Intranasal Versus Nebulized Midazolam in Behaviuor Modification of Preschool Children Undergoing Dental Treatment

Study Overview
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Brief Summary
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The aim of the current study is to compare the effect of intranasal versus nebulized route of administration of midazolam as moderate sedative agents in preschoolers undergoing dental treatment.

Official Title
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Intranasal Versus Nebulized Midazolam in Behaviuor Modification of Preschool Children Undergoing Dental Treatment: A Randomized Clinical Trial

Conditions
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Dental Sedation

Intervention / Treatment
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* Drug: Nebulized Midazolam
* Drug: Intranasal Midazolam


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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/guardian's written consent. Exclusion Criteria: Dental treatment indicated under general anesthesia. Presence of facial or nasal deformities. History of neurological or cognitive alterations. Mouth breathers

Ages Eligible for Study
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Minimum Age: 3 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nebulized Midazolam<br> | Drug: Nebulized Midazolam<br>* All the drug solutions will be freshly prepared on the day of sedation session. Depending on the dosage calculated from the weight of each child The sedative drug, the dosage will be diluted with an equal volume by adding distilled water. The child will be seated in an upright position on the dental chair. Before placing the mask of the nebulizer, the child will be coached into proper breathing pattern<br>|
| Active Comparator: Intranasal Midazolam<br> | Drug: Intranasal Midazolam<br>* All the drug solutions will be freshly prepared on the day of sedation session. Depending on the dosage calculated from the weight of each child, For children who will receive midazolam using the atomization device attached to a three-ml syringe, the child sitting reclined in knee-to-knee position. Half of the dose will be sprayed in the right nostril and the other half will be sprayed in the left nostril to double the absorptive surface area by short and quick puffs<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Behavior rating | This will be recorded using the Modified Houpt scale for behavior rating; Sleep, head/oral resistance, crying and overall behavior will be scored on a 6-point scale ranging from 1-6 with higher scores indicating better behavior | throughout the sedation session | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Onset of sedation | The time taken for sedative drugs to start their action will be recorded using a stopwatch | during the sedation procedure (after drug administration until reaching satisfactory sedation) | 
| Level of sedation | The level of sedation Agitated will be scored using a Five point sedation scale Agitated - Clinging to parent/crying Alert - Awake, not clinging to parent/no cry Calm - Sitting or lying comfortably with eyes spontaneously open eyes spontaneously closed but responds Drowsy: Comfortable with minor stimuli Asleep: Eyes closed, arousable, does not respond to minor stimuli. | during the sedation procedure (after drug administration until reaching satisfactory sedation) |