Safety and Efficacy of Dexmedetomidine (DEX) for Sedation of Subjects ≥1 Month to <17 Years Undergoing MRI Scans

Summary

This is a randomized, double-blind, dose-ranging study of the efficacy and safety of dexmedetomidine (DEX) when used with propofol as needed, for procedural sedation of pediatric subjects ≥1 month to \<17 years of age undergoing MRI scans in the US and Japan.

Timeline

Start

2020-02-18

Primary completion

2021-11-02

Completion

2021-11-30

Outcome

Met primary endpoint

registry NUMBER High Dose: Combined Age: 63.2 (46.0 to 78.0) Percentage of participants NCT04237792 ↗

registry analysis (other test); High Dose: Combined Age vs Low Dose: Combined Age; p <0.001; Odds Ratio (OR) 0.10 (95% CI 0.03 to 0.29); Cochran-Mantel-Haenszel NCT04237792 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dexmedetomidine	Other / unclassified	—	Intravenous
Background	Propofol	Small molecule	—	Intravenous

Indications

No indication recorded.