Comparing three medications for pain management in young children during minor procedures
Official title: Randomized Controlled Trial of Intranasal (IN) Midazolam vs IN Dexmedetomidine vs IN Ketamine Evaluating Length of Stay After Medication Administration and Anxiolysis During Minimal Procedures in Pediatric Population in Pediatric Emergency Department
Run by University of Oklahoma · NCT05934669 · Data updated 2026-11-12
This study is testing three different nasal medications to see which one helps young children feel less pain and anxiety during minor procedures in the emergency room.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 1 Year to 5 Years |
| Sex | All |
| Enrollment | 90 (estimated) |
| Sponsor | University of Oklahoma Academic / other |
| Locations | 1 site (Oklahoma City, Oklahoma) |
| Status | Recruiting |
| Started | November 14, 2023 |
| Main results expected | May 2025 |
| Study ends | June 2025 |
| Registry record updated | June 28, 2024 |
| Trial ID | NCT05934669 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children aged 1-5 years presenting to the emergency department for suture repair of lacerations less than or equal to 5cm.
✕Probably not a fit
Patients who are younger than 12 months or older than 5 years, or those with specific medical conditions or contraindications to the medications will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effectiveness of three intranasal medications—Midazolam, Dexmedetomidine, and Ketamine—in managing anxiety and pain during laceration repairs in pediatric patients aged 1-5 years. The goal is to determine which medication results in the shortest emergency department stay and highest satisfaction for both patients and providers. By comparing these medications, the study aims to improve the overall experience for children undergoing painful procedures in the emergency department. The research will also assess the pharmacokinetics and safety profiles of these medications in a pediatric setting.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for young children, enhancing their overall experience during emergency procedures.
How similar studies have gone: Previous studies have shown varying success with similar approaches, but this specific comparison of these three medications in a pediatric emergency setting is novel.
Who can join: the full rules
Show full inclusion / exclusion 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 greater than 5cm in length * Known allergy or adverse effect to Midazolam, Dexmedetomidine, Ketamine, or any other sedatives * Any abnormal vital signs for age, especially heart rate and blood pressure * History of Cardiac, respiratory, renal, or liver disease * Known electrolyte abnormalities * Any ocular trauma, nasal injury, nasal deformity, significant nasal congestion, abnormalities in the nasal or oral mucosa, facial deformity, or facial injury * Home medications include beta blockers or any other blood pressure lowering agents Classified American Society of Anesthesiologists III and above * Known or anticipated difficult airway * Abnormal neurological exam * Parent(s)/Caregiver(s) do not speak English
Where it's running
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University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States Recruiting
Study contacts
- Principal investigator: Ryan Mckee, MD — University of Oklahoma
- Study coordinator: Gavely Toor, DO
- Email: gavely-toor@ouhsc.edu
- Phone: 405-271-2429
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.