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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 Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
Conditions Laceration
Anxiety
Interventions Drug: Dexmedetomidine
Drug: Midazolam
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Dexmedetomidine Midazolam
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Intranasal Dexmedetomidine 2 micrograms/kilogram once

Dexmedetomidine: 20 patients enrolled, 20 underwent analysis

Intranasal Midazolam 0.4 milligram/kilogram

Midazolam: 20 patients enrolled, 18 underwent analysis

Period Title: Overall Study
Started 20 20
Completed 20 18
Not Completed 0 2
Reason Not Completed
Protocol Violation             0             2
Arm/Group Title Dexmedetomidine Midazolam Total
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Intranasal Dexmedetomidine 2 micrograms/kilogram once

Dexmedetomidine: .

Intranasal Midazolam 0.4 milligram/kilogram

Midazolam: .

Total of all reporting groups
Overall Number of Baseline Participants 20 18 38
Hide Baseline Analysis Population Description
38 patients were analyzed in total.
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 20 participants 18 participants 38 participants
3.44
(1.6 to 5.4)
3.15
(1.0 to 5.4)
3.21
(1.0 to 5.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 18 participants 38 participants
Female
7
  35.0%
6
  33.3%
13
  34.2%
Male
13
  65.0%
12
  66.7%
25
  65.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants 18 participants 38 participants
20 18 38
Laceration length  
Mean (Standard Deviation)
Unit of measure:  Centimeters
Number Analyzed 20 participants 18 participants 38 participants
1.59  (.87) 1.44  (.73) 1.52  (.79)
1.Primary Outcome
Title mYPAS Score as Completed by Researchers to Assess Anxiety
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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.

Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dexmedetomidine Midazolam
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Intranasal Dexmedetomidine 2 micrograms/kilogram once

Dexmedetomidine: 20 patients enrolled, 20 underwent analysis

Intranasal Midazolam 0.4 milligram/kilogram

Midazolam: 20 patients enrolled, 18 underwent analysis

Overall Number of Participants Analyzed 20 18
Median (95% Confidence Interval)
Unit of Measure: units on a scale
23.3
(23.3 to 30.8)
36.3
(32.5 to 38.8)
2.Secondary Outcome
Title mYPAS Scores at Other Time Points
Hide Description 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.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dexmedetomidine Midazolam
Hide Arm/Group Description:

Intranasal Dexmedetomidine 2 micrograms/kilogram once

Dexmedetomidine: 20 patients enrolled, 20 underwent analysis

Intranasal Midazolam 0.4 milligram/kilogram

Midazolam: 20 patients enrolled, 18 underwent analysis

Overall Number of Participants Analyzed 20 18
Median (95% Confidence Interval)
Unit of Measure: units on a scale
Baseline Anxiety
48.8
(36.7 to 82.5)
47.1
(40.0 to 51.3)
Anxiety at Wound Washout
42.5
(23.3 to 88.3)
47.1
(34.2 to 67.5)
Anxiety at First Stitch Placement
23.3
(23.3 to 89.2)
35.4
(31.3 to 52.9)
3.Secondary Outcome
Title VAS for Anxiety as Completed by Caregiver and Observer
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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.

Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dexmedetomidine Midazolam
Hide Arm/Group Description:

Intranasal Dexmedetomidine 2 micrograms/kilogram once

Dexmedetomidine: 20 patients enrolled, 20 underwent analysis

Intranasal Midazolam 0.4 milligram/kilogram

Midazolam: 20 patients enrolled, 18 underwent analysis

Overall Number of Participants Analyzed 20 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
VAS Baseline 3.8  (2.9) 3.5  (3.5)
VAS Position 1.7  (2.9) 1.6  (2.4)
VAS Recovery .7  (1.6) 1.2  (1.6)
4.Other Pre-specified Outcome
Title Procedure Completion
Hide Description note of whether the procedure was able to be completed
Time Frame Day 1
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dexmedetomidine Midazolam
Hide Arm/Group Description:

Intranasal Dexmedetomidine 2 micrograms/kilogram once

Dexmedetomidine: 20 patients enrolled, 20 underwent analysis

Intranasal Midazolam 0.4 milligram/kilogram

Midazolam: 20 patients enrolled, 18 underwent analysis

Overall Number of Participants Analyzed 20 18
Measure Type: Number
Unit of Measure: percentage of participants
100 100
5.Other Pre-specified Outcome
Title Need for Procedural Sedation
Hide Description Whether the patient required procedural sedation for completion of the procedure
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dexmedetomidine Midazolam
Hide Arm/Group Description:

Intranasal Dexmedetomidine 2 micrograms/kilogram once

Dexmedetomidine: 20 patients enrolled, 20 underwent analysis

Intranasal Midazolam 0.4 milligram/kilogram

Midazolam: 20 patients enrolled, 18 underwent analysis

Overall Number of Participants Analyzed 20 18
Measure Type: Number
Unit of Measure: percentage of participants
0 0
6.Other Pre-specified Outcome
Title Anxiolysis Satisfaction
Hide Description

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.

Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dexmedetomidine Midazolam
Hide Arm/Group Description:

Intranasal Dexmedetomidine 2 micrograms/kilogram once

Dexmedetomidine: 20 patients enrolled, 20 underwent analysis

Intranasal Midazolam 0.4 milligram/kilogram

Midazolam: 20 patients enrolled, 18 underwent analysis

Overall Number of Participants Analyzed 20 18
Median (Standard Deviation)
Unit of Measure: units on a scale
Parent Satisfaction 5  (1.3) 5  (1.1)
Proceduralist Satisfaction 4.5  (1.3) 5  (1.4)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dexmedetomidine Midazolam
Hide Arm/Group Description

Intranasal Dexmedetomidine 2 micrograms/kilogram once

Dexmedetomidine: 20 patients enrolled, 20 underwent analysis

Intranasal Midazolam 0.4 milligram/kilogram

Midazolam: 20 patients enrolled, 18 underwent analysis

All-Cause Mortality
Dexmedetomidine Midazolam
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Dexmedetomidine Midazolam
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/20 (0.00%)      0/18 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Dexmedetomidine Midazolam
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/20 (0.00%)      2/18 (11.11%)    
Gastrointestinal disorders     
vomiting * [1]  0/20 (0.00%)  0 1/18 (5.56%)  1
Nervous system disorders     
fall * 1 [2]  0/20 (0.00%)  0 1/18 (5.56%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, fall
[1]
vomiting after going home from repair
[2]
fall after repair while in the ED
2 patients not included in the midazolam group: one for equipment malfunction leading to no data collected and the second due to weight error resulting in the patient receiving over twice the dose. Both recognized around the time of enrollment.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Desiree Neville
Organization: Children's Hospital of Pittsburgh of UPMC
Phone: 4126927692
EMail: desiree.neville@chp.edu
Layout table for additonal information
Responsible Party: Desiree Neville, MD, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02168439    
Other Study ID Numbers: PRO13120431
UL1TR000005 ( U.S. NIH Grant/Contract )
First Submitted: June 16, 2014
First Posted: June 20, 2014
Results First Submitted: September 19, 2016
Results First Posted: March 10, 2017
Last Update Posted: March 10, 2017