Status:
COMPLETED
Intranasal Dexmedetomidine Premedication in Children
Lead Sponsor:
University of Mississippi Medical Center
Conditions:
Preoperative Sedation
Eligibility:
All Genders
5-18 years
Phase:
PHASE3
Brief Summary
BACKGROUND INFORMATION AND RATIONALE Pediatric patients scheduled for dental procedures under general anesthesia can have significant anxiety before the procedure. They are commonly pre medicated to ...
Detailed Description
After Institutional Review Board (IRB) approval and written informed consent from patients' parents or legally authorized representative, 80 children older than 5yrs and weighing more than 20kg, ASA p...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Children older than 5yrs and weighing more than 20kg , who are scheduled for ambulatory dental rehabilitation at Batson operating rooms.
- ASA classification 1 or 2
- Exclusion Criteria
- Known allergy to midazolam, dexmedetomidine,morphine, fentanyl, sevoflurane and propofol.
- uncorrected congenital heart disease or history of cardiac arrhythmia,
- children at risk for airway obstruction (OSA or cranio facial syndrome),
- pregnant minors
Exclusion
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT02250703
Start Date
September 1 2014
End Date
September 1 2016
Last Update
July 7 2017
Active Locations (1)
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1
Children's of Mississippi/University of Mississipi Medical Center
Jackson, Mississippi, United States, 39216