Status:

COMPLETED

Nebulized Midazolam, Dexmedetomidine, and Their Combination in Sedation of Preschoolers Undergoing Dental Treatment

Lead Sponsor:

Nourhan M.Aly

Collaborating Sponsors:

Alexandria University

Conditions:

Dental Anxiety

Eligibility:

All Genders

4-6 years

Phase:

PHASE2

Brief Summary

The aim of the study is to evaluate the effect of nebulized Midazolam, Dexmedetomidine, and their combination as procedural, moderate sedative agents in preschoolers undergoing dental treatment.

Detailed Description

Dental anxiety and fear related behaviors are global problems in Pediatric Dentistry. Preschoolers represent a dental behavior management problem and there is always a debate over the best behavioral ...

Eligibility Criteria

Inclusion

  • Age range 4-6 years
  • 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

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

Key Trial Info

Start Date :

November 27 2017

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 22 2019

Estimated Enrollment :

72 Patients enrolled

Trial Details

Trial ID

NCT03827408

Start Date

November 27 2017

End Date

December 22 2019

Last Update

January 22 2020

Active Locations (1)

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Faculty of Dentistry, Alexandria University

Alexandria, Egypt, 21512