NCT01795222

Midazolam Efficacy for Sedating Preschoolers Undergoing Dental Treatment

A Randomised Controlled Trial of Pediatric Sedation for Dental Treatment Using Oral Midazolam or Placebo

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Universidade Federal de Goias · Academic / Other
• Sex: All
• Age: 2 Years – 5 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Early Childhood Caries

Interventions

Type	Name	Description
DRUG	Midazolam	Dormire: Midazolam oral solution 2 mg/mL Sedative was administered with a syringe by the anaesthesiologist
DRUG	Placebo	Magistral formula prepared to match Dormire color and consistency, without active ingredients Placebo was administered the same way as midazolam

Timeline

• Start date: 2012-03-01
• Primary completion: 2012-12-01
• Completion: 2013-02-01
• First posted: 2013-02-20
• Last updated: 2013-12-04

Locations

1 site across 1 country: Brazil