Oral Dexmedetomidine in Pediatric MRI

• Status: Not yet recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Children's Mercy Hospital Kansas City
• Treatments: Anesthetics; Anesthetics, General; Dexmedetomidine

Criteria

Inclusion Criteria:

1. Subjects ages 4 months to 6 years

2. Undergoing a clinically indicated MRI with anesthesia

Exclusion Criteria:

1. Refusal to take oral dexmedetomidine

2. Inability to take dexmedetomidine at least 90 minutes prior to start of the MRI

3. Known allergy to dexmedetomidine

4. Medical contraindication to administration of dexmedetomidine

• Unstable cardiac status including life threatening arrhythmias, abnormal cardiac anatomy, significant cardiac dysfunction

• Current use of digoxin

• Moya Moya disease

• New onset stroke

5. American Society of Anesthesiologists (ASA) physical status classification system > II

6. Contraindications to administering sedation

• Active and uncontrolled gastroesophageal reflux

• Active and uncontrolled vomiting

• Current or recent history of apnea

• Active respiratory disease including pneumonia, bronchitis, respiratory syncytial virus infection, asthma exacerbation

• Craniofacial anomaly

7. Unable to have MRI