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

Nourhan M.Aly68 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Dental Sedation

Interventions

Nebulized MidazolamDRUG

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

Intranasal MidazolamDRUG

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

Eligibility

Sex: ALLMin age: 3 YearsMax age: 6 Years

Medical Language ↔ Plain English

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

Locations (1)

Faculty of Oral and Dental Medicine, Kafrelsheikh University, Kafrelsheikh, Egypt

Kafr ash Shaykh, Egypt

Outcomes

Primary Outcomes

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

Time frame: throughout the sedation session

Secondary Outcomes

Onset of sedation

The time taken for sedative drugs to start their action will be recorded using a stopwatch

Time frame: 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.

Time frame: during the sedation procedure (after drug administration until reaching satisfactory sedation)

Data from ClinicalTrials.gov

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