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

• Sponsor: University of Pittsburgh (Other)
• Overall Status: Completed
• CT.gov ID: NCT02168439
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Duration (Months): 24
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

The objective of this research study is to show superiority of intranasal dexmedetomidine to intranasal midazolam as anxiolysis prior to pediatric laceration repairs.

Condition or Disease	Intervention/Treatment	Phase
Laceration; Anxiety	Drug: Dexmedetomidine; Drug: Midazolam	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Double Blinded Randomized Controlled Trial of Intranasal Dexmedetomidine Versus Intranasal Midazolam as Anxiolysis Prior to Pediatric Laceration Repair in the Emergency Department
• Study Start Date: Jun 1, 2014
• Actual Primary Completion Date: Apr 1, 2015
• Actual Study Completion Date: Jun 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dexmedetomidine Intranasal Dexmedetomidine 2 micrograms/kilogram once	Drug: Dexmedetomidine; Other Names: Precedex
Experimental: Midazolam Intranasal Midazolam 0.4 milligram/kilogram	Drug: Midazolam; Other Names: Versed

Outcome Measures

Primary Outcome Measures

1. mYPAS Score as Completed by Researchers to Assess Anxiety [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.

Secondary Outcome Measures

1. mYPAS Scores at Other Time Points [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.

2. VAS for Anxiety as Completed by Caregiver and Observer [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.

Other Outcome Measures

1. Procedure Completion [Day 1]

   note of whether the procedure was able to be completed

2. Need for Procedural Sedation [Day 1]

   Whether the patient required procedural sedation for completion of the procedure

3. Anxiolysis Satisfaction [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year to 5 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Presenting to Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center

• Laceration <5 cm in total length

• Require simple suture laceration repair

Exclusion Criteria:

• Allergies/intolerance/contraindication to the study drugs

• Lacerations requiring complex (multilayer) repair or total laceration length>5cm

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Hospital of Pittsburgh of UPMC	Pittsburgh	Pennsylvania	United States	15224

Sponsors and Collaborators

• University of Pittsburgh

Investigators

• Principal Investigator: Desiree Neville, MD, Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Desiree Neville, MD, M.D., Pediatric Emergency Medicine Fellow Physician, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT02168439
• Other Study ID Numbers: PRO13120431; UL1TR000005
• First Posted: Jun 20, 2014
• Last Update Posted: Mar 10, 2017
• Last Verified: Jan 1, 2017

• Keywords provided by Desiree Neville, MD, M.D., Pediatric Emergency Medicine Fellow Physician, University of Pittsburgh: Dexmedetomidine; Midazolam
• Additional relevant MeSH terms: Lacerations; Midazolam; Dexmedetomidine

Study Results

Participant Flow

Arm/Group Title	Dexmedetomidine	Midazolam
Arm/Group Description	Intranasal Dexmedetomidine 2 micrograms/kilogram once Dexmedetomidine: 20 patients enrolled, 20 underwent analysis	Intranasal Midazolam 0.4 milligram/kilogram Midazolam: 20 patients enrolled, 18 underwent analysis
Period Title: Overall Study
STARTED	20	20
COMPLETED	20	18
NOT COMPLETED	0	2

Baseline Characteristics

Arm/Group Title	Dexmedetomidine	Midazolam	Total
Arm/Group Description	Intranasal Dexmedetomidine 2 micrograms/kilogram once Dexmedetomidine: .	Intranasal Midazolam 0.4 milligram/kilogram Midazolam: .	Total of all reporting groups
Overall Participants	20	18	38
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	3.44	3.15	3.21
Sex: Female, Male (Count of Participants)
Female	7 35%	6 33.3%	13 34.2%
Male	13 65%	12 66.7%	25 65.8%
Region of Enrollment (participants) [Number]
United States	20 100%	18 100%	38 100%
Laceration length (centimeters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [centimeters]	1.59 (.87)	1.44 (.73)	1.52 (.79)

Outcome Measures

1. Primary Outcome

Title	mYPAS Score as Completed by Researchers to Assess Anxiety
Description	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.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexmedetomidine	Midazolam
Arm/Group Description	Intranasal Dexmedetomidine 2 micrograms/kilogram once Dexmedetomidine: 20 patients enrolled, 20 underwent analysis	Intranasal Midazolam 0.4 milligram/kilogram Midazolam: 20 patients enrolled, 18 underwent analysis
Measure Participants	20	18
Median (95% Confidence Interval) [units on a scale]	23.3	36.3

