Midazolam and Ketamine Effect Administered Through the Nose for Sedation of Children for Dental Treatment
Condition: Child Behavior; Dental Caries
MeSH terms: Dental Caries
Study type: Interventional
Phase: Phase 4

Summary: 
      Randomised clinical trial to test the efficacy, safety and cost-effectiveness of sedatives;
      masked, controlled, parallel design with three arms, phase 4.
    

Detailed description: 
      About 10% of children may have behavioral problems during dental treatment, but the evidence
      for sedative protocols that benefit the care in pediatric dentistry are still weak. This
      randomized, masked, controlled, parallel design study aims to evaluate the efficacy, safety
      and cost-effectiveness of intranasal sedation with ketamine / midazolam in healthy children
      aged 2 to 6 years old. Children will be selected among those with dental decay that do not
      allow dental treatment to be performed, and need at least two restorations under local
      anesthesia and rubber dam isolation. It is estimated a preliminarily a sample of 84 children
      equally divided into three groups: A) Ketamine (4.0 mg / kg up to 100 mg) + midazolam (0.2 mg
      / kg, maximum 5 mg) intranasally; B) ketamine (4.0 mg / kg up to 100 mg) + midazolam (0.5 mg
      / kg, maximum 20 mg) orally; C) midazolam (1.0 mg / kg, maximum 20 mg) orally. The hypothesis
      is that ketamine / midazolam combination, administered intranasally, it constitutes an
      effective sedative regime, safe and cost-effective for use in pediatric dentistry in the
      public service. The primary endpoint is the behavior of the child. Secondary endpoints are:
      sedative administration acceptance, procedure memory and salivary cortisol levels within each
      intervention group. Additionally, we will evaluate: the occurrence of pain and associated
      changes in facial expressions with potentially painful stimuli in children sedated for dental
      care; caregivers and paediatric dentists' stress and perception about sedation; adverse
      events that occur during and after administration of sedatives; cost-effectiveness of the
      sedative protocols. The experimental design is planned to minimize systematic and random
      errors and to contribute to higher level of evidence in future systematic reviews. The
      outcomes of this study have potential impact on public and private health practice, and may
      support institutional guidelines dealing with this theme.
    

Intervention name(s): Intranasal ketamine; Oral ketamine; Intranasal midazolam; Oral midazolam
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Ketamine injectable solution in a concentration of 50.0 mg/mL administered into the nose with an atomizer; dose of 4.0 mg/kg, maximum 100.0 mg; Ketamine injectable solution in a concentration of 50.0 mg/mL via oral route; dose of 4.0 mg/kg maximum 100.0 mg; Midazolam injectable solution in a concentration of 5.0 mg/mL administered into the nose with an atomizer; dose of 0.2 mg/kg, maximum 5.0 mg; 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; dose of 1.0 mg/kg, maximum 20.0 mg when give as a solely agent
Other intervention name(s): Ketamin S, Cristalia, