CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 128 enrolled
Drug / intervention
dexmedetomidine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04237792
NCT04237792Phase 4Completed
CompareCT.gov

A PHASE 3/4 RANDOMIZED, DOUBLE-BLIND, DOSE-RANGING STUDY OF THE SAFETY AND EFFICACY OF DEXMEDETOMIDINE (DEX) USED WITH PROPOFOL (PRO) AS NEEDED FOR PROCEDURAL SEDATION OF PEDIATRIC SUBJECTS ≥1 MONTH TO <17 YEARS OF AGE UNDERGOING MRI SCANS

Pfizer·interventional·Posted Jan 23, 2020·Updated Nov 16, 2022

In Brief

A Phase 4 clinical trial evaluating dexmedetomidine and propofol for MRI Sedation. Completed, enrolled 128 participants across 23 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMRI Sedation
CountriesJapan, United States
Collaborators--

Timeline

Phase 4CompletedFinished
2020202120222023202420252026
First PostedJan 23, 2020
Enrollment StartFeb 18, 2020
Primary CompletionNov 2, 2021
Study CompletionNov 30, 2021
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 6.4 years ago

Interventions

dexmedetomidinedrug

dexmedetomidine low, middle and high doses are provided as an intravenous bolus loading dose followed by an intravenous maintenance dose infusion throughout the MRI scan

propofoldrug

propofol IV administration will be given if needed to maintain sedation