Anxiety, Laceration
Conditions
Keywords
Dexmedetomidine, Midazolam
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.
Interventions
DRUGDexmedetomidine
DRUGMidazolam
Sponsors
University of Pittsburgh Clinical and Translational Science Institute (CTSI)
National Center for Advancing Translational Sciences (NCATS)
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Years to 5 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| mYPAS Score as Completed by Researchers to Assess Anxiety | 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
| Measure | Time frame | Description |
|---|---|---|
| mYPAS Scores at Other Time Points | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Procedure Completion | Day 1 | note of whether the procedure was able to be completed |
| Need for Procedural Sedation | Day 1 | Whether the patient required procedural sedation for completion of the procedure |
| Anxiolysis Satisfaction | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dexmedetomidine Intranasal Dexmedetomidine 2 micrograms/kilogram once
Dexmedetomidine: . | 20 |
| Midazolam Intranasal Midazolam 0.4 milligram/kilogram
Midazolam: . | 18 |
| Total | 38 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 0 | 2 |
Baseline characteristics
| Characteristic | Dexmedetomidine | Midazolam | Total |
|---|---|---|---|
| Age, Continuous | 3.44 years | 3.15 years | 3.21 years |
| Laceration length | 1.59 centimeters STANDARD_DEVIATION 0.87 | 1.44 centimeters STANDARD_DEVIATION 0.73 | 1.52 centimeters STANDARD_DEVIATION 0.79 |
| Region of Enrollment United States | 20 participants | 18 participants | 38 participants |
| Sex: Female, Male Female | 7 Participants | 6 Participants | 13 Participants |
| Sex: Female, Male Male | 13 Participants | 12 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 2 / 18 |
| serious Total, serious adverse events | 0 / 20 | 0 / 18 |
Outcome results
Primary
mYPAS Score as Completed by Researchers to Assess Anxiety
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Dexmedetomidine | mYPAS Score as Completed by Researchers to Assess Anxiety | 23.3 units on a scale |
| Midazolam | mYPAS Score as Completed by Researchers to Assess Anxiety | 36.3 units on a scale |
Secondary
mYPAS Scores at Other Time Points
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
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Dexmedetomidine | mYPAS Scores at Other Time Points | Baseline Anxiety | 48.8 units on a scale |
| Dexmedetomidine | mYPAS Scores at Other Time Points | Anxiety at Wound Washout | 42.5 units on a scale |
| Dexmedetomidine | mYPAS Scores at Other Time Points | Anxiety at First Stitch Placement | 23.3 units on a scale |
| Midazolam | mYPAS Scores at Other Time Points | Anxiety at First Stitch Placement | 35.4 units on a scale |
| Midazolam | mYPAS Scores at Other Time Points | Baseline Anxiety | 47.1 units on a scale |
| Midazolam | mYPAS Scores at Other Time Points | Anxiety at Wound Washout | 47.1 units on a scale |
Secondary
VAS for Anxiety as Completed by Caregiver and Observer
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dexmedetomidine | VAS for Anxiety as Completed by Caregiver and Observer | VAS Baseline | 3.8 units on a scale | Standard Deviation 2.9 |
| Dexmedetomidine | VAS for Anxiety as Completed by Caregiver and Observer | VAS Position | 1.7 units on a scale | Standard Deviation 2.9 |
| Dexmedetomidine | VAS for Anxiety as Completed by Caregiver and Observer | VAS Recovery | .7 units on a scale | Standard Deviation 1.6 |
| Midazolam | VAS for Anxiety as Completed by Caregiver and Observer | VAS Recovery | 1.2 units on a scale | Standard Deviation 1.6 |
| Midazolam | VAS for Anxiety as Completed by Caregiver and Observer | VAS Baseline | 3.5 units on a scale | Standard Deviation 3.5 |
| Midazolam | VAS for Anxiety as Completed by Caregiver and Observer | VAS Position | 1.6 units on a scale | Standard Deviation 2.4 |
Other Pre-specified
Anxiolysis Satisfaction
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
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Dexmedetomidine | Anxiolysis Satisfaction | Parent Satisfaction | 5 units on a scale | Standard Deviation 1.3 |
| Dexmedetomidine | Anxiolysis Satisfaction | Proceduralist Satisfaction | 4.5 units on a scale | Standard Deviation 1.3 |
| Midazolam | Anxiolysis Satisfaction | Parent Satisfaction | 5 units on a scale | Standard Deviation 1.1 |
| Midazolam | Anxiolysis Satisfaction | Proceduralist Satisfaction | 5 units on a scale | Standard Deviation 1.4 |
Other Pre-specified
Need for Procedural Sedation
Whether the patient required procedural sedation for completion of the procedure
Time frame: Day 1
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dexmedetomidine | Need for Procedural Sedation | 0 percentage of participants |
| Midazolam | Need for Procedural Sedation | 0 percentage of participants |
Other Pre-specified
Procedure Completion
note of whether the procedure was able to be completed
Time frame: Day 1
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dexmedetomidine | Procedure Completion | 100 percentage of participants |
| Midazolam | Procedure Completion | 100 percentage of participants |