Intranasal Dexmedetomidine vs Intranasal Midazolam as Anxiolysis Prior to Pediatric Laceration Repair
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|ClinicalTrials.gov Identifier: NCT02168439|
Recruitment Status : Completed
First Posted : June 20, 2014
Results First Posted : March 10, 2017
Last Update Posted : March 10, 2017
|Condition or disease||Intervention/treatment||Phase|
|Laceration Anxiety||Drug: Dexmedetomidine Drug: Midazolam||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|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 :||June 2014|
|Actual Primary Completion Date :||April 2015|
|Actual Study Completion Date :||June 2016|
Intranasal Dexmedetomidine 2 micrograms/kilogram once
Other Name: Precedex
Intranasal Midazolam 0.4 milligram/kilogram
Other Name: Versed
- mYPAS Score as Completed by Researchers to Assess Anxiety [ Time Frame: 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.
- mYPAS Scores at Other Time Points [ Time Frame: 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.
- VAS for Anxiety as Completed by Caregiver and Observer [ Time Frame: 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.
- Procedure Completion [ Time Frame: Day 1 ]note of whether the procedure was able to be completed
- Need for Procedural Sedation [ Time Frame: Day 1 ]Whether the patient required procedural sedation for completion of the procedure
- Anxiolysis Satisfaction [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02168439
|United States, Pennsylvania|
|Children's Hospital of Pittsburgh of UPMC|
|Pittsburgh, Pennsylvania, United States, 15224|
|Principal Investigator:||Desiree Neville, MD||Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center|