Oral Dexmedetomidine for Pediatric MRI Sedation
This study is looking at whether oral dexmedetomidine can be used as the only medicine to help children aged 3 to 6 years old stay still during an MRI scan. Currently, many children need general anesthesia (a medicine that makes you fully unconscious) for an MRI. Researchers want to see if oral dexmedetomidine can provide enough sedation without the risks associated with general anesthesia. The study will compare oral dexmedetomidine to general anesthesia. They will be looking for the right dose of oral dexmedetomidine that helps children complete their MRI without significant side effects. This study plans to enroll 18 participants.
- Study design
- This is an interventional study comparing oral dexmedetomidine to general anesthesia in children aged 3 to 6 years old. It aims to enroll 18 participants.
- What's involved
- Participants will receive either oral dexmedetomidine or general anesthesia for their MRI. Oral dexmedetomidine must be taken at least 90 minutes before the MRI.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will assess data collected from participants until the end of the assessment, up to 70 weeks from the first enrollment.
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Oral Dexmedetomidine in Pediatric MRI
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Soroush Merchant, MD, MS · PRINCIPAL_INVESTIGATOR · Children's Mercy Hospital Kansas City
Who to contact
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What this trial measures
- Oral dexmedetomidine dose with adverse event below moderate risk, as designated by SIVA, to obtain adequate MRI studyFrom date of the first enrollment until the end of assessment of data collected from the last participant, up to 70 weeks
The primary outcome is determining a dose of oral dexmedetomidine that will safely (adverse event (AE) below moderate risk, as designated by the World Society of Intravenous Anesthesia (SIVA) adverse sedation event reporting tool) provide adequate sedation to successfully complete an MRI. Images should have adequate quality and resolution to be interpretated and will be graded by an attending radiologist. Each MRI sequence will be graded 1-3. 1: no-mild motion artifact; 2: moderate motion artifact; 3: severe motion artifact (non-diagnostic).