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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nebulized Midazolam | Experimental |
| |
| Intranasal Midazolam | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nebulized Midazolam | Drug | 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amira A ElKhatib, PhD | Kafrelsheikh University, Kafrelsheikh, Egypt | Principal Investigator |
| Yousr Nader, MSc | Alexandria University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Oral and Dental Medicine, Kafrelsheikh University, Kafrelsheikh, Egypt | Kafr ash Shaykh | Egypt |
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| Intranasal Midazolam | Drug | 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 |
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The level of sedation Agitated will be scored using a Five point sedation scale
| during the sedation procedure (after drug administration until reaching satisfactory sedation) |