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

NCT05883150 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2023-11-21

No results posted yet for this study

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

Interventions

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

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

Sponsors & Collaborators

  • Nourhan M.Aly

    lead OTHER

Principal Investigators

  • Amira A ElKhatib, PhD · Kafrelsheikh University, Kafrelsheikh, Egypt

  • Yousr Nader, MSc · Alexandria University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-10
Primary Completion
2023-08-30
Completion
2023-08-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05883150 on ClinicalTrials.gov