Trial Outcomes & Findings for Intranasal Dexmedetomidine vs Intranasal Midazolam as Anxiolysis Prior to Pediatric Laceration Repair (NCT NCT02168439)

Results Overview

Primary outcome was the mYPAS scores at the time of positioning for procedure. mYPAS stands for modified Yale Preoperative anxiety scale. The scale is from minimum 23.3- maximum 100. Higher scores indicate higher anxiety. By prior characterization, scores less than or equal to 30 are classified as not anxious.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

40 participants

Primary outcome timeframe

Day 1

Results posted on

2024-11-14

Participant Flow

Participant milestones

Participant milestones
Measure	Dexmedetomidine Intranasal Dexmedetomidine 2 micrograms/kilogram once Dexmedetomidine: 20 patients enrolled, 20 underwent analysis	Midazolam Intranasal Midazolam 0.4 milligram/kilogram Midazolam: 20 patients enrolled, 18 underwent analysis
Overall Study STARTED	20	20
Overall Study COMPLETED	20	18
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Dexmedetomidine Intranasal Dexmedetomidine 2 micrograms/kilogram once Dexmedetomidine: 20 patients enrolled, 20 underwent analysis	Midazolam Intranasal Midazolam 0.4 milligram/kilogram Midazolam: 20 patients enrolled, 18 underwent analysis
Overall Study Protocol Violation	0	2

Baseline Characteristics

Intranasal Dexmedetomidine vs Intranasal Midazolam as Anxiolysis Prior to Pediatric Laceration Repair

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dexmedetomidine n=20 Participants Intranasal Dexmedetomidine 2 micrograms/kilogram once Dexmedetomidine: .	Midazolam n=18 Participants Intranasal Midazolam 0.4 milligram/kilogram Midazolam: .	Total n=38 Participants Total of all reporting groups
Age, Continuous	3.44 years n=5 Participants	3.15 years n=7 Participants	3.21 years n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	12 Participants n=7 Participants	25 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants	18 participants n=7 Participants	38 participants n=5 Participants
Laceration length	1.59 centimeters STANDARD_DEVIATION .87 • n=5 Participants	1.44 centimeters STANDARD_DEVIATION .73 • n=7 Participants	1.52 centimeters STANDARD_DEVIATION .79 • n=5 Participants

PRIMARY outcome

Timeframe: Day 1

Primary outcome was the mYPAS scores at the time of positioning for procedure. mYPAS stands for modified Yale Preoperative anxiety scale. The scale is from minimum 23.3- maximum 100. Higher scores indicate higher anxiety. By prior characterization, scores less than or equal to 30 are classified as not anxious.

Outcome measures

Outcome measures
Measure	Dexmedetomidine n=20 Participants Intranasal Dexmedetomidine 2 micrograms/kilogram once Dexmedetomidine: 20 patients enrolled, 20 underwent analysis	Midazolam n=18 Participants Intranasal Midazolam 0.4 milligram/kilogram Midazolam: 20 patients enrolled, 18 underwent analysis
mYPAS Score as Completed by Researchers to Assess Anxiety	23.3 units on a scale Interval 23.3 to 30.8	36.3 units on a scale Interval 32.5 to 38.8

SECONDARY outcome

Timeframe: Day 1

mYPAS stands for modified Yale Preoperative anxiety scale. The scale is from minimum 23.3- maximum 100. Higher scores indicate higher anxiety. By prior characterization, scores less than or equal to 30 are classified as not anxious.

Outcome measures

Outcome measures
Measure	Dexmedetomidine n=20 Participants Intranasal Dexmedetomidine 2 micrograms/kilogram once Dexmedetomidine: 20 patients enrolled, 20 underwent analysis	Midazolam n=18 Participants Intranasal Midazolam 0.4 milligram/kilogram Midazolam: 20 patients enrolled, 18 underwent analysis
mYPAS Scores at Other Time Points Baseline Anxiety	48.8 units on a scale Interval 36.7 to 82.5	47.1 units on a scale Interval 40.0 to 51.3
mYPAS Scores at Other Time Points Anxiety at Wound Washout	42.5 units on a scale Interval 23.3 to 88.3	47.1 units on a scale Interval 34.2 to 67.5
mYPAS Scores at Other Time Points Anxiety at First Stitch Placement	23.3 units on a scale Interval 23.3 to 89.2	35.4 units on a scale Interval 31.3 to 52.9

SECONDARY outcome

Timeframe: Day 1

VAS, Visual Analog Scale for anxiety. Scale from 0-10 written on a 10 cm horizontal line with the extremes labeled as no anxiety to very anxious. Vertical line is drawn on the scale at the level of anxiety. The distance was measured. Higher numbers equal higher anxiety.

Outcome measures

Outcome measures
Measure	Dexmedetomidine n=20 Participants Intranasal Dexmedetomidine 2 micrograms/kilogram once Dexmedetomidine: 20 patients enrolled, 20 underwent analysis	Midazolam n=18 Participants Intranasal Midazolam 0.4 milligram/kilogram Midazolam: 20 patients enrolled, 18 underwent analysis
VAS for Anxiety as Completed by Caregiver and Observer VAS Baseline	3.8 units on a scale Standard Deviation 2.9	3.5 units on a scale Standard Deviation 3.5
VAS for Anxiety as Completed by Caregiver and Observer VAS Position	1.7 units on a scale Standard Deviation 2.9	1.6 units on a scale Standard Deviation 2.4
VAS for Anxiety as Completed by Caregiver and Observer VAS Recovery	.7 units on a scale Standard Deviation 1.6	1.2 units on a scale Standard Deviation 1.6

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 1

note of whether the procedure was able to be completed

Outcome measures

Outcome measures
Measure	Dexmedetomidine n=20 Participants Intranasal Dexmedetomidine 2 micrograms/kilogram once Dexmedetomidine: 20 patients enrolled, 20 underwent analysis	Midazolam n=18 Participants Intranasal Midazolam 0.4 milligram/kilogram Midazolam: 20 patients enrolled, 18 underwent analysis
Procedure Completion	100 percentage of participants	100 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 1

Whether the patient required procedural sedation for completion of the procedure

Outcome measures

Outcome measures
Measure	Dexmedetomidine n=20 Participants Intranasal Dexmedetomidine 2 micrograms/kilogram once Dexmedetomidine: 20 patients enrolled, 20 underwent analysis	Midazolam n=18 Participants Intranasal Midazolam 0.4 milligram/kilogram Midazolam: 20 patients enrolled, 18 underwent analysis
Need for Procedural Sedation	0 percentage of participants	0 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 1

Likert scale parent, child life and proceduralist survey 5 point likert scale asking how satisfied the parent or proceduralist is with the anxiolysis from the medication. 1 being not satisfied at all, 3 neutral, 5 very satisfied.

Outcome measures

Outcome measures
Measure	Dexmedetomidine n=20 Participants Intranasal Dexmedetomidine 2 micrograms/kilogram once Dexmedetomidine: 20 patients enrolled, 20 underwent analysis	Midazolam n=18 Participants Intranasal Midazolam 0.4 milligram/kilogram Midazolam: 20 patients enrolled, 18 underwent analysis
Anxiolysis Satisfaction Parent Satisfaction	5 units on a scale Standard Deviation 1.3	5 units on a scale Standard Deviation 1.1
Anxiolysis Satisfaction Proceduralist Satisfaction	4.5 units on a scale Standard Deviation 1.3	5 units on a scale Standard Deviation 1.4

Adverse Events

Dexmedetomidine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Midazolam

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Dexmedetomidine n=20 participants at risk Intranasal Dexmedetomidine 2 micrograms/kilogram once Dexmedetomidine: 20 patients enrolled, 20 underwent analysis	Midazolam n=18 participants at risk Intranasal Midazolam 0.4 milligram/kilogram Midazolam: 20 patients enrolled, 18 underwent analysis
Gastrointestinal disorders vomiting	0.00% 0/20	5.6% 1/18 • Number of events 1
Nervous system disorders fall	0.00% 0/20	5.6% 1/18 • Number of events 1

Additional Information

Desiree Neville

Children's Hospital of Pittsburgh of UPMC

Phone: 4126927692

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place