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Not Yet Recruiting
NCT05619627
Oral Dexmedetomidine in Pediatric MRI
Conditions: Anesthesia
Sex: All
Ages: 4 Months – 6 Years
Healthy volunteers: 1
Phase: PHASE1
Enrollment: 120
Sponsor: Children's Mercy Hospital Kansas City
Location: United States
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:Subjects ages 4 months to 6 yearsUndergoing a clinically indicated MRI with anesthesiaExclusion Criteria:Refusal to take oral dexmedetomidineInability to take dexmedetomidine at least 90 minutes prior to start of the MRIKnown allergy to dexmedetomidineMedical contraindication to administration of dexmedetomidineUnstable cardiac status including life threatening arrhythmias, abnormal cardiac anatomy, significant cardiac dysfunctionCurrent use of digoxinMoya Moya diseaseNew onset strokeAmerican Society of Anesthesiologists (ASA) physical status classification system > IIContraindications to administering sedationActive and uncontrolled gastroesophageal refluxActive and uncontrolled vomitingCurrent or recent history of apneaActive respiratory disease including pneumonia, bronchitis, respiratory syncytial virus infection, asthma exacerbationCraniofacial anomalyUnable to have MRI
Source: ClinicalTrials.gov (NCT05619627). StuddyBuddy aggregates publicly available trial information.