Skip to main content
OpenTrials
Completed

NCT Number: NCT05883150

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dental Sedation

Age range

3 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

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

Kafr ash Shaykh, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. Behavior rating

    Time frame: 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 outcomes

  1. Onset of sedation

    Time frame: 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

  2. Level of sedation

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Nourhan M.Aly

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 31, 2023
Registry last updated
Nov 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.