Intranasal Dexmedetomidine for Deep-sedated Pediatric Dental Patients

Study Overview
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Brief Summary
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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.

Official Title
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Intranasal Dexmedetomidine Versus Midazolam for Premedication in Deep-sedated Pediatric Dental Patients: a Double-blinded, Prospective, Randomized Controlled Trial

Conditions
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Deep Sedation, Dexmedetomidine

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: Midazolam


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: children in need of deep sedation for dental treatment aged 3-7 years. anticipated operation time 1-2hours Exclusion Criteria: any known medical records with neural or mental disorder any known medical records with severe systemic disorder history of sedation drug administration in recent 1 months any known allergic history of dexmedetomidine, midazolam or propofol morbid obesity history of OSAHS or acute respiratory infection in 2 weeks other conditions which the attending considers to be unfit for the trial

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dexmedetomidine<br>2ug/kg intranasal atomized dexmedetomidine | Drug: Dexmedetomidine<br>* For dexmedetomidine group after ramdomization, an intranasal dose of 2ug/kg dexmedetomidine will be administrated.<br>|
| Active Comparator: midazolam<br>0.2mg/kg intranasal atomized midazolam | Drug: Midazolam<br>* For midazolam group after ramdomization, an intranasal dose of 0.2mg/kg midazolam will be administrated.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| venipuncture acceptance | acceptance while starting the IV line, at most 2 tries | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Observer's Assessment of Alertness/Sedation(MOAA/S) Score | sedation scoring with MOAA/S scale(from intranasal drug administration till discharge) | Day 0 | 
| remedial mask induction acceptance | acceptance of the mask induction（for those failed to start the IV before induction） | Day 0 | 
| propofol dosage | the total dosage of propofol used from induction till the end of the clinical treatment | 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. | up to 24 hours | 
| hypoxemia | decreased oxygen saturation up to 90%, and the treatment will also be recorded(if any) | Day 0 | 
| peri-operative blood pressure | peri-operative blood pressure states | Day 0 | 
| peri-operative heart rate | peri-operative heart rate | 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. | 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 | Day 0 | 
| post-operative agitation | emergence agitation assessment with Pediatric Anesthesia Emergence Delirium scale(PAED) from the end of dental procedure till discharge | Day 0 | 
| discharge time | time from the end of dental procedure till discharge | Day 0 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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deep sedation, pediatric, dexmedetomidine, dental treatment