Summary

Eligibility
for people ages 1 month to 16 years (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

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.

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

Keywords

MRI Sedation procedural sedation dexmedetomidine propofol MRI

Eligibility

You can join if…

Open to people ages 1 month to 16 years

  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

You CAN'T join if...

  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

  • University of California San Francisco not yet accepting patients
    San Francisco California 94143 United States
  • Lucile Packard Children's Hospital, Stanford not yet accepting patients
    Palo Alto California 94304 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Pfizer
Links
To obtain contact information for a study center near you, click here.
ID
NCT04237792
Phase
Phase 4
Study Type
Interventional
Last Updated