Safety and Efficacy of Dexmedetomidine (DEX) for Sedation of Subjects ≥1 Month to <17 Years Undergoing MRI Scans
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 4 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: dexmedetomidine low dose group low dose of dexmedetomidine to be given |
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
|
Experimental: dexmedetomidine middle dose group middle dose of dexmedetomidine to be given |
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
|
Experimental: dexmedetomidine high dose group high dose of dexmedetomidine to be given |
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
|
Outcome Measures
Primary Outcome Measures
- Percent of subjects at the DEX high dose level versus the low dose level in the combined age cohorts who do not require concomitant PRO to complete the MRI [baseline up to 3 hours]
Secondary Outcome Measures
- Percent of subjects at the DEX high dose level versus the low dose level in each age cohort who do not require concomitant PRO to complete the MRI [baseline up to 3 hours]
- Percent of subjects at the DEX middle dose level compared to the high dose level and the low dose level in both the overall sample and in each age cohort who do not require concomitant PRO to complete the MRI [baseline up to 3 hours]
- Percent of time at the target sedation rating scale score (Pediatric Sedation State Scale [PSSS] rating of 2) after the administration of the DEX loading dose and during the DEX maintenance infusion [baseline up to 3 hours]
- The amount of time from the start of the DEX loading dose infusion to the time of the first PRO bolus administration [baseline up to 3 hours]
- Emergence time (defined as the time from the end of the MRI scan to when the subject meets a Modified Aldrete Score ≥9) [post-procedure up to 24 hours]
- The proportion of subjects at each DEX dose level who receive PRO [baseline up to 3 hours]
- Total amount (mg/kg) and weight and time adjusted amount (per kg per minute basis) of concomitant PRO required to successfully complete the MRI scan [baseline up to 3 hours]
Eligibility Criteria
Criteria
Key Inclusion Criteria:
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Male or female subject ≥1 month and <17 years of age.
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American Society of Anesthesiologists (ASA) Physical Status I, II or III.
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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.
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Duration of the MRI scan is expected to take at least 20 minutes but no more than 3 hours to complete
Key Exclusion Criteria:
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Pregnant female subjects (including those with an indeterminate or positive pregnancy test); breastfeeding female subjects.
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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.
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Planned medical procedure during the MRI scan or post-MRI recovery period.
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Requires endotracheal intubation or laryngeal mask airway (LMA).
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Known allergy to eggs, egg products, soybeans or soybean products.
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SpO2 <93 % on room air -
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Arkansas Children's | Little Rock | Arkansas | United States | 72202 |
2 | Lucile Packard Children's Hospital, Stanford | Palo Alto | California | United States | 94304 |
3 | University of California Davis Medical Center | Sacramento | California | United States | 95817 |
4 | Baptist Health - Wolfson Children's Hospital | Jacksonville | Florida | United States | 32207 |
5 | St. Mary's Medical Center | West Palm Beach | Florida | United States | 33407 |
6 | Children's Healthcare of Atlanta-Egleston | Atlanta | Georgia | United States | 30322 |
7 | IU Health Riley Hospital for Children | Indianapolis | Indiana | United States | 46202 |
8 | University of Michigan, C.S. Mott Children's Hospital | Ann Arbor | Michigan | United States | 48109-4245 |
9 | M Health Fairview University of Minnesota Medical Center - West Bank | Minneapolis | Minnesota | United States | 55454 |
10 | Duke University Medical Center | Durham | North Carolina | United States | 27710 |
11 | Brody School of Medicine at East Carolina University | Greenville | North Carolina | United States | 27834 |
12 | Vidant Medical Center | Greenville | North Carolina | United States | 27834 |
13 | University Hospitals Rainbow Babies and Children's Hospital | Cleveland | Ohio | United States | 44106 |
14 | The Children's Hospital at OUMC | Oklahoma City | Oklahoma | United States | 73104 |
15 | Children's Medical Center | Dallas | Texas | United States | 75235 |
16 | Texas Children's Hospital | Houston | Texas | United States | 77030 |
17 | Ibaraki Children Hospital | Mito | Ibaraki | Japan | 311-4145 |
18 | Shikoku Medical Center for Children and Adults | Zentsuji | Kagawa | Japan | 765-8507 |
19 | Osaka Women's and Children's Hospital | Izumi-shi | Osaka | Japan | 594-1101 |
20 | Shizuoka Children's Hospital | Shizuoka-shi | Shizuoka | Japan | 420 8660 |
21 | Tokyo Metropolitan Children's Medical Center | Fuchu | Tokyo | Japan | 183-8561 |
22 | National Center for Child Health and Development | Setagaya-ku | Tokyo | Japan | 157-8535 |
23 | Osaka City General Hospital | Osaka | Japan | 534-0021 |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- C0801039