A Phase 4 interventional study of Dexmedetomidine and Midazolam in Laceration and Anxiety, sponsored by University of Pittsburgh. Completed at 1 site in United States. Open to participants aged 1 Year to 5 Years. Per ClinicalTrials.gov, last updated 2024-11-14.
Sponsored by University of Pittsburgh · Phase 4, Interventional, and Supportive care
Among 60 studies in Lacerations with a site in United States — 12 open to participants now, 14 under way, 1 of them phase 3. Lacerations · United States.
Among the 60 studies in Lacerations with a site in United States, this one is the 32nd largest by enrollment of the 52 interventional ones, is one of 5 that started in 2014, is one of 10 in phase 4, and was the 21st registered.
174 studies on the registry are indexed under Lacerations; 43 are open to participants now.
This study's enrollment of 40 is below the median of 65 across 128 interventional studies indexed under Lacerations.
Browse Lacerations studies →12 of the 60 studies in Lacerations with a site in United States are open now, in 1 country. Each count lists the studies.
Of the 27 Lacerations studies recruiting now, 15 (56%) set no upper age limit and 10 (37%) stop at 75 or younger; 6 take children under 18; 9 take healthy volunteers.
This study: 1 Year to 5 Years · all sexes · no healthy volunteers.
The full table on the hub →60 studies; the count open now beside each. This study's row is marked.
First in 2000; this study’s year is marked. 5 started in 2014.
Median enrollment 52 across the 52 interventional studies, 50 across the 7 observational. Of the 36 that completed or were terminated, 18 (50%) have results posted.
8 of 60 have an industry lead sponsor. The 10 most frequent:
University of Pittsburgh is the lead sponsor of 1,419 studies on the registry; 168 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.
University of Pittsburgh has 1 study filed under Lacerations — fewer than ten, so there is no comparison to draw.
6 of the studies in Lacerations with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06910241Phase 3Florida Atlantic UniversityLidocaine Versus Diphenhydramine to Achieve Local Anesthesia for Laceration Repairs | 2027-06-30 |
| NCT07606625University of California, BerkeleyOcular Surface Health and Tear Film Stability With a Nasal Spray Dry Eye Treatment | 2026-12-31 |
| NCT07068880Brett LewellynClinical Analysis of a Novel Flexor Tendon Repair Technique | 2027-01 |
| NCT07632183Edward Via Virginia College of Osteopathic MedicineWill a Hands on Technique Applied to the Face Increase the Tear Production in Participants | 2027-06 |
| NCT07688967Arthroresearch LLCMeasuring Knee Laxity and Pivot Shift in ACL-Deficient Patients | 2027-07 |
Among the 60 studies in Lacerations with a site in United States, from their registry updates:
The objective of this research study is to show superiority of intranasal dexmedetomidine to intranasal midazolam as anxiolysis prior to pediatric laceration repairs.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intranasal Dexmedetomidine 2 micrograms/kilogram once
Drug: Dexmedetomidine
Intranasal Midazolam 0.4 milligram/kilogram
Drug: Midazolam
Also known as: Precedex
Also known as: Versed
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
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
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
Procedure Completion
note of whether the procedure was able to be completed
Time frame: Day 1
Need for Procedural Sedation
Whether the patient required procedural sedation for completion of the procedure
Time frame: 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.
Time frame: Day 1
| Milestone | Dexmedetomidine | Midazolam |
|---|---|---|
| Started | 20 | 20 |
| Completed | 20 | 18 |
| Not completed | 0 | 2 |
| Withdrew: Protocol violation | 0 | 2 |
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.
| units on a scale | Dexmedetomidine | Midazolam |
|---|---|---|
| mYPAS Score as Completed by Researchers to Assess Anxiety | 23.3 (23.3 to 30.8) | 36.3 (32.5 to 38.8) |
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.
| units on a scale | Dexmedetomidine | Midazolam |
|---|---|---|
| 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) |
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.
| units on a scale | Dexmedetomidine | Midazolam |
|---|---|---|
| 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 |
note of whether the procedure was able to be completed
| percentage of participants | Dexmedetomidine | Midazolam |
|---|---|---|
| Procedure Completion | 100 | 100 |
Whether the patient required procedural sedation for completion of the procedure
| percentage of participants | Dexmedetomidine | Midazolam |
|---|---|---|
| Need for Procedural Sedation | 0 | 0 |
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.
| units on a scale | Dexmedetomidine | Midazolam |
|---|---|---|
| Parent Satisfaction | 5 ± 1.3 | 5 ± 1.1 |
| Proceduralist Satisfaction | 4.5 ± 1.3 | 5 ± 1.4 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dexmedetomidine | — | 0/20 (0%) | 0/20 (0%) |
| Midazolam | — | 0/18 (0%) | 2/18 (11.1%) |
| Event | Dexmedetomidine | Midazolam |
|---|---|---|
| vomitingGastrointestinal disorders | 0/20 | 1/18 |
| fallNervous system disorders | 0/20 | 1/18 |
38 patients were analyzed in total.
| Age, Continuous(years) | Dexmedetomidine | Midazolam | Total |
|---|---|---|---|
| Mean | 3.44 (1.6 to 5.4) | 3.15 (1.0 to 5.4) | 3.21 (1.0 to 5.4) |
| Sex: Female, Male(Participants) | Dexmedetomidine | Midazolam | Total |
|---|---|---|---|
| Female | 7 | 6 | 13 |
| Male | 13 | 12 | 25 |
| Region of Enrollment(participants) | Dexmedetomidine | Midazolam | Total |
|---|---|---|---|
| United States | 20 | 18 | 38 |
| Laceration length(centimeters) | Dexmedetomidine | Midazolam | Total |
|---|---|---|---|
| Mean | 1.59 ± .87 | 1.44 ± .73 | 1.52 ± .79 |
The record gives a start of Jun 2014, a primary completion of Apr 2015 and a completion of Jun 2016. It does not say whether these dates are actual or estimated.
Results were first posted in Mar 2017, 1 year 11 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Dexmedetomidine · Midazolam