Deep Sedation, Dexmedetomidine
Conditions
Keywords
deep sedation, pediatric, dexmedetomidine, dental treatment
Brief summary
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.
Interventions
DRUGDexmedetomidine
For dexmedetomidine group after ramdomization, an intranasal dose of 2ug/kg dexmedetomidine will be administrated.
DRUGMidazolam
For midazolam group after ramdomization, an intranasal dose of 0.2mg/kg midazolam will be administrated.
Sponsors
Peking University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 7 Years
Healthy volunteers
No
Inclusion criteria
1. children in need of deep sedation for dental treatment aged 3-7 years. 2. anticipated operation time 1-2hours
Exclusion criteria
1. any known medical records with neural or mental disorder 2. any known medical records with severe systemic disorder 3. history of sedation drug administration in recent 1 months 4. any known allergic history of dexmedetomidine, midazolam or propofol 5. morbid obesity 6. history of OSAHS or acute respiratory infection in 2 weeks 7. other conditions which the attending considers to be unfit for the trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| venipuncture acceptance | Day 0 | acceptance while starting the IV line, at most 2 tries |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Observer's Assessment of Alertness/Sedation(MOAA/S) Score | Day 0 | sedation scoring with MOAA/S scale(from intranasal drug administration till discharge) |
| remedial mask induction acceptance | Day 0 | acceptance of the mask induction（for those failed to start the IV before induction） |
| propofol dosage | Day 0 | the total dosage of propofol used from induction till the end of the clinical treatment |
| patients' discomfort | up to 24 hours | any adverse reaction or discomfort complaints of patients will be recorded, such as sneeze, blocked nose, bitter taste, dizziness, rhinalgia, etc. |
| hypoxemia | Day 0 | decreased oxygen saturation up to 90%, and the treatment will also be recorded(if any) |
| peri-operative blood pressure | Day 0 | peri-operative blood pressure states |
| post-operative agitation | Day 0 | emergence agitation assessment with Pediatric Anesthesia Emergence Delirium scale(PAED) from the end of dental procedure till discharge |
| discharge time | Day 0 | time from the end of dental procedure till discharge |
| peri-operative heart rate | Day 0 | peri-operative heart rate |
| times of intra-operative airway assistance | Day 0 | 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. |
| post-operative pain | Day 0 | pain assessment with modified children's hospital of eastern Ontario pain score(m-CHEOPS) from the end of dental procedure till discharge |
Other
| Measure | Time frame | Description |
|---|---|---|
| peri-operative satisfaction | up to 24 hours | satisfaction of surgeon and parents during the whole clinical treatment and follow-up, they will be asked to give a score from 1 to 10, 10 stands for completely satisfied and 1 stands for not satisfied at all |
| post-operative condition of the child | up to 24 hours | complications and behavior changes assessed with Post-Hospitalization Behavior Questionnaire(PHBQ) |
Countries
China
Outcome results
None listed