Nebulized Midazolam, Dexmedetomidine, and Their Combination in Sedation of Preschoolers Undergoing Dental Treatment

Study Overview
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Brief Summary
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The aim of the study is to evaluate the effect of nebulized Midazolam, Dexmedetomidine, and their combination as procedural, moderate sedative agents in preschoolers undergoing dental treatment.

Detailed Description
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Dental anxiety and fear related behaviors are global problems in Pediatric Dentistry. Preschoolers represent a dental behavior management problem and there is always a debate over the best behavioral management technique for preschoolers undergoing dental treatment. Moderate sedation is considered as an acceptable option. Children who need treatment under local anesthesia, for thirty minutes will be included in the study. A total of 72 uncooperative pediatric dental patients, of age range 4-6 years, will be selected from the Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Alexandria University, Egypt. The participants will be randomly allocated into 3 groups that will undergo a procedural sedation session via a nebulizer. Children of group I will receive nebulized solution of 0.5 mg/kg Midazolam, Group II will receive nebulized solution of 5µg/kg Dexmedetomidine, and Group III will receive a nebulized solution of 0.3 mg/kg Midazolam and 3µg/kg Dexmedetomidine respectively.

Official Title
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Nebulized Midazolam, Dexmedetomidine, and Their Combination in Sedation of Preschoolers Undergoing Dental Treatment: A Randomized Clinical Trial

Conditions
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Dental Anxiety

Intervention / Treatment
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* Drug: Midazolam group (MDZ)
* Drug: Dexmedetomidine group (DEX)
* Drug: Combination of Midazolam and Dexmedetomidine (MDZ/DEX)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age range 4-6 years Frankl scale score 2. ASA I or II physical status. Dental intervention under local anesthesia not requiring more than 30 minutes. No previous dental experience. Parent/guardians written consent. Exclusion Criteria: Dental treatment indicated under general anesthesia. Presence of facial deformities. History of neurological or cognitive alterations. Mouth breathers.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 6 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The participants will be randomly allocated into 3 groups that will undergo a procedural sedation session via a nebulizer. Children of group I will receive nebulized solution of 0.5 mg/kg Midazolam, Group II will receive nebulized solution of 5µg/kg Dexmedetomidine, and Group III will receive a nebulized solution of 0.3 mg/kg Midazolam and 3µg/kg Dexmedetomidine respectively.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Midazolam group (MDZ)<br>Twenty four pediatric dental patients will receive a procedural sedation session, using Nebulized solution of 0.5 mg/kg Midazolam. | Drug: Midazolam group (MDZ)<br>* IV Ampules of Dormicum 15mg/ 3ml, Hoffman-La Rouche Ltd., Basel, Switzerland<br>|
| Experimental: Dexmedetomidine group (DEX)<br>Twenty four pediatric dental patients will receive a procedural sedation session, using Nebulized solution of 5µg/kg Dexmedetomidine. | Drug: Dexmedetomidine group (DEX)<br>* IV Ampules of Precedex 4mcg/ml, Hospira. Inc., Lake Forest,IL USA.<br>|
| Experimental: Combination of Midazolam and Dexmedetomidine (MDZ/DEX)<br>Twenty four pediatric dental patients will receive a procedural sedation session, using Nebulized solution of 0.3 mg/kg Midazolam, and 3µg/kg Dexmedetomidine respectively. | Drug: Combination of Midazolam and Dexmedetomidine (MDZ/DEX)<br>* Combination of Nebulized solution of 0.3 mg/kg Midazolam, and 3µg/kg Dexmedetomidine respectively.(<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Facemask acceptance during drug delivery | It will be evaluated according to Zanaty & Metainy as: poor (terrified, crying and combative), fair (moderate fear of mask not calmed with reassurance), good (slight fear of mask, easily reassured) or excellent (unafraid, cooperative and accepts mask readily) | during the sedation procedure | 
| Effect of sedation on children's future behavior | Each child's behavior will be reassessed in the follow-up sessions and compared to that at baseline (before dental treatment) using Frankl scale (ranges from 0-4) | after one week in the follow-up session | 
| The 'ease of treatment completion' sing separate five-point scales. | This will be measured using separate five-point scales according to Surendar et al: Score 5 indicates an excellent quiet and cooperative child while score 1 indicates Prohibitive active resistance and crying; treatment cannot be rendered. | immediately after completion of the dental treatment procedures. | 
| Post-operative effects of the sedation | This will be assessed according to Modified Vernon et al. | immediately after completion of the dental treatment procedures. | 
| Analgo-sedative effect of each drug | Onset of Sedation from drug administration until the onset of satisfactory sedation | during the sedation procedure (time taken from drug administration till reaching satisfactory sedation) | 
| Analgo-sedative effect of each drug | Sedation level using Modified Observer's Assessment of Alertness/Sedation Scale. The scale is composed of 4 categories (each has scores ranging from 1-5). The categories are responsiveness, speech, facial expression and eyes. The final score is the sum of scores: the totally awake score is 20/20 and the deeply sedated score is 9/20 | during the sedation procedure (after drug administration until reaching satisfactory sedation) | 
| Analgo-sedative effect of each drug | The analgesic effect of the sedative drugs will be assessed using Face, Legs, Activity, Cry, Consolability scale (FLACC). The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2. | during local anesthesia injection to start the operative procedure | 
| Analgo-sedative effect of each drug | The duration of sedation: defined as the onset of satisfactory sedation until the time of meeting discharge criteria according to the American Academy of Pediatric Dentistry. | during the sedation procedure (from its onset till meeting discharge criteria) | 
| Analgo-sedative effect of each drug. | Assessment of the most common procedural side effects such as (hypoxia, respiratory depression, agitation, arrhythmia, bradycardia, hypotension or hypertension, shivering, nausea and vomiting) will be recorded. | during the sedation procedure (from its onset till meeting discharge criteria) | 
| Amnesic effect of sedative agents. | Anterograde amnesia: will be assessed according to a modification of Bulach et al. | immediately after completion of the dental treatment procedures. | 
| Hemodynamic response of sedative agents. | Vital sign: Blood pressure (in mmHg) will be monitored using a sphygmomanometer. | during the sedation procedure (from its onset till meeting discharge criteria) | 
| Hemodynamic response of sedative agents. | Vital sign: Heart rate will be counted | during the sedation procedure (from its onset till meeting discharge criteria) | 
| Hemodynamic response of sedative agents. | Vital sign: Oxygen saturation will be monitored using an oximeter | during the sedation procedure (from its onset till meeting discharge criteria) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nebulized Dexmedetomidine, Nebulized Midazolam, Moderate sedation, Dental procedural sedation, Pediatric dentistry