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

Study Overview
=================
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.

Official Title
-----------------
Double Blinded Randomized Controlled Trial of Intranasal Dexmedetomidine Versus Intranasal Midazolam as Anxiolysis Prior to Pediatric Laceration Repair in the Emergency Department

Conditions
-----------------
Laceration, Anxiety

Intervention / Treatment
-----------------
* Drug: Dexmedetomidine
* Drug: Midazolam


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 5 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexmedetomidine<br>Intranasal Dexmedetomidine 2 micrograms/kilogram once | Drug: Dexmedetomidine<br> <br> * Other names: Precedex;|
| Experimental: Midazolam<br>Intranasal Midazolam 0.4 milligram/kilogram | Drug: Midazolam<br> <br> * Other names: Versed;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 1 | 
| 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. | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dexmedetomidine, Midazolam