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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02168439
Recruitment Status : Completed
First Posted : June 20, 2014
Results First Posted : March 10, 2017
Last Update Posted : March 10, 2017
Sponsor:
Information provided by (Responsible Party):
Desiree Neville, MD, University of Pittsburgh

Study Description
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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.

Condition or disease Intervention/treatment Phase
Laceration Anxiety Drug: Dexmedetomidine Drug: Midazolam Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Tears

Arms and Interventions
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Arm Intervention/treatment
Experimental: Dexmedetomidine
Intranasal Dexmedetomidine 2 micrograms/kilogram once
 Drug: Dexmedetomidine
Other Name: Precedex
Experimental: Midazolam
Intranasal Midazolam 0.4 milligram/kilogram
 Drug: Midazolam
Other Name: Versed


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



Eligibility Criteria
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Ages Eligible for Study:   1 Year to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, Pennsylvania
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15224
Sponsors and Collaborators
University of Pittsburgh
Investigators
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Principal Investigator: Desiree Neville, MD Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center
More Information
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Responsible Party: Desiree Neville, MD, M.D., Pediatric Emergency Medicine Fellow Physician, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02168439    
Other Study ID Numbers: PRO13120431
UL1TR000005 ( U.S. NIH Grant/Contract )
First Posted: June 20, 2014    Key Record Dates
Results First Posted: March 10, 2017
Last Update Posted: March 10, 2017
Last Verified: January 2017
Keywords provided by Desiree Neville, MD, University of Pittsburgh:
Dexmedetomidine
Midazolam
Additional relevant MeSH terms:
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Lacerations
Wounds and Injuries
Midazolam
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
 Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents