Early Childhood Caries
Conditions
Keywords
conscious sedation, stress psychological, dental care for children, child behavior, saliva
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.
Interventions
DRUGMidazolam
Dormire: Midazolam oral solution 2 mg/mL Sedative was administered with a syringe by the anaesthesiologist
DRUGPlacebo
Magistral formula prepared to match Dormire color and consistency, without active ingredients Placebo was administered the same way as midazolam
Sponsors
Federal University of Minas Gerais
Universidade Federal de Goias
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 5 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Brazil
Outcome results
None listed