Clinical Trial: Intranasal Dexmedetomidine vs Intranasal Midazolam as Anxiolysis Prior to Pediatric Laceration Repair

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: University of Pittsburgh

Current Primary Outcome: mYPAS Score as Completed by Researchers to Assess Anxiety [ Time Frame: Day 1 ]

Original Primary Outcome: mYPAS Score as Completed by Researchers to Assess Anxiety [ Time Frame: Day 1 ]

Current Secondary Outcome:

• 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.

Original Secondary Outcome: VAS for Anxiety as Completed by Caregiver and Observer [ Time Frame: Day 1 ]

Information By: University of Pittsburgh

Dates:
Date Received: June 16, 2014
Date Started: June 2014
Date Completion:
Last Updated: January 20, 2017
Last Verified: January 2017