Intranasal Dexmedetomidine Premedication in Children
Completed · Phase 3
Conditions studied: Preoperative Sedation
In brief
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 minimize distress and to facilitate a smooth induction of anesthesia. Oral Midazolam at 0.5mg/kg dose is more widely used for this purpose . However the commonly used maximum dose is up to 15mg. It also has many limitations such as paradoxical reaction, increased incidence of emergence delirium and negative postoperative behavior changes . Intranasal dexmedetomidine has been used an effective and safe alternative premedication to oral midazolam in children. At a dose of 2micrograms/kg, intranasal dexmedetomidine as premedication resulted in excellent sedation in children aged 5-8yrs with no adverse hemodynamic effects. It has other advantages such as providing analgesia and facilitating smooth emergence from anesthesia. The goal of this study is to find out if intranasal dexmedetomidine is a superior alternative as premedication to oral midazolam in children weighing more than 20kg undergoing general anesthesia for dental rehabilitation.
Key facts
- Study ID
- NCT02250703
- Run by
- University of Mississippi Medical Center
- People needed
- 75
- Starts
- 2014-09-01
- Expected to finish
- 2016-09-01
- Last updated by the study team
- 2017-07-07
Who can join
Age: 5 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Children's of Mississippi/University of Mississipi Medical Center — Jackson, Mississippi, United States
Full record on ClinicalTrials.gov
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