drugset / Trial / NCT03399838
Comparing in Dexmedetomidine With po/pr Midazolam for Procedural Sedation in the Pediatric Emergency Department
RandomizedParallel-groupTriple-blindTreatment
Summary
This study aims to compare efficacy of Procedural Sedation with Dexmedetomidine as compared to Midazolam in the pediatric Emergency Department. 210 children aged 6 months to 6 years will be included and randomly assigned to receiving oral or rectal midazolam (standard of care) or intranasal dexmedetomidine for procedures at the emergency department where mainly a sedation and no analgesia is sought. The procedure will be videotaped and analysis is blinded to the medication.
Timeline
- Start
- 2023-08
- Primary completion
- 2024-07-31
- Completion
- 2024-08-31
Outcome
Outcome not reported
Stopped: “Sponsor left the hospital”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dexmedetomidine | Other / unclassified | 4 ug/kg | Intranasal |
| Comparator | Midazolam | Small molecule | 0.5 mg | Oral |