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NCT05619627
Oral Dexmedetomidine in Pediatric MRI
Conditions: Anesthesia
Sex: All
Ages: 3 Years – 6 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 18
Sponsor: Soroush Merchant
Location: Children's Mercy Hospital Kansas City Missouri
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.
Eligibility Criteria
Inclusion Criteria:
1. Participants 3-6 years old, male and female, all races and ethnicities
2. Requiring a clinically indicated MRI with general anesthesia
Exclusion Criteria:
1. Refusal to take oral dexmedetomidine
2. Known allergy to dexmedetomidine
3. Inability to take dexmedetomidine at least 90 minutes prior to start of the MRI
4. Medical contraindications to administration of dexmedetomidine including:
1. Unstable cardiac status including life threatening arrhythmias, abnormal cardiac anatomy, significant cardiac dysfunction
2. Current use of digoxin
3. Moya Moya disease
4. New onset stroke
5. American Society of Anesthesiologists (ASA) physical status classification \> II
6. Contraindications to administering sedation including:
1. Active and uncontrolled gastroesophageal reflux
2. Active and uncontrolled vomiting
3. Current or recent history of apnea
4. Active respiratory disease including pneumonia, bronchitis, respiratory syncytial virus infection, asthma exacerbation
5. Craniofacial anomalies
7. Inability to have MRI scans
8. Non-English speaking volunteers
Source: ClinicalTrials.gov (NCT05619627). StuddyBuddy aggregates publicly available trial information.