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

NCT05883150 | Completed Phase 2

• 1 other identifier: 210
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Sedation

Outcome Measures

Primary Outcomes (1)

• 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

  throughout the sedation session

Secondary Outcomes (2)

• Onset of sedation

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

• Level of sedation

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

Study Arms (2)

Nebulized Midazolam

EXPERIMENTAL

Drug: Nebulized Midazolam

Intranasal Midazolam

ACTIVE COMPARATOR

Drug: Intranasal Midazolam

Interventions

Nebulized Midazolam DRUG

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

Nebulized Midazolam

Intranasal Midazolam DRUG

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

Intranasal Midazolam

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Dental treatment indicated under general anesthesia.
• Presence of facial or nasal deformities.
• History of neurological or cognitive alterations.
• Mouth breathers

Sponsors & Collaborators

• Nourhan M.Aly: lead

Study Sites (1)

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

Kafr ash Shaykh, Egypt

Location

Study Officials

• Amira A ElKhatib, PhD

  Kafrelsheikh University, Kafrelsheikh, Egypt

  PRINCIPAL INVESTIGATOR

• Yousr Nader, MSc

  Alexandria University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Lecturer of Dental Public Health

Study Record Dates

• First Submitted: May 20, 2023
• First Posted: May 31, 2023
• Study Start: November 10, 2022
• Primary Completion: August 30, 2023
• Study Completion: August 30, 2023
• Last Updated: November 21, 2023

Record last verified: 2023-11

Locations

EG (1)