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
1 other identifier
interventional
128
2 countries
23
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Feb 2020
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 17, 2020
CompletedFirst Posted
Study publicly available on registry
January 23, 2020
CompletedStudy Start
First participant enrolled
February 18, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 2, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2021
CompletedResults Posted
Study results publicly available
November 16, 2022
CompletedNovember 16, 2022
October 1, 2022
1.7 years
January 17, 2020
October 18, 2022
October 18, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants at the DEX High Dose Versus Low Dose in the Combined Age Cohorts Who Did Not Require Concomitant PRO to Complete MRI
Percentage of participants who did not require PRO to complete MRI scan in the combined age cohorts are reported in this outcome measure.
Up to maximum of 3 hours during MRI scan on Day 1
Secondary Outcomes (8)
Percentage of Participants at the DEX High Dose Versus Low Dose in Each Age Cohort Who Did Not Require Concomitant PRO to Complete MRI
Up to maximum of 3 hours during MRI scan on Day 1
Percentage of Participants at the DEX Middle Dose vs Low Dose and High Dose vs Middle Dose in Each Age Cohort and Combined Age Cohorts Who Did Not Require Concomitant PRO to Complete MRI
Up to maximum of 3 hours during MRI scan on Day 1
Percentage of Time at Target Pediatric Sedation State Scale (PSSS) Score of 2 After the Administration of the DEX Loading Dose and During the DEX Maintenance Infusion - By Age Cohort and Combined Age
Up to maximum of 3 hours during MRI scan on Day 1
Time From the Start of DEX Loading Dose Infusion to the Time of First PRO Bolus Infusion - By Age Cohort and Combined Age
Up to maximum of 3 hours during MRI scan on Day 1
Emergence Time - By Age Cohort and Combined Age
Post MRI scan on Day 1 up to 24 hours
- +3 more secondary outcomes
Study Arms (3)
dexmedetomidine low dose group
EXPERIMENTALlow dose of dexmedetomidine to be given
dexmedetomidine middle dose group
EXPERIMENTALmiddle dose of dexmedetomidine to be given
dexmedetomidine high dose group
EXPERIMENTALhigh dose of dexmedetomidine to be given
Interventions
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
propofol IV administration will be given if needed to maintain sedation
Eligibility Criteria
You may qualify if:
- Male or female subject ≥1 month and \<17 years of age.
- American Society of Anesthesiologists (ASA) Physical Status I, II or III.
- Requires non-intubated, spontaneous breathing, moderate to deep sedation (NI MDS) for a magnetic resonance imaging (MRI) study with an intensivist, anesthesiologist or other proceduralist in attendance.
- Duration of the MRI scan is expected to take at least 20 minutes but no more than 3 hours to complete
You may not qualify if:
- Pregnant female subjects (including those with an indeterminate or positive pregnancy test); breastfeeding female subjects.
- Weight on Day 1 before randomization is less than the 10th percentile of weight for age and sex in the US and Japan or is greater than the 95th percentile of weight for age and sex in the US or greater than the 97th percentile of weight for age and sex in Japan based on sponsor-provided growth charts.
- Planned medical procedure during the MRI scan or post-MRI recovery period.
- Requires endotracheal intubation or laryngeal mask airway (LMA).
- Known allergy to eggs, egg products, soybeans or soybean products.
- SpO2 \<93 % on room air -
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (23)
Arkansas Children's
Little Rock, Arkansas, 72202, United States
Lucile Packard Children's Hospital, Stanford
Palo Alto, California, 94304, United States
University of California Davis Medical Center
Sacramento, California, 95817, United States
Baptist Health - Wolfson Children's Hospital
Jacksonville, Florida, 32207, United States
St. Mary's Medical Center
West Palm Beach, Florida, 33407, United States
Children's Healthcare of Atlanta-Egleston
Atlanta, Georgia, 30322, United States
IU Health Riley Hospital for Children
Indianapolis, Indiana, 46202, United States
University of Michigan, C.S. Mott Children's Hospital
Ann Arbor, Michigan, 48109-4245, United States
M Health Fairview University of Minnesota Medical Center - West Bank
Minneapolis, Minnesota, 55454, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Brody School of Medicine at East Carolina University
Greenville, North Carolina, 27834, United States
Vidant Medical Center
Greenville, North Carolina, 27834, United States
University Hospitals Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106, United States
The Children's Hospital at OUMC
Oklahoma City, Oklahoma, 73104, United States
Children's Medical Center
Dallas, Texas, 75235, United States
Texas Children's Hospital
Houston, Texas, 77030, United States
Ibaraki Children Hospital
Mito, Ibaraki, 311-4145, Japan
Shikoku Medical Center for Children and Adults
Zentsujichó, Kagawa-ken, 765-8507, Japan
Osaka Women's and Children's Hospital
Izumi-shi, Osaka, 594-1101, Japan
Shizuoka Children's Hospital
Shizuoka, Shizuoka, 420 8660, Japan
Tokyo Metropolitan Children's Medical Center
Fuchū, Tokyo, 183-8561, Japan
National Center for Child Health and Development
Setagaya-ku, Tokyo, 157-8535, Japan
Osaka City General Hospital
Osaka, 534-0021, Japan
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 17, 2020
First Posted
January 23, 2020
Study Start
February 18, 2020
Primary Completion
November 2, 2021
Study Completion
November 30, 2021
Last Updated
November 16, 2022
Results First Posted
November 16, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.