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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

Tracking Information
First Submitted Date  ICMJE June 16, 2014
First Posted Date  ICMJE June 20, 2014
Results First Submitted Date  ICMJE September 19, 2016
Results First Posted Date  ICMJE March 10, 2017
Last Update Posted Date March 10, 2017
Study Start Date  ICMJE June 2014
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 20, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 17, 2014)
mYPAS Score as Completed by Researchers to Assess Anxiety [ Time Frame: Day 1 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 20, 2017)
  • 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 Measures  ICMJE
 (submitted: June 17, 2014)
VAS for Anxiety as Completed by Caregiver and Observer [ Time Frame: Day 1 ]
Current Other Pre-specified Outcome Measures
 (submitted: January 20, 2017)
  • Procedure Completion [ Time Frame: Day 1 ]
    note of whether the procedure was able to be completed
  • Need for Procedural Sedation [ Time Frame: Day 1 ]
    Whether the patient required procedural sedation for completion of the procedure
  • 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.
Original Other Pre-specified Outcome Measures
 (submitted: June 17, 2014)
  • Procedure Completion [ Time Frame: Day 1 ]
    note of whether the procedure was able to be completed
  • Need for Procedural Sedation [ Time Frame: Day 1 ]
    Whether the patient required procedural sedation for completion of the procedure
  • Anxiolysis Satisfaction [ Time Frame: Day 1 ]
    Likert scale parent, child life and proceduralist survey
 
Descriptive Information
Brief Title  ICMJE Intranasal Dexmedetomidine vs Intranasal Midazolam as Anxiolysis Prior to Pediatric Laceration Repair
Official Title  ICMJE Double Blinded Randomized Controlled Trial of Intranasal Dexmedetomidine Versus Intranasal Midazolam as Anxiolysis Prior to Pediatric Laceration Repair in the Emergency Department
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 Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Laceration
  • Anxiety
Intervention  ICMJE
  • Drug: Dexmedetomidine
    Other Name: Precedex
  • Drug: Midazolam
    Other Name: Versed
Study Arms  ICMJE
  • Experimental: Dexmedetomidine
    Intranasal Dexmedetomidine 2 micrograms/kilogram once
    Intervention: Drug: Dexmedetomidine
  • Experimental: Midazolam
    Intranasal Midazolam 0.4 milligram/kilogram
    Intervention: Drug: Midazolam
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 17, 2014)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2016
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 5 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02168439
Other Study ID Numbers  ICMJE PRO13120431
UL1TR000005 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Desiree Neville, MD, University of Pittsburgh
Study Sponsor  ICMJE University of Pittsburgh
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Desiree Neville, MD Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center
PRS Account University of Pittsburgh
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP