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

Intranasal Versus Nebulized Midazolam in Behaviuor Modification of Preschool Children Undergoing Dental Treatment: A Randomized Clinical Trial

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 Overview

• Status: Completed
• Conditions: Dental Sedation
• Intervention / Treatment: Drug: Nebulized Midazolam; Drug: Intranasal Midazolam

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Kafr Ash Shaykh, Egypt
    • Faculty of Oral and Dental Medicine, Kafrelsheikh University, Kafrelsheikh, Egypt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nebulized Midazolam	Drug: 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
Active Comparator: Intranasal Midazolam	Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Onset of sedation	The time taken for sedative drugs to start their action will be recorded using a stopwatch	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.	during the sedation procedure (after drug administration until reaching satisfactory sedation)

Collaborators and Investigators

• Sponsor: Nourhan M.Aly
• Investigators: Principal Investigator: Amira A ElKhatib, PhD, Kafrelsheikh University, Kafrelsheikh, Egypt; Principal Investigator: Yousr Nader, MSc, Alexandria University

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2022
• Primary Completion (Actual): August 30, 2023
• Study Completion (Actual): August 30, 2023

Study Registration Dates

• First Submitted: May 20, 2023
• First Submitted That Met QC Criteria: May 20, 2023
• First Posted (Actual): May 31, 2023

Study Record Updates

• Last Update Posted (Estimated): November 21, 2023
• Last Update Submitted That Met QC Criteria: November 17, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Midazolam
• Other Study ID Numbers: 210

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No