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New treatment option for Laceration of Skin
Official title Anxiolysis for Laceration Repair in Children
ClinicalTrials.gov ID: NCT05383495
What this study is testing
What is Dexmedetomidine?
Dexmedetomidine is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for laceration of skin.
Also referred to as Precedex.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a 3-arm adaptive clinical trial to the optimal light sedative for reducing distress during laceration repair in children. The investigators will compare intranasal (IN) dexmedetomidine, IN midazolam, and nitrous oxide (N20).
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 12
You may be able to join if
- i) Age 2-12.99 years [highest incidence of laceration repair] ii) Single or grouped lacerations separated by no more than 2 cm for which the treating...
You likely can't join if
- i) Sedative, anxiolytic, or alpha-2-adrenergic receptor agonist \< 24 hours prior to interventions (may compound sedative effect and increase the SAE...
- ii) Hypersensitivity to any intervention iii) Occlusion of \> 1 nostril due to polyps, septal deviation, or foreign body (may prevent drug...
The study team makes the final eligibility decision.
Where it's taking place
- London, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 12 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include London, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.