Status:

COMPLETED

Midazolam Efficacy for Sedating Preschoolers Undergoing Dental Treatment

Lead Sponsor:

Universidade Federal de Goias

Collaborating Sponsors:

Federal University of Minas Gerais

Conditions:

Early Childhood Caries

Eligibility:

All Genders

2-5 years

Phase:

PHASE4

Brief Summary

Evaluation of oral midazolam to improve children's behavior and reduces the stress and anxiety during dental treatment

Detailed Description

This study was initially planned to investigate three paediatric sedation regimens that also included the following arms: * oral midazolam + oral ketamine + inhaled sevoflurane * oral midazolam + ora...

Eligibility Criteria

Inclusion

  • Children aged 2 to 5 years old, American Society of Anesthesiologists (ASA) I or II, healthy, with no cognitive impairment, presenting with early childhood caries

Exclusion

  • Children presenting with at least one of the following:
  • airway obstruction and/or oral breathing;
  • recent use of systemic corticosteroids
  • needing less than two dental restorations;
  • previous dental sedation.

Key Trial Info

Start Date :

March 1 2012

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 1 2013

Estimated Enrollment :

18 Patients enrolled

Trial Details

Trial ID

NCT01795222

Start Date

March 1 2012

End Date

February 1 2013

Last Update

December 4 2013

Active Locations (1)

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Faculty of Dentistry, Federal University of Goias

Goiânia, Goiás, Brazil, 74605220