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

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

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

Study Overview

• Status: Completed
• Conditions: Anxiety; Laceration
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Midazolam

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15224
      • Children's Hospital of Pittsburgh of UPMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure Completion	note of whether the procedure was able to be completed	Day 1
Need for Procedural Sedation	Whether the patient required procedural sedation for completion of the procedure	Day 1
Anxiolysis Satisfaction	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.	Day 1

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: June 16, 2014
• First Submitted That Met QC Criteria: June 17, 2014
• First Posted (Estimate): June 20, 2014

Study Record Updates

• Last Update Posted (Actual): March 10, 2017
• Last Update Submitted That Met QC Criteria: January 20, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Dexmedetomidine; Midazolam
• Additional Relevant MeSH Terms: Wounds and Injuries; Lacerations; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Midazolam; Dexmedetomidine
• Other Study ID Numbers: PRO13120431; UL1TR000005 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No