Oral Dexmedetomidine for Pediatric Anesthesia

Overseen By Kelsye Howell, MSN, RN

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Children's Mercy Hospital Kansas City

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

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

Research Team

Soroush Merchant, MD, MS

Principal Investigator

Children's Mercy Hospital Kansas City

Eligibility Criteria

This trial is for children aged 4 months to 6 years who need anesthesia for an MRI. They must not be using digoxin, have craniofacial anomalies, recent apnea, or severe medical conditions that make sedation risky. Kids with allergies to dexmedetomidine or certain heart and respiratory diseases can't participate.

Inclusion Criteria

I am between 4 months and 6 years old.

I am scheduled for an MRI with anesthesia for medical reasons.

Exclusion Criteria

I have recently had a stroke.

Known allergy to dexmedetomidine

I refuse to take oral dexmedetomidine.

Treatment Details

Interventions

• Dexmedetomidine (Alpha-2 Agonist)
• General Anesthetic (General Anesthetic)

Trial Overview The study is testing if oral dexmedetomidine alone can safely sedate kids during an MRI. It's a preliminary test to see if this method works without needing other general anesthetics.

Participant Groups

Group I: Dexmedetomidine 8 mcg/kg Experimental Treatment 1 Intervention

Group Three: Subjects will receive oral dexmedetomidine 8 mcg/kg 2 hours prior to MRI

Group II: Dexmedetomidine 6 mcg/kg Experimental Treatment 1 Intervention

Group Two: Subjects will receive oral dexmedetomidine 6 mcg/kg 2 hours prior to MRI

Group III: Dexmedetomidine 4 mcg/kg Experimental Treatment 1 Intervention

Group One: Subjects will receive oral dexmedetomidine 4 mcg/kg 2 hours prior to MRI

Group IV: Dexmedetomidine 12 mcg/kg Experimental Treatment 1 Intervention

Group Five: Subjects will receive oral dexmedetomidine 12 mcg/kg 2 hours prior to MRI

Group V: Dexmedetomidine 10 mcg/kg Experimental Treatment 1 Intervention

Group Four: Subjects will receive oral dexmedetomidine 10 mcg/kg 2 hours prior to MRI

Group VI: General anesthesia Active Control 1 Intervention

Control group: Subjects will receive general anesthesia for their MRI

Dexmedetomidine is already approved in Canada, Japan for the following indications:

Approved in Canada as Precedex for:

• Sedation in intensive care settings
• Procedural sedation

Approved in Japan as Precedex for:

• Sedation in intensive care settings
• Procedural sedation

Who Is Running the Clinical Trial?

Children's Mercy Hospital Kansas City

Lead Sponsor

Trials

261

Recruited

941,000+