Intranasal Versus Nebulized Midazolam in Behaviuor Modification of Preschool Children Undergoing Dental Treatment
NCT ID: NCT05883150
Last Updated: 2023-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
68 participants
INTERVENTIONAL
2022-11-10
2023-08-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Nebulized Midazolam
Nebulized Midazolam
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 Midazolam
Intranasal Midazolam
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
Interventions
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Nebulized Midazolam
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 Midazolam
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 Criteria
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Inclusion Criteria
* 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
* Presence of facial or nasal deformities.
* History of neurological or cognitive alterations.
* Mouth breathers
3 Years
6 Years
ALL
No
Sponsors
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Nourhan M.Aly
OTHER
Responsible Party
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Nourhan M.Aly
Assistant Lecturer of Dental Public Health
Principal Investigators
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Amira A ElKhatib, PhD
Role: PRINCIPAL_INVESTIGATOR
Kafrelsheikh University, Kafrelsheikh, Egypt
Yousr Nader, MSc
Role: PRINCIPAL_INVESTIGATOR
Alexandria University
Locations
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Faculty of Oral and Dental Medicine, Kafrelsheikh University, Kafrelsheikh, Egypt
Kafr ash Shaykh, , Egypt
Countries
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Other Identifiers
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210
Identifier Type: -
Identifier Source: org_study_id