Back to resultsIntranasal Dexmedetomidine vs Intranasal Midazolam as Anxiolysis Prior to Pediatric Laceration Repair
Primary Purpose
Laceration, Anxiety
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Dexmedetomidine
Midazolam
Sponsored by
About this trial
This is an interventional supportive care trial for Laceration focused on measuring Dexmedetomidine, Midazolam
Eligibility Criteria
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
Sites / Locations
- Children's Hospital of Pittsburgh of UPMC
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Dexmedetomidine
Midazolam
Arm Description
Intranasal Dexmedetomidine 2 micrograms/kilogram once
Intranasal Midazolam 0.4 milligram/kilogram
Outcomes
Primary Outcome Measures
mYPAS Score as Completed by Researchers to Assess Anxiety
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
mYPAS Scores at Other Time Points
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.
VAS for Anxiety as Completed by Caregiver and Observer
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.
Full Information
NCT ID
NCT02168439
First Posted
June 16, 2014
Last Updated
January 20, 2017
Sponsor
University of Pittsburgh
1. Study Identification
Unique Protocol Identification Number
NCT02168439
Brief Title
Intranasal Dexmedetomidine vs Intranasal Midazolam as Anxiolysis Prior to Pediatric Laceration Repair
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 Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laceration, Anxiety
Keywords
Dexmedetomidine, Midazolam
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dexmedetomidine
Arm Type
Experimental
Arm Description
Intranasal Dexmedetomidine 2 micrograms/kilogram once
Arm Title
Midazolam
Arm Type
Experimental
Arm Description
Intranasal Midazolam 0.4 milligram/kilogram
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Precedex
Intervention Type
Drug
Intervention Name(s)
Midazolam
Other Intervention Name(s)
Versed
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
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
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
Other Pre-specified Outcome Measures:
Title
Procedure Completion
Description
note of whether the procedure was able to be completed
Time Frame
Day 1
Title
Need for Procedural Sedation
Description
Whether the patient required procedural sedation for completion of the procedure
Time Frame
Day 1
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Desiree Neville, MD
Organizational Affiliation
Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Pittsburgh of UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
12. IPD Sharing Statement
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Intranasal Dexmedetomidine vs Intranasal Midazolam as Anxiolysis Prior to Pediatric Laceration Repair
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