2. Secondary Outcome

Title	mYPAS Scores at Other Time Points
Description	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.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexmedetomidine	Midazolam
Arm/Group Description	Intranasal Dexmedetomidine 2 micrograms/kilogram once Dexmedetomidine: 20 patients enrolled, 20 underwent analysis	Intranasal Midazolam 0.4 milligram/kilogram Midazolam: 20 patients enrolled, 18 underwent analysis
Measure Participants	20	18
Baseline Anxiety	48.8	47.1
Anxiety at Wound Washout	42.5	47.1
Anxiety at First Stitch Placement	23.3	35.4

3. Secondary Outcome

Title	VAS for Anxiety as Completed by Caregiver and Observer
Description	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.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexmedetomidine	Midazolam
Arm/Group Description	Intranasal Dexmedetomidine 2 micrograms/kilogram once Dexmedetomidine: 20 patients enrolled, 20 underwent analysis	Intranasal Midazolam 0.4 milligram/kilogram Midazolam: 20 patients enrolled, 18 underwent analysis
Measure Participants	20	18
VAS Baseline	3.8 (2.9)	3.5 (3.5)
VAS Position	1.7 (2.9)	1.6 (2.4)
VAS Recovery	.7 (1.6)	1.2 (1.6)

4. Other Pre-specified Outcome

Title	Procedure Completion
Description	note of whether the procedure was able to be completed
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexmedetomidine	Midazolam
Arm/Group Description	Intranasal Dexmedetomidine 2 micrograms/kilogram once Dexmedetomidine: 20 patients enrolled, 20 underwent analysis	Intranasal Midazolam 0.4 milligram/kilogram Midazolam: 20 patients enrolled, 18 underwent analysis
Measure Participants	20	18
Number [percentage of participants]	100 500%	100 555.6%

5. Other Pre-specified Outcome

Title	Need for Procedural Sedation
Description	Whether the patient required procedural sedation for completion of the procedure
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexmedetomidine	Midazolam
Arm/Group Description	Intranasal Dexmedetomidine 2 micrograms/kilogram once Dexmedetomidine: 20 patients enrolled, 20 underwent analysis	Intranasal Midazolam 0.4 milligram/kilogram Midazolam: 20 patients enrolled, 18 underwent analysis
Measure Participants	20	18
Number [percentage of participants]	0 0%	0 0%

6. Other Pre-specified Outcome

Title	Anxiolysis Satisfaction
Description	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.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexmedetomidine	Midazolam
Arm/Group Description	Intranasal Dexmedetomidine 2 micrograms/kilogram once Dexmedetomidine: 20 patients enrolled, 20 underwent analysis	Intranasal Midazolam 0.4 milligram/kilogram Midazolam: 20 patients enrolled, 18 underwent analysis
Measure Participants	20	18
Parent Satisfaction	5 (1.3)	5 (1.1)
Proceduralist Satisfaction	4.5 (1.3)	5 (1.4)

Adverse Events

Arm/Group Title	Dexmedetomidine		Midazolam
Arm/Group Description	Intranasal Dexmedetomidine 2 micrograms/kilogram once Dexmedetomidine: 20 patients enrolled, 20 underwent analysis		Intranasal Midazolam 0.4 milligram/kilogram Midazolam: 20 patients enrolled, 18 underwent analysis
All Cause Mortality
	Dexmedetomidine		Midazolam
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Dexmedetomidine		Midazolam
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/18 (0%)
Other (Not Including Serious) Adverse Events
	Dexmedetomidine		Midazolam
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		2/18 (11.1%)
Gastrointestinal disorders
vomiting	0/20 (0%)	0	1/18 (5.6%)	1
Nervous system disorders
fall	0/20 (0%)	0	1/18 (5.6%)	1

Limitations/Caveats

2 patients not included in the midazolam group: one for equipment malfunction leading to no data collected and the second due to weight error resulting in the patient receiving over twice the dose. Both recognized around the time of enrollment.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.