Dental Sedation
Conditions
Brief summary
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.
Interventions
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
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
Sponsors
Nourhan M.Aly
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
3 Years to 6 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Behavior rating | throughout the sedation session | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Onset of sedation | during the sedation procedure (after drug administration until reaching satisfactory sedation) | The time taken for sedative drugs to start their action will be recorded using a stopwatch |
| Level of sedation | during the sedation procedure (after drug administration until reaching satisfactory 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. |
Countries
Egypt
Outcome results
None listed