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

Nourhan M.Aly

Status and phase: Completed; Phase 3; Phase 2

Conditions: Dental Sedation

Treatments: Drug: Nebulized Midazolam; Drug: Intranasal Midazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT05883150

210

Details and patient eligibility

About

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.

Enrollment: 68 patients

Sex: All

Ages: 3 to 6 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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68 participants in 2 patient groups

Nebulized Midazolam

Experimental group

Treatment:

Drug: Nebulized Midazolam

Intranasal Midazolam

Active Comparator group

Treatment:

Drug: Intranasal Midazolam