It is important to choose an appropriate analgesia/sedation technique in pediatric dental treatment. Premedication combined with intravenous anesthesia is often used in deep sedation technique for pediatric dental treatment and it's a routine in most hospitals. Deep sedation has its unique advantages such as avoiding the airway damage with an enhanced recovery. Dexmedetomidine is suitable for intranasal mucosal administration as a premedication drug. It has been proved with several beneficial characteristics in other clinical procedures. This study intends to further explore the characteristics of nasal dexmedetomidine as premedication in pediatric oral treatment under deep sedation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
100
For dexmedetomidine group after ramdomization, an intranasal dose of 2ug/kg dexmedetomidine will be administrated.
For midazolam group after ramdomization, an intranasal dose of 0.2mg/kg midazolam will be administrated.
Peking University Hospital of Stomatology
Beijing, Beijing Municipality, China
venipuncture acceptance
acceptance while starting the IV line, at most 2 tries
Time frame: Day 0
Observer's Assessment of Alertness/Sedation(MOAA/S) Score
sedation scoring with MOAA/S scale(from intranasal drug administration till discharge)
Time frame: Day 0
remedial mask induction acceptance
acceptance of the mask induction（for those failed to start the IV before induction）
Time frame: Day 0
propofol dosage
the total dosage of propofol used from induction till the end of the clinical treatment
Time frame: Day 0
patients' discomfort
any adverse reaction or discomfort complaints of patients will be recorded, such as sneeze, blocked nose, bitter taste, dizziness, rhinalgia, etc.
Time frame: up to 24 hours
hypoxemia
decreased oxygen saturation up to 90%, and the treatment will also be recorded(if any)
Time frame: Day 0
peri-operative blood pressure
peri-operative blood pressure states
Time frame: Day 0
peri-operative heart rate
peri-operative heart rate
Time frame: Day 0
times of intra-operative airway assistance
Any intra-operative airway assistance in need which aims to improve ventilation will be recorded, including jaw lifting, suction, mask ventilation and intubation. Specific type of assistance will also be recorded in detail.
Time frame: Day 0
post-operative pain
pain assessment with modified children's hospital of eastern Ontario pain score(m-CHEOPS) from the end of dental procedure till discharge
Time frame: Day 0
post-operative agitation
emergence agitation assessment with Pediatric Anesthesia Emergence Delirium scale(PAED) from the end of dental procedure till discharge
Time frame: Day 0
discharge time
time from the end of dental procedure till discharge
Time frame: Day 0
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