Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| UL1TR000005 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Pittsburgh Clinical and Translational Science Institute (CTSI) | UNKNOWN |
| National Center for Advancing Translational Sciences (NCATS) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of this research study is to show superiority of intranasal dexmedetomidine to intranasal midazolam as anxiolysis prior to pediatric laceration repairs.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine | Experimental | Intranasal Dexmedetomidine 2 micrograms/kilogram once |
|
| Midazolam | Experimental | Intranasal Midazolam 0.4 milligram/kilogram |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug |
|
| |
| Midazolam |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 |
| VAS for Anxiety as Completed by Caregiver and Observer |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure Completion | note of whether the procedure was able to be completed | Day 1 |
| Need for Procedural Sedation | Whether the patient required procedural sedation for completion of the procedure |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Desiree Neville, MD | Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania | 15224 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Dexmedetomidine | Intranasal Dexmedetomidine 2 micrograms/kilogram once Dexmedetomidine: 20 patients enrolled, 20 underwent analysis |
| FG001 | Midazolam | Intranasal Midazolam 0.4 milligram/kilogram Midazolam: 20 patients enrolled, 18 underwent analysis |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
38 patients were analyzed in total.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Dexmedetomidine | Intranasal Dexmedetomidine 2 micrograms/kilogram once Dexmedetomidine: . |
| BG001 | Midazolam | Intranasal Midazolam 0.4 milligram/kilogram Midazolam: . |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Median | 95% Confidence Interval | units on a scale | Day 1 |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dexmedetomidine | Intranasal Dexmedetomidine 2 micrograms/kilogram once Dexmedetomidine: 20 patients enrolled, 20 underwent analysis |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| vomiting | Gastrointestinal disorders | Non-systematic Assessment | vomiting after going home from repair |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Desiree Neville | Children's Hospital of Pittsburgh of UPMC | 4126927692 | desiree.neville@chp.edu |
Not provided
| ID | Term |
|---|---|
| D022125 | Lacerations |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
|
|
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. |
| Day 1 |
| Day 1 |
| 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. | Day 1 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Laceration length | Mean | Standard Deviation | centimeters |
|
|
|
| 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. | Posted | Median | 95% Confidence Interval | units on a scale | Day 1 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Day 1 |
|
|
|
| Other Pre-specified | Procedure Completion | note of whether the procedure was able to be completed | Posted | Number | percentage of participants | Day 1 |
|
|
|
| Other Pre-specified | Need for Procedural Sedation | Whether the patient required procedural sedation for completion of the procedure | Posted | Number | percentage of participants | Day 1 |
|
|
|
| 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. | Posted | Median | Standard Deviation | units on a scale | Day 1 |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Midazolam | Intranasal Midazolam 0.4 milligram/kilogram Midazolam: 20 patients enrolled, 18 underwent analysis | 0 | 18 | 2 | 18 |
|
| fall | Nervous system disorders | fall | Non-systematic Assessment | fall after repair while in the ED |
|
Not provided
Not provided
| D001569 |
| Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| Anxiety at First Stitch Placement |
|
| VAS Recovery |
|