Here is the design of a clinical trial:

Official Title: Sedation Versus Protective Stabilization for Dental Treatment of Children With Caries and Negative Behavior at the Dentist: a Non-randomized Clinical Trial

Included conditions:
- Child Behavior
- Dental Caries in Children

Study Armgroups:
- {'label': 'Sedation', 'type': 'EXPERIMENTAL', 'description': 'The child receives sedatives approved for use in an outpatient setting, directed by a doctor, to accomplish the dental treatment.', 'interventionNames': ['Drug: Ketamine 50 MG/ML', 'Drug: Midazolam Hcl 2Mg/Ml Syrup']}
- {'label': 'Control', 'type': 'OTHER', 'description': 'The child does not receive sedatives. As s/he exhibits negative behavior for the dental procedure, s/he will be restrained by a family member and dental team.', 'interventionNames': ['Procedure: Protective stabilization']}

Interventions:
- {'type': 'DRUG', 'name': 'Ketamine 50 MG/ML', 'description': 'Ketamine injectable solution in a concentration of 50.0 mg/mL via oral route; dose of 4.0 mg/kg maximum 100.0 mg', 'armGroupLabels': ['Sedation'], 'otherNames': ['Ketamin S, Cristalia, São Paulo, Brazil']}
- {'type': 'DRUG', 'name': 'Midazolam Hcl 2Mg/Ml Syrup', 'description': 'Midazolam oral solution in a concentration of 2.0 mg/mL via oral route; dose of 0.5 mg/kg, maximum 5.0 mg when associated with ketamine;', 'armGroupLabels': ['Sedation'], 'otherNames': ['Dormire oral solution, Cristalia, Sao Paulo, Brazil']}
- {'type': 'PROCEDURE', 'name': 'Protective stabilization', 'description': "The legal guardian or accompanying person appointed by the legal guardian should sit in the dental chair with the child and contain leg and arm movements. A dental assistant keeps the child's head contained during care.", 'armGroupLabels': ['Control']}

Primary Outcomes:
- {'measure': 'Child behavior during the dental treatment', 'description': "Children's behavior assessed by OSUBRS (Ohio State University Behavioral Rating Scale) in digital videos recorded during the administration. Scores: 1 - quiet, 2 - cry with movement, 3 - movement without cry; 4 - struggling. The higher the percentage of time of care in which the child behaves quietly, the better their behavior. Measurements for each group will be synthesized as mean (or median) and standard deviation (or interquartile range).", 'timeFrame': 'Participants will be followed for the duration of the dental session, an expected average of 40 minutes'}

Please estimate the sample size based on the assumption: 
A power of 80%, a significance level of 5% (one-tailed), and a 20% addition to account for losses after 12 months of follow-up.
Sample size
        Preliminary estimates indicate that, based on adults prescribed an anxiolytic, the minimum clinically relevant difference in the VAS scale is between 10 and 15Â mm [26]. This study would require a sample size of 63 for each group to achieve a power of 80% and a significance level of 5% (one-tailed) to detect an actual difference average between the intervention groups of 15Â mm (assuming a grouped standard deviation of 30 units). To avoid significant losses in the final sample size, after 12Â months of follow-up, we will add 20% to each group, which implies 76 children/group, i.e., a total sample size of 152 children.
        According to age, the estimated sample will be distributed in 38 children aged 2â3Â years and 38 children of 4â6Â years in each center to perform subgroup analysis.
        The sample size will be recalculated when the minimum number of 30 cases in each center is reached, based on the values observed in this study's conditions (interim analysis).