drugset / Trial / NCT03399838

Comparing in Dexmedetomidine With po/pr Midazolam for Procedural Sedation in the Pediatric Emergency Department

NCT03399838 ↗

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

EvaluationDrugModalityDoseRoute
Subject Dexmedetomidine Other / unclassified 4 ug/kg Intranasal
Comparator Midazolam Small molecule 0.5 mg Oral

Indications