measure |
0.2 mg/kg
n=19 Participants
Children in a single urban pediatric emergency department (ED) randomized to receive IN midazolam at 0.2 mg/kg.
Intranasal midazolam: 5 mg/mL concentration of midazolam. Maximum dose = 10 mg. Administered using a mucosal atomization device.
|
0.3 mg/kg
n=24 Participants
Children in a single urban pediatric emergency department (ED) randomized to receive IN midazolam at 0.3 mg/kg.
Intranasal midazolam: 5 mg/mL concentration of midazolam. Maximum dose = 10 mg. Administered using a mucosal atomization device.
|
0.4 mg/kg
n=29 Participants
Children in a single urban pediatric emergency department (ED) randomized to receive IN midazolam at 0.4 mg/kg.
Intranasal midazolam: 5 mg/mL concentration of midazolam. Maximum dose = 10 mg. Administered using a mucosal atomization device.
|
0.5 mg/kg
n=29 Participants
Children in a single urban pediatric emergency department (ED) randomized to receive IN midazolam at 0.5 mg/kg.
Intranasal midazolam: 5 mg/mL concentration of midazolam. Maximum dose = 10 mg. Administered using a mucosal atomization device.
|
|---|---|---|---|---|
|
Number of Adverse Events
|
0 adverse events
|
0 adverse events
|
2 adverse events
|
0 adverse events
|
SECONDARY outcome
Timeframe: From study drug administration until procedure finished (approximately 60 minutes)Time (in minutes) from administration of intranasal midazolam until a University of Michigan Sedation State (UMSS) score of 1 is achieved. The UMSS represents a spectrum of depth of sedation ranging from unarousable (4) to awake and alert (0). Note: This outcome was initially listed as a primary outcome, but was changed to a secondary outcome in the IRB-approved protocol and prior to enrollment of the first patient.
Outcome measures
| Measure |
0.2 mg/kg
n=19 Participants
Children in a single urban pediatric emergency department (ED) randomized to receive IN midazolam at 0.2 mg/kg.
Intranasal midazolam: 5 mg/mL concentration of midazolam. Maximum dose = 10 mg. Administered using a mucosal atomization device.
|
0.3 mg/kg
n=24 Participants
Children in a single urban pediatric emergency department (ED) randomized to receive IN midazolam at 0.3 mg/kg.
Intranasal midazolam: 5 mg/mL concentration of midazolam. Maximum dose = 10 mg. Administered using a mucosal atomization device.
|
0.4 mg/kg
n=29 Participants
Children in a single urban pediatric emergency department (ED) randomized to receive IN midazolam at 0.4 mg/kg.
Intranasal midazolam: 5 mg/mL concentration of midazolam. Maximum dose = 10 mg. Administered using a mucosal atomization device.
|
0.5 mg/kg
n=29 Participants
Children in a single urban pediatric emergency department (ED) randomized to receive IN midazolam at 0.5 mg/kg.
Intranasal midazolam: 5 mg/mL concentration of midazolam. Maximum dose = 10 mg. Administered using a mucosal atomization device.
|
|---|---|---|---|---|
|
Time to Onset of Minimal Sedation
|
4.2 minutes
Interval 2.8 to 6.6
|
3.7 minutes
Interval 3.1 to 5.0
|
3.9 minutes
Interval 3.1 to 4.4
|
3.9 minutes
Interval 3.3 to 5.0
|
SECONDARY outcome
Timeframe: From study drug administration until procedure finished (approximately 60 minutes)Depth of sedation will be measured using the University of Michigan Sedation Scale (UMSS). This sedation scale ranges from zero to four with higher numbers indicating deeper sedation.
Outcome measures
| Measure |
0.2 mg/kg
n=19 Participants
Children in a single urban pediatric emergency department (ED) randomized to receive IN midazolam at 0.2 mg/kg.
Intranasal midazolam: 5 mg/mL concentration of midazolam. Maximum dose = 10 mg. Administered using a mucosal atomization device.
|
0.3 mg/kg
n=24 Participants
Children in a single urban pediatric emergency department (ED) randomized to receive IN midazolam at 0.3 mg/kg.
Intranasal midazolam: 5 mg/mL concentration of midazolam. Maximum dose = 10 mg. Administered using a mucosal atomization device.
|
0.4 mg/kg
n=29 Participants
Children in a single urban pediatric emergency department (ED) randomized to receive IN midazolam at 0.4 mg/kg.
Intranasal midazolam: 5 mg/mL concentration of midazolam. Maximum dose = 10 mg. Administered using a mucosal atomization device.
|
0.5 mg/kg
n=29 Participants
Children in a single urban pediatric emergency department (ED) randomized to receive IN midazolam at 0.5 mg/kg.
Intranasal midazolam: 5 mg/mL concentration of midazolam. Maximum dose = 10 mg. Administered using a mucosal atomization device.
|
|---|---|---|---|---|
|
UMSS Scale Score
UMSS = 0
|
3 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
|
UMSS Scale Score
UMSS = 1
|
16 Participants
|
22 Participants
|
28 Participants
|
27 Participants
|
|
UMSS Scale Score
UMSS = 2, 3 or 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
0.2 mg/kg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
0.3 mg/kg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
0.4 mg/kg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
0.5 mg/kg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
0.2 mg/kg
n=19 participants at risk
Children in a single urban pediatric emergency department (ED) randomized to receive IN midazolam at 0.2 mg/kg.
Intranasal midazolam: 5 mg/mL concentration of midazolam. Maximum dose = 10 mg. Administered using a mucosal atomization device.
|
0.3 mg/kg
n=24 participants at risk
Children in a single urban pediatric emergency department (ED) randomized to receive IN midazolam at 0.3 mg/kg.
Intranasal midazolam: 5 mg/mL concentration of midazolam. Maximum dose = 10 mg. Administered using a mucosal atomization device.
|
0.4 mg/kg
n=29 participants at risk
Children in a single urban pediatric emergency department (ED) randomized to receive IN midazolam at 0.4 mg/kg.
Intranasal midazolam: 5 mg/mL concentration of midazolam. Maximum dose = 10 mg. Administered using a mucosal atomization device.
|
0.5 mg/kg
n=29 participants at risk
Children in a single urban pediatric emergency department (ED) randomized to receive IN midazolam at 0.5 mg/kg.
Intranasal midazolam: 5 mg/mL concentration of midazolam. Maximum dose = 10 mg. Administered using a mucosal atomization device.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/19 • From time of intranasal midazolam administration until discharge from emergency department (approximately 120 minutes)
|
0.00%
0/24 • From time of intranasal midazolam administration until discharge from emergency department (approximately 120 minutes)
|
3.4%
1/29 • Number of events 1 • From time of intranasal midazolam administration until discharge from emergency department (approximately 120 minutes)
|
0.00%
0/29 • From time of intranasal midazolam administration until discharge from emergency department (approximately 120 minutes)
|
|
Nervous system disorders
Paradoxical reaction
|
0.00%
0/19 • From time of intranasal midazolam administration until discharge from emergency department (approximately 120 minutes)
|
0.00%
0/24 • From time of intranasal midazolam administration until discharge from emergency department (approximately 120 minutes)
|
3.4%
1/29 • Number of events 1 • From time of intranasal midazolam administration until discharge from emergency department (approximately 120 minutes)
|
0.00%
0/29 • From time of intranasal midazolam administration until discharge from emergency department (approximately 120 minutes)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place