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

CompletedPhase 4

Sponsor: Pfizer

Conditions: MRI Sedation

Interventions: dexmedetomidine, propofol

Countries: United States, Japan

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 overview

Sex: ALL

Age: 1 Month to 16 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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 -

Locations (23)

Little Rock, Arkansas, United States
Palo Alto, California, United States
Sacramento, California, United States
Jacksonville, Florida, United States
West Palm Beach, Florida, United States
Atlanta, Georgia, United States
Indianapolis, Indiana, United States
Ann Arbor, Michigan, United States
Minneapolis, Minnesota, United States
Durham, North Carolina, United States
Greenville, North Carolina, United States
Greenville, North Carolina, United States
Cleveland, Ohio, United States
Oklahoma City, Oklahoma, United States
Dallas, Texas, United States
Houston, Texas, United States
Mito, Ibaraki, Japan
Zentsujichó, Kagawa-ken, Japan
Izumi-shi, Osaka, Japan
Shizuoka, Shizuoka, Japan
Fuchū, Tokyo, Japan
Setagaya-ku, Tokyo, Japan
Osaka, Japan