Efficacy of Moderate Sedation for Dental Treatment of Young Children
This trial is active, not recruiting.
|Conditions||dental caries, child behavior, conscious sedation failure during procedure|
|Treatments||midazolam, protective stabilization, midazolam, ketamine|
|Sponsor||Universidade Federal de Goias|
|Collaborator||Conselho Nacional de Desenvolvimento Científico e Tecnológico|
|Start date||June 2008|
|End date||December 2010|
|Trial size||41 participants|
|Trial identifier||NCT00902395, UFG SAP 18189|
There is lack of clinical trials on pediatric dental sedation. The purpose of this study is to test (using a randomized controlled trial design) the hypothesis that young children behavior during dental treatment improves with oral midazolam sedation. A further aim of this study was is explore whether behavior also changes over sessions needed to dental treatment completion.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
Children's behavior at the dental office after they had dental rehabilitation of early childhood caries when they were under 3 years old
time frame: 2 years
Efficacy of oral sedation with midazolam during children's dental treatment comparing to protective stabilization
time frame: 1 month
Male or female participants from 12 months up to 36 months old.
Inclusion Criteria: - Healthy children (ASA PS 1) - Children under 36 months old - Children presenting early childhood caries - Children with no history of dental treatment Exclusion criteria: - Lost to follow-up
|Official title||Randomized Controlled Trial of Oral Sedatives for Moderate Sedation in Young Children|
|Principal investigator||Luciane R Costa, DDS, MS, PhD|
|Description||There is a lack of clinical trials on pediatric dental sedation in children 3 years old and under. We investigated whether young children's behavior improves during dental treatment with combined oral ketamine and midazolam compared to midazolam alone or no sedation. Healthy children under 36 months of age, presenting early childhood caries and referred to a pediatric dental sedation clinic were randomly assigned to receive combined midazolam (0.5 mg/kg) and ketamine (3 mg/kg) (MK), oral midazolam (1.0 mg/kg) (MS), or protective stabilization without sedative (PS). One observer scored children's behavior using the Ohio State University Behavior Rating Scale (OSUBRS) at determined points in a dental exam (no sedative) and treatment session. Data were analyzed using non-parametric bivariate tests.|
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