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

PHASE4CompletedINTERVENTIONAL
Enrollment

128

Participants

Timeline

Start Date

February 18, 2020

Primary Completion Date

November 2, 2021

Study Completion Date

November 30, 2021

Conditions
MRI Sedation
Interventions
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

Trial Locations (23)

27710

Duke University Medical Center, Durham

27834

Brody School of Medicine at East Carolina University, Greenville

Vidant Medical Center, Greenville

30322

Children's Healthcare of Atlanta-Egleston, Atlanta

32207

Baptist Health - Wolfson Children's Hospital, Jacksonville

33407

St. Mary's Medical Center, West Palm Beach

44106

University Hospitals Rainbow Babies and Children's Hospital, Cleveland

46202

IU Health Riley Hospital for Children, Indianapolis

55454

M Health Fairview University of Minnesota Medical Center - West Bank, Minneapolis

72202

Arkansas Children's, Little Rock

73104

The Children's Hospital at OUMC, Oklahoma City

75235

Children's Medical Center, Dallas

77030

Texas Children's Hospital, Houston

94304

Lucile Packard Children's Hospital, Stanford, Palo Alto

95817

University of California Davis Medical Center, Sacramento

48109-4245

University of Michigan, C.S. Mott Children's Hospital, Ann Arbor

311-4145

Ibaraki Children Hospital, Mito

765-8507

Shikoku Medical Center for Children and Adults, Zentsujichó

594-1101

Osaka Women's and Children's Hospital, Izumi-shi

420 8660

Shizuoka Children's Hospital, Shizuoka

183-8561

Tokyo Metropolitan Children's Medical Center, Fuchū

157-8535

National Center for Child Health and Development, Setagaya-ku

534-0021

Osaka City General Hospital, Osaka

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY