CompletedPhase 4

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

United States128 participantsStarted 2020-02-18

Plain-language 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.

Who can participate

Age range1 Month – 16 Years

SexALL

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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

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 -

What they're measuring

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

Trial details

NCT IDNCT04237792

SponsorPfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-11-02

Results submitted2022-10-18

View on ClinicalTrials.gov More MRI Sedation trials