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
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Laceration Anxiety | Drug: Dexmedetomidine Drug: Midazolam | Phase 4 |
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 |

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 |
- 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.
- 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.
- 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 1 Year to 5 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
United States, Pennsylvania | |
Children's Hospital of Pittsburgh of UPMC | |
Pittsburgh, Pennsylvania, United States, 15224 |
Principal Investigator: | Desiree Neville, MD | Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center |
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 |
Dexmedetomidine Midazolam |
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 |