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

Phase 2

Completed

• Conditions: Dental Sedation
• Interventions: Drug: Intranasal Midazolam; Drug: Nebulized Midazolam

• Registration Number: NCT05883150
• Lead Sponsor: Nourhan M.Aly

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-10
• Study First Submitted: 2023-05-20
• Study First Submitted QC: 2023-05-20
• Study First Posted: 2023-05-31
• Primary Completion: 2023-08-30
• Study Completion: 2023-08-30
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-17
• Last Update Posted: 2023-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intranasal Midazolam	Intranasal Midazolam	-
Nebulized Midazolam	Nebulized Midazolam	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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

Trial Locations

Locations (1)

Faculty of Oral and Dental Medicine, Kafrelsheikh University, Kafrelsheikh, Egypt; 🇪🇬 Kafr Ash Shaykh, Egypt