Randomized Controlled Trial of Oral Sedatives for Moderate Sedation in Young Children
Overview
- Phase
- Phase 4
- Intervention
- Midazolam
- Conditions
- Dental Caries
- Sponsor
- Universidade Federal de Goias
- Enrollment
- 41
- Locations
- 1
- Primary Endpoint
- Children's behavior at the dental office after they had dental rehabilitation of early childhood caries when they were under 3 years old
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
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.
Detailed 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.
Investigators
Luciane Ribeiro de Rezende Sucasas da Costa
Associate Professor, Faculty of Dentistry
Universidade Federal de Goias
Eligibility Criteria
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
Exclusion Criteria
- Not provided
Arms & Interventions
Midazolam
Oral midazolam
Intervention: Midazolam
Midazolam/ketamine
Combined midazolam and ketamine
Intervention: Midazolam, ketamine
Protective stabilization
No drug or placebo administered
Intervention: Protective stabilization
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Efficacy of oral sedation with midazolam during children's dental treatment comparing to protective stabilization(1 month)