Efficacy of Moderate Sedation for Dental Treatment of Young Children

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Controlled Trial of Oral Sedatives for Moderate Sedation in Young Children

Conditions
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Dental Caries, Child Behavior, Conscious Sedation Failure During Procedure

Intervention / Treatment
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* Drug: Midazolam
* Behavioral: Protective stabilization
* Drug: Midazolam, ketamine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 36 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Midazolam<br>Oral midazolam | Drug: Midazolam<br>* Oral midazolam 1.0 mg/kg (maximum 20 mg)<br>* Other names: Dormire, Cristalia, Sao Paulo, Brazil;|
| Experimental: Midazolam/ketamine<br>Combined midazolam and ketamine | Drug: Midazolam, ketamine<br>* Combined oral midazolam (0.5 mg/kg) and ketamine (3 mg/kg) (MK)<br>* Other names: Ketamin S+, Cristalia, Sao Paulo, Brazil;|
| Other: Protective stabilization<br>No drug or placebo administered | Behavioral: Protective stabilization<br>* Children will receive a protective stabilization (physical restrain) with sheet fixed with tapes.<br>* Other names: No drug administered;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Children's behavior at the dental office after they had dental rehabilitation of early childhood caries when they were under 3 years old |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of oral sedation with midazolam during children's dental treatment comparing to protective stabilization |  | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preschool children