Intranasal Dexmedetomidine vs Intranasal Midazolam as Anxiolysis Prior to Pediatric Laceration Repair
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ClinicalTrials.gov Identifier: NCT02168439 |
Recruitment Status :
Completed
First Posted : June 20, 2014
Results First Posted : March 10, 2017
Last Update Posted : March 10, 2017
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Sponsor:
University of Pittsburgh
Information provided by (Responsible Party):
Desiree Neville, MD, University of Pittsburgh
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Study Type | Interventional |
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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 |
Participant Flow
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 |
Baseline Characteristics
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 | |
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38 patients were analyzed in total.
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Age, Continuous
Mean (Full Range) Unit of measure: Years |
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Number Analyzed | 20 participants | 18 participants | 38 participants | |
3.44
(1.6 to 5.4)
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3.15
(1.0 to 5.4)
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3.21
(1.0 to 5.4)
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 20 participants | 18 participants | 38 participants | |
Female |
7 35.0%
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6 33.3%
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13 34.2%
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Male |
13 65.0%
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12 66.7%
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25 65.8%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 20 participants | 18 participants | 38 participants |
20 | 18 | 38 | ||
Laceration length
Mean (Standard Deviation) Unit of measure: Centimeters |
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Number Analyzed | 20 participants | 18 participants | 38 participants | |
1.59 (.87) | 1.44 (.73) | 1.52 (.79) |
Outcome Measures
Adverse Events
Limitations and Caveats
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.
More Information
Results Point of Contact
Name/Title: | Desiree Neville |
Organization: | Children's Hospital of Pittsburgh of UPMC |
Phone: | 4126927692 |
EMail: | desiree.neville@chp.edu |
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 |