Clinical trial NCT04237792: Safety and Efficacy of Dexmedetomidine (DEX) for Sedation of Subjects ≥1 Month to <17 Years Undergoing MRI Scans
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: MRI Sedation
Keywords: procedural sedation
dexmedetomidine
propofol
MRI
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2020-01-23
Enrollment: 128
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: Key Inclusion Criteria:

1. Male or female subject ≥1 month and \<17 years of age.
2. American Society of Anesthesiologists (ASA) Physical Status I, II or III.
3. 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.
4. Duration of the MRI scan is expected to take at least 20 minutes but no more than 3 hours to complete

Key Exclusion Criteria:

1. Pregnant female subjects (including those with an indeterminate or positive pregnancy test); breastfeeding female subjects.
2. 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.
3. Planned medical procedure during the MRI scan or post-MRI recovery period.
4. Requires endotracheal intubation or laryngeal mask airway (LMA).
5. Known allergy to eggs, egg products, soybeans or soybean products.
6. SpO2 \<93 % on room air -

Primary outcomes:
measure: 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
timeFrame: Up to maximum of 3 hours during MRI scan on Day 1
Secondary outcomes:
measure: Percentage of Participants at the DEX High Dose Versus Low Dose in Each Age Cohort Who Did Not Require Concomitant PRO to Complete MRI
timeFrame: Up to maximum of 3 hours during MRI scan on Day 1
measure: 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
timeFrame: Up to maximum of 3 hours during MRI scan on Day 1
measure: 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
timeFrame: Up to maximum of 3 hours during MRI scan on Day 1
measure: Time From the Start of DEX Loading Dose Infusion to the Time of First PRO Bolus Infusion - By Age Cohort and Combined Age
timeFrame: Up to maximum of 3 hours during MRI scan on Day 1
measure: Emergence Time - By Age Cohort and Combined Age
timeFrame: Post MRI scan on Day 1 up to 24 hours
measure: Number of Participants Who Received PRO - By Age Cohort and Combined Age
timeFrame: Up to maximum of 3 hours during MRI scan on Day 1
measure: Total Amount (mcg Per kg) of Concomitant PRO Required to Successfully Complete MRI - By Age Cohort and Combined Age
timeFrame: Up to maximum of 3 hours during MRI scan on Day 1
measure: Body Weight/Time Adjusted Total Amount (Per kg Per Minute) of Concomitant PRO Required to Successfully Complete MRI - By Age Cohort and Combined Age
timeFrame: Up to maximum of 3 hours during MRI scan on Day 1
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's
state: Arkansas
city: Palo Alto
country: United States
facility: Lucile Packard Children's Hospital, Stanford
state: California
city: Sacramento
country: United States
facility: University of California Davis Medical Center
state: California
city: Jacksonville
country: United States
facility: Baptist Health - Wolfson Children's Hospital
state: Florida
city: West Palm Beach
country: United States
facility: St. Mary's Medical Center
state: Florida
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta-Egleston
state: Georgia
city: Indianapolis
country: United States
facility: IU Health Riley Hospital for Children
state: Indiana
city: Ann Arbor
country: United States
facility: University of Michigan, C.S. Mott Children's Hospital
state: Michigan
city: Minneapolis
country: United States
facility: M Health Fairview University of Minnesota Medical Center - West Bank
state: Minnesota
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Greenville
country: United States
facility: Brody School of Medicine at East Carolina University
state: North Carolina
city: Greenville
country: United States
facility: Vidant Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Rainbow Babies and Children's Hospital
state: Ohio
city: Oklahoma City
country: United States
facility: The Children's Hospital at OUMC
state: Oklahoma
city: Dallas
country: United States
facility: Children's Medical Center
state: Texas
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
city: Mito
country: Japan
facility: Ibaraki Children Hospital
state: Ibaraki
city: Zentsuji
country: Japan
facility: Shikoku Medical Center for Children and Adults
state: Kagawa
city: Izumi-shi
country: Japan
facility: Osaka Women's and Children's Hospital
state: Osaka
city: Shizuoka-shi
country: Japan
facility: Shizuoka Children's Hospital
state: Shizuoka
city: Fuchu
country: Japan
facility: Tokyo Metropolitan Children's Medical Center
state: Tokyo
city: Setagaya-ku
country: Japan
facility: National Center for Child Health and Development
state: Tokyo
city: Osaka
country: Japan
facility: Osaka City General Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: