Midazolam Efficacy for Sedating Preschoolers Undergoing Dental Treatment

Study Overview
=================
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.

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

Conditions
-----------------
Early Childhood Caries

Intervention / Treatment
-----------------
* Drug: Midazolam
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 5 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oral Midazolam<br>Midazolam oral syrup 1mg/Kg twenty minutes before starting the procedure | Drug: Midazolam<br>* Dormire: Midazolam oral solution 2 mg/mL Sedative was administered with a syringe by the anaesthesiologist<br>* Other names: Brand: Dormire (Cristalia, Sao Paulo, Brazil);|
| Placebo Comparator: placebo<br>placebo oral syrup twenty minutes before starting the procedure | Drug: Placebo<br>* Magistral formula prepared to match Dormire color and consistency, without active ingredients Placebo was administered the same way as midazolam<br>* Other names: Magistral formula;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| child stress | level of salivary cortisol according to the ELISA | At child's awaking and arrival in the dental office, 25 min after local anesthetic administration, 25 min after dental session completion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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 | during and twenty four hours after the procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
conscious sedation, stress psychological, dental care for children, child behavior, saliva