drugset / Trial / NCT05057689
Safety & Efficacy of Intranasal Dexmedetomidine, Fentanyl & Midazolam in the Pediatric Emergency Room
RandomizedParallel-groupTriple-blindTreatment
Summary
The hypothesis is that intranasal dexmedetomidine will provide significantly more effective analgesia and anxiolysis for subjects undergoing a simple laceration repair when compared to either intranasal fentanyl or intranasal midazolam. Additional hypotheses include that there will be 1) no significant increase in adverse effects between drugs and 2) significantly higher satisfaction rates for both subject experience and ease of laceration repair based on structured, proceduralist feedback.
Timeline
- Start
- 2025-09
- Primary completion
- 2025-10
- Completion
- 2025-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dexmedetomidine | Other / unclassified | 4 ug/kg | Intranasal |
| Subject | Fentanyl | Other / unclassified | 2 ug/kg | Intranasal |
| Subject | Midazolam | Small molecule | 0.3 mg/kg | Intranasal |