Midazolam Efficacy for Sedating Preschoolers Undergoing Dental Treatment

Universidade Federal de Goias18 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Early Childhood Caries

Interventions

MidazolamDRUG

Dormire: Midazolam oral solution 2 mg/mL Sedative was administered with a syringe by the anaesthesiologist

PlaceboDRUG

Magistral formula prepared to match Dormire color and consistency, without active ingredients Placebo was administered the same way as midazolam

Eligibility

Sex: ALLMin age: 2 YearsMax age: 5 Years

Medical Language ↔ Plain English

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.

Locations (1)

Faculty of Dentistry, Federal University of Goias

Goiânia, Goiás, Brazil

Outcomes

Primary Outcomes

child stress

level of salivary cortisol according to the ELISA

Time frame: At child's awaking and arrival in the dental office, 25 min after local anesthetic administration, 25 min after dental session completion

Secondary Outcomes

Child behaviour

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)

Time frame: every minute during the dental treatment up to the end of the dental session, which is estimated in 60 minutes

sedative safety

assessed according to the World SIVA adverse sedation event reporting tool

Time frame: during and twenty four hours after the procedure

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.