Phase 4
N=128
Safety and Efficacy of Dexmedetomidine (DEX) for Sedation of Subjects ≥1 Month to <17 Years Undergoing MRI Scans
MRI Sedation
Bottom Line
View on ClinicalTrials.gov: NCT04237792 ↗Enrolled (actual)
128
Serious AEs
0.8%
Results posted
Nov 2022
Primary outcome: Primary: 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 — 63.2; 14.3 Percentage of participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- dexmedetomidine (Drug); propofol (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Nov 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
63.2; 14.3 | <0.001 sig |
| SECONDARY Percentage of Participants at the DEX High Dose Versus Low Dose in Each Age Cohort Who Did Not Require Concomitant PRO to Complete MRI |
50.0; 15.0; 75.0; 13.6 | 0.022 sig |
| SECONDARY 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 |
50.0; 9.5; 15.0; 75.0; 61.9; 13.6 | 0.006 sig |
| SECONDARY 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 |
77.5; 82.5; 87.8; 76.8; 92.2; 94.1 | 0.021 sig |
| SECONDARY Time From the Start of DEX Loading Dose Infusion to the Time of First PRO Bolus Infusion - By Age Cohort and Combined Age |
16.0; 17.0; 62.0; 16.5; NA; NA | 0.016 sig |
| SECONDARY Emergence Time - By Age Cohort and Combined Age |
30.0; 41.0; 38.0; 35.0; 46.0; 50.0 | 0.884 |
| SECONDARY Number of Participants Who Received PRO - By Age Cohort and Combined Age |
17; 19; 9; 19; 8; 5 | — |
| SECONDARY Total Amount (mcg Per kg) of Concomitant PRO Required to Successfully Complete MRI - By Age Cohort and Combined Age |
4012.1; 4730.3; 2822.8; 5559.2; 5001.9; 4513.0 | 0.124 |
| SECONDARY Body Weight/Time Adjusted Total Amount (Per kg Per Minute) of Concomitant PRO Required to Successfully Complete MRI - By Age Cohort and Combined Age |
59.43; 71.38; 47.41; 81.28; 74.70; 76.36 | 0.048 sig |
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
- 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
Key Exclusion Criteria
- 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 -
Data sourced from ClinicalTrials.gov (NCT04237792). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.