Abstract
BackgroundUncooperative children may need to receive dental treatment under sedation, which is indicated when nonpharmacological behavior guidance is unsuccessful. There are randomized controlled trials (RCTs) comparing different sedative protocols for dental procedures; however, the evidence for superiority of one form over another is weak. The primary aim of this study is to investigate the efficacy of intranasally administered ketamine plus midazolam for the dental treatment of children.MethodsWe have designed a three-armed, parallel RCT to assess intranasal sedation using ketamine/midazolam in terms of the following measures: efficacy, safety, and cost-effectiveness. Two- to 6-year-old healthy children, referred for dental treatment in a dental sedation center in Brazil due to uncooperative behavior and requiring restorative dental procedures, will be recruited. Each child will be randomly assigned to one of the three groups: A – Intranasal administration of ketamine (4.0 mg/kg, maximum 100 mg) and midazolam (0.2 mg/kg, maximum 5.0 mg); B – Oral administration of ketamine (4.0 mg/kg, maximum 100 mg) and midazolam (0.5 mg/kg, maximum 20 mg); and C – Oral administration of midazolam (1.0 mg/kg, maximum 20 mg). The primary outcome is the child’s behavior assessed through an observational scale using digital videos of the restorative dental treatment under sedation. The secondary outcomes are as follows: acceptance of sedative administration; memory of intraoperative events; the child’s stress; adverse events; the child’s pain during the procedure; the parent’s, dentists’, and child’s perceptions of sedation; and economic analysis. Measures will be taken at baseline and drug administration and during and after the dental procedure. The necessary sample size was estimated to be 84 children after a blinded interim analysis of the first 30 cases.DiscussionThis study will provide data that can substantially add to science and pediatric dentistry as it examines the effect of sedative regimes from different perspectives (outcomes).Trial registrationClinicalTrials.gov, identifier: NCT02447289. Registered on 11 May 2015, named “Midazolam and Ketamine Effect Administered Through the Nose for Sedation of Children for Dental Treatment (NASO).”
Highlights
Uncooperative children may need to receive dental treatment under sedation, which is indicated when nonpharmacological behavior guidance is unsuccessful
A Data Monitoring Committee and external auditing are not required by local standards, because this trial is small, has a short duration and known risks. The conception of this protocol was based on the following two main goals: to determine a suitable sedative regime for young children undergoing dental treatment and to minimize the biases that have been identified in this type of study, such as lack of a baseline measurement of child’s anxiety and the use of supplemental nitrous oxide [8]
We attempted to control for the type of dental procedure to be performed and limit the children’s age range, among other variables
Summary
Uncooperative children may need to receive dental treatment under sedation, which is indicated when nonpharmacological behavior guidance is unsuccessful. Conscious sedation is a form of advanced behavior guidance technique, which is indicated for uncooperative or fearful/anxious children due to a lack of psychological, emotional or mental maturity or a physical or medical disability [7]. This pharmacological approach aims to enhance the patient’s physical comfort and safety and to control anxiety and behavior, as well as to allow for the completion of the procedure [7]. We concluded that, for young children, it might be advisable to combine ketamine with midazolam to provide better results in pediatric dental sedation
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