Intranasal Medications for Child Laceration Repair
IN Midazolam vs IN Dexmedetomidine vs IN Ketamine During Minimal Procedures in Pediatric ED
Recruiting
Phase 4
Interventional Study
Laceration of Skin
Anxiety
Discharge Time
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 1 – 5
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Supportive Care
- Participants needed
- 90 (estimated)
- Sponsor
- University of Oklahoma · Other
Who this trial is looking for
This trial is looking for children aged 1-5 who need stitches for small cuts. Participants will receive one of three medications through the nose to help them feel more comfortable during the procedure.
Are You a Good Fit for This Trial?
You may be able to join if
- I am between 1 and 5 years old
- I need suture repair for a cut less than or equal to 5cm
- My parent or caregiver speaks English
You may not be able to join if
- I am younger than 12 months or older than 5 years
- I need stitches for a cut greater than 5cm
- I have an allergy to Midazolam, Dexmedetomidine, Ketamine, or other sedatives
- I have abnormal vital signs for my age
- I have a history of heart, respiratory, kidney, or liver disease
- I have known electrolyte problems
- I have nasal or facial injury or deformity
- I have an abnormal neurological exam
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
About This Trial
Pain in young children has been universally under-recognized due to their inability to describe or localize pain. Improvements in pharmacological interventions are necessary to optimize patient and family experience and allow for successful and efficient procedure completion. This is the first study that will compare three intranasal medications (Intranasal Midazolam, Dexmedetomidine, and Ketamine…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Age 1-5 years old
* Presents to the ED for suture repair for lacerations less than or equal to 5cm in length
* Parent(s)/Caregiver(s) speak English
Exclusion Criteria:
* Younger than 12 months of age or older than 5 years old
* Suture repair needed for lacerations are greate…
Contacts