Early Childhood Caries Clinical Trial
Official title:
A Randomised Controlled Trial of Pediatric Sedation for Dental Treatment Using Oral Midazolam or Placebo
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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