Midazolam Efficacy for Sedating Preschoolers Undergoing Dental Treatment

Phase 4

Completed

• Conditions: Early Childhood Caries
• Interventions: Drug: Placebo; Drug: Midazolam

• Registration Number: NCT01795222
• Lead Sponsor: Universidade Federal de Goias

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 + oral ketamine + inhaled oxygen So, the former protocol found in the PRS registry was called PedSed-III and included the aforementioned arms.

However, there was a long delay in fund release from the funding agency (State of Goias Research Foundation - FAPEG). Although the grant was approved in the beginning of 2013, resources were released in November 2013.

We could not wait for funding release because this study was part of the MS dissertation of the principal investigator that was supposed to be concluded in the first semester of 2013. Then we decided to develop a less robust study, including only two arms: oral midazolam versus oral placebo. The other variables of the study did not change. We finished this two-arms study and have the final results for that comparison.

Study Timeline

• Study Start: 2012-03
• Primary Completion: 2012-12
• Study First Submitted: 2012-12-19
• Study Completion: 2013-02
• Study First Submitted QC: 2013-02-17
• Study First Posted: 2013-02-20
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-02
• Last Update Posted: 2013-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• 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 Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
placebo	Placebo	placebo oral syrup twenty minutes before starting the procedure
Oral Midazolam	Midazolam	Midazolam oral syrup 1mg/Kg twenty minutes before starting the procedure

Primary Outcome Measures

Name	Time	Method
child stress	At child's awaking and arrival in the dental office, 25 min after local anesthetic administration, 25 min after dental session completion	level of salivary cortisol according to the ELISA

Secondary Outcome Measures

Name	Time	Method
Child behaviour	every minute during the dental treatment up to the end of the dental session, which is estimated in 60 minutes	child dental treatment is video recorded and then a masked observer watches the videos and categorize child behavior according to the Ohio State University Behavioral Rating Scale (OSUBRS)
sedative safety	during and twenty four hours after the procedure	assessed according to the World SIVA adverse sedation event reporting tool

Trial Locations

Locations (1)

Faculty of Dentistry, Federal University of Goias; 🇧🇷 Goiânia, Goias, Brazil