LacerationPhase 4NCT02168439
Intranasal Dexmedetomidine vs Intranasal Midazolam as Anxiolysis Prior to Pediatric Laceration Repair
A Phase 4 study testing Dexmedetomidine and Midazolam in people with Laceration and Anxiety, run by University of Pittsburgh at 1 site in United States.
Trial summary
The objective of this research study is to show superiority of intranasal dexmedetomidine to intranasal midazolam as anxiolysis prior to pediatric laceration repairs. Read more about this study
- Who is it for?
- Ages 1 year to 5 years
- Conditions the study is for
- Laceration, Anxiety
- What is being tested?
- Dexmedetomidine and Midazolam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Jun 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Presenting to Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center
- Laceration <5 cm in total length
- Require simple suture laceration repair
Who cannot join
- Allergies/intolerance/contraindication to the study drugs
- Lacerations requiring complex (multilayer) repair or total laceration length>5cm
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
About this study
Official title: Double Blinded Randomized Controlled Trial of Intranasal Dexmedetomidine Versus Intranasal Midazolam as Anxiolysis Prior to Pediatric Laceration Repair in the Emergency Department
The objective of this research study is to show superiority of intranasal dexmedetomidine to intranasal midazolam as anxiolysis prior to pediatric laceration repairs.
- Conditions
- Laceration, Anxiety
- Being tested
- Dexmedetomidine, Midazolam
- Keywords
- Dexmedetomidine, Midazolam
- Medical subject headings
- Lacerations, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Precedex
MidazolamDrug
Also called Versed
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Experimental | Intranasal Dexmedetomidine 2 micrograms/kilogram once Receives: Drug: Dexmedetomidine |
| Midazolam | Experimental | Intranasal Midazolam 0.4 milligram/kilogram Receives: Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (2)
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.
Measured: 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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionApr 2015
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for LacerationStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pittsburgh Clinical and Translational Science Institute (CTSI), National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Principal investigator, Desiree Neville, MD, University of Pittsburgh
- Investigators
- Desiree Neville, MD, Principal investigator, Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02168439
- Sponsor's protocol ID
- PRO13120431
- Other IDs
- UL1TR000005
- Status last verified
- Nov 2024
- First submitted
- 16 Jun 2014
- Last updated
- 14 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blinded Randomized Controlled Trial of Intranasal Dexmedetomidine Versus Intranasal Midazolam as Anxiolysis Prior to Pediatric Laceration Repair in the Emergency Department
- ClinicalTrials.gov ID
- NCT02168439
- Acronym / sponsor ID
- PRO13120431
- Conditions
- Laceration, Anxiety
- Keywords
- Dexmedetomidine, Midazolam
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- University of Pittsburgh Clinical and Translational Science Institute (CTSI), National Center for Advancing Translational Sciences (NCATS)
- Study start
- Jun 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 20 Jun 2014 (estimated)
- Results
- Posted 10 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this research study is to show superiority of intranasal dexmedetomidine to intranasal midazolam as anxiolysis prior to pediatric laceration repairs.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Experimental | Drug: DexmedetomidineIntranasal Dexmedetomidine 2 micrograms/kilogram once |
| Midazolam | Experimental | Drug: MidazolamIntranasal Midazolam 0.4 milligram/kilogram |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Presenting to Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center
- Laceration <5 cm in total length
- Require simple suture laceration repair
Key exclusion criteria (2 listed)
- Allergies/intolerance/contraindication to the study drugs
- Lacerations requiring complex (multilayer) repair or total laceration length>5cm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidineAlso: Precedex | Drug | Dexmedetomidine |
| MidazolamAlso: Versed | Drug | Midazolam |
Primary outcome
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.
2 secondary outcomes
mYPAS Scores at Other Time Points
Time frame: Day 1
VAS for Anxiety as Completed by Caregiver and Observer
Time frame: Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Desiree Neville, MD principal investigator
Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine and Midazolam in people with Laceration and Anxiety, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mYPAS Score as Completed by Researchers to Assess Anxiety (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2024.