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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
41
Oral midazolam 1.0 mg/kg (maximum 20 mg)
Children will receive a protective stabilization (physical restrain) with sheet fixed with tapes.
Combined oral midazolam (0.5 mg/kg) and ketamine (3 mg/kg) (MK)
Dental School
Goiânia, Goiás, Brazil
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
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