Oral Dexmedetomidine in Pediatric MRI

Part of paid clinical trials in Kansas City, Missouri.

Sponsor
Soroush Merchant
Study ID
NCT05619627
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Anesthesia

Eligibility Criteria

Sex
ALL
Age
3 Years - 6 Years
Healthy Volunteers
Accepted

Interventions

  • Dexmedetomidine — DRUG
    Participants will receive oral dexmedetomidine as the sole sedative agent for undergoing MRI
  • General Anesthesia (control group) — DRUG
    Participants will receive general anesthesia for their MRI

Study Details

The objective of this preliminary study is to assess the utility of oral dexmedetomidine as the sole sedative agent in pediatric population undergoing MRI.

Key Dates

Start date
Jun 1, 2026
Status verified
Apr 2026
Primary completion
Jun 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
18 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Dexmedetomidine 4 mcg/kg
    Group One: Subjects will receive oral dexmedetomidine 4 mcg/kg 2 hours prior to MRI
  • Experimental: Dexmedetomidine 6 mcg/kg
    Group Two: Subjects will receive oral dexmedetomidine 6 mcg/kg 2 hours prior to MRI
  • Experimental: Dexmedetomidine 8 mcg/kg
    Group Three: Subjects will receive oral dexmedetomidine 8 mcg/kg 2 hours prior to MRI
  • Experimental: Dexmedetomidine 10 mcg/kg
    Group Four: Subjects will receive oral dexmedetomidine 10 mcg/kg 2 hours prior to MRI
  • Experimental: Dexmedetomidine 12 mcg/kg
    Group Five: Subjects will receive oral dexmedetomidine 12 mcg/kg 2 hours prior to MRI
  • Active Comparator: General anesthesia
    Control group: Subjects will receive general anesthesia for their MRI

Primary Outcome Measure

Oral dexmedetomidine dose with adverse event below moderate risk, as designated by SIVA, to obtain adequate MRI study [ Time Frame: From date of the first enrollment until the end of assessment of data collected from the last participant, up to 70 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Children's Mercy HospitalKansas CityMissouri64108
Soroush Merchant, MD, MS
[email protected]
816-301-8595
Soroush Merchant, MD, MS (PRINCIPAL_INVESTIGATOR)
Kristin Leland, MD (SUB_INVESTIGATOR)

Find similar trials in Kansas City, MO

By research site
Children's Mercy Hospital· Kansas City, MO

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