Trial Outcomes & Findings for Intranasal Midazolam in Children as a Pre-Operative Sedative (NCT NCT02314546)
NCT ID: NCT02314546
Last Updated: 2015-07-23
Results Overview
Measured by the administering RN. Measured as: agitated, alert, calm, drowsy, asleep.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
15 participants
Primary outcome timeframe
10 minutes post-sedation
Results posted on
2015-07-23
Participant Flow
Participant milestones
| Measure |
Saline Placebo
Control patients received intranasal saline.
|
Nasal Midazolam Only
Patients received 0.2 mg/kg of intranasal midazolam
|
Midazolam Plus Xylocaine
Patients received 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam.
|
|---|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
5
|
|
Overall Study
COMPLETED
|
5
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intranasal Midazolam in Children as a Pre-Operative Sedative
Baseline characteristics by cohort
| Measure |
Saline Placebo
n=5 Participants
Control patients received intranasal saline.
|
Nasal Midazolam Only
n=5 Participants
Patients received 0.2 mg/kg of intranasal midazolam
|
Midazolam Plus Xylocaine
n=5 Participants
Patients received 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
3.2 years
STANDARD_DEVIATION 2.2 • n=5 Participants
|
4.0 years
STANDARD_DEVIATION 1.2 • n=7 Participants
|
4.0 years
STANDARD_DEVIATION 2.0 • n=5 Participants
|
3.7 years
STANDARD_DEVIATION 1.8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
5 participants
n=5 Participants
|
15 participants
n=4 Participants
|
|
American Society of Anesthesiologists Physical Status Class
ASA Class 1
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
5 participants
n=4 Participants
|
|
American Society of Anesthesiologists Physical Status Class
ASA Class 2
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
10 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 10 minutes post-sedationPopulation: participants with available data at this time point
Measured by the administering RN. Measured as: agitated, alert, calm, drowsy, asleep.
Outcome measures
| Measure |
Saline Placebo
n=4 Participants
Control patients received intranasal saline.
|
Nasal Midazolam Only
n=4 Participants
Patients received 0.2 mg/kg of intranasal midazolam
|
Midazolam Plus Xylocaine
n=5 Participants
Patients received 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam.
|
|---|---|---|---|
|
Sedation Scale Score
Agitated
|
0 participants
|
0 participants
|
0 participants
|
|
Sedation Scale Score
Alert
|
1 participants
|
2 participants
|
2 participants
|
|
Sedation Scale Score
Calm
|
3 participants
|
2 participants
|
3 participants
|
|
Sedation Scale Score
Drowsy
|
0 participants
|
0 participants
|
0 participants
|
|
Sedation Scale Score
Asleep
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: 15 minutes post-sedationPopulation: participants with available data at this time point
Measured by the administering RN. Measured as: agitated, alert, calm, drowsy, asleep.
Outcome measures
| Measure |
Saline Placebo
n=4 Participants
Control patients received intranasal saline.
|
Nasal Midazolam Only
n=3 Participants
Patients received 0.2 mg/kg of intranasal midazolam
|
Midazolam Plus Xylocaine
n=3 Participants
Patients received 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam.
|
|---|---|---|---|
|
Sedation Scale Score
Agitated
|
0 participants
|
0 participants
|
0 participants
|
|
Sedation Scale Score
Alert
|
1 participants
|
1 participants
|
1 participants
|
|
Sedation Scale Score
Calm
|
3 participants
|
2 participants
|
2 participants
|
|
Sedation Scale Score
Drowsy
|
0 participants
|
0 participants
|
0 participants
|
|
Sedation Scale Score
Asleep
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Minutes from administration to dischargeOutcome measures
| Measure |
Saline Placebo
n=5 Participants
Control patients received intranasal saline.
|
Nasal Midazolam Only
n=5 Participants
Patients received 0.2 mg/kg of intranasal midazolam
|
Midazolam Plus Xylocaine
n=5 Participants
Patients received 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam.
|
|---|---|---|---|
|
Time From Administration to Discharge
|
87.0 minutes
Standard Deviation 21.9
|
74.2 minutes
Standard Deviation 9.6
|
97.0 minutes
Standard Deviation 18.9
|
SECONDARY outcome
Timeframe: 1 minute post-administrationMeasured by the accompanying parent using a Visual Analog Scale. The scale ranges from a minimum score of 0 (no distress at all) to a maximum of 10 (most distress possible).
Outcome measures
| Measure |
Saline Placebo
n=5 Participants
Control patients received intranasal saline.
|
Nasal Midazolam Only
n=5 Participants
Patients received 0.2 mg/kg of intranasal midazolam
|
Midazolam Plus Xylocaine
n=5 Participants
Patients received 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam.
|
|---|---|---|---|
|
Parental Observed Behavioral Distress Score
|
0.08 units on a scale
Standard Deviation 0.2
|
3.10 units on a scale
Standard Deviation 2.4
|
1.96 units on a scale
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: 1 minute post-administrationMeasured by the administering RN using a Visual Analog Scale. The scale ranges from a minimum score of 0 (no distress at all) to a maximum of 10 (most distress possible).
Outcome measures
| Measure |
Saline Placebo
n=5 Participants
Control patients received intranasal saline.
|
Nasal Midazolam Only
n=5 Participants
Patients received 0.2 mg/kg of intranasal midazolam
|
Midazolam Plus Xylocaine
n=5 Participants
Patients received 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam.
|
|---|---|---|---|
|
RN Observed Behavioral Distress Score
|
0.1 units on a scale
Standard Deviation 0.2
|
2.4 units on a scale
Standard Deviation 3.0
|
1.9 units on a scale
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: At time of administrationRecorded by the administering RN at the time of administration.
Outcome measures
| Measure |
Saline Placebo
n=5 Participants
Control patients received intranasal saline.
|
Nasal Midazolam Only
n=5 Participants
Patients received 0.2 mg/kg of intranasal midazolam
|
Midazolam Plus Xylocaine
n=5 Participants
Patients received 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam.
|
|---|---|---|---|
|
Verbal Complaint
No Complaint
|
3 participants
|
1 participants
|
2 participants
|
|
Verbal Complaint
Complaint Reported
|
2 participants
|
4 participants
|
3 participants
|
SECONDARY outcome
Timeframe: 1 minute post-administrationRecorded by the administering RN at one minute post-administration
Outcome measures
| Measure |
Saline Placebo
n=5 Participants
Control patients received intranasal saline.
|
Nasal Midazolam Only
n=5 Participants
Patients received 0.2 mg/kg of intranasal midazolam
|
Midazolam Plus Xylocaine
n=5 Participants
Patients received 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam.
|
|---|---|---|---|
|
Verbal Complaints
No Complaint
|
5 participants
|
3 participants
|
4 participants
|
|
Verbal Complaints
Complaint Reported
|
0 participants
|
2 participants
|
1 participants
|
Adverse Events
Saline Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Nasal Midazolam Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Midazolam Plus Xylocaine
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
David A. Ullman, MD, Senior Attending Anesthesiologist
Bassett Healthcare Network
Phone: 607-547-3153
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place