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Completed

NCT Number: NCT02168439

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

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

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Key information

Conditions

Laceration Anxiety Anxiety Disorders Lacerations Mental Disorders Wounds and Injuries

Age range

1 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15224, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

Drug

Other names: Precedex

midazolam

Drug

Other names: Versed

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Other outcomes

  1. Procedure Completion

    Time frame: Day 1

    note of whether the procedure was able to be completed

  2. Need for Procedural Sedation

    Time frame: Day 1

    Whether the patient required procedural sedation for completion of the procedure

  3. 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.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)
  • University of Pittsburgh Clinical and Translational Science Institute (CTSI)

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Jun 20, 2014
Registry last updated
Nov 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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