Trials / Completed
CompletedNCT04237792
Safety and Efficacy of Dexmedetomidine (DEX) for Sedation of Subjects ≥1 Month to <17 Years Undergoing MRI Scans
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
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 128 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 1 Month – 16 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | dexmedetomidine | 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 |
| DRUG | propofol | propofol IV administration will be given if needed to maintain sedation |
Timeline
- Start date
- 2020-02-18
- Primary completion
- 2021-11-02
- Completion
- 2021-11-30
- First posted
- 2020-01-23
- Last updated
- 2022-11-16
- Results posted
- 2022-11-16
Locations
23 sites across 2 countries: United States, Japan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04237792. Inclusion in this directory is not an endorsement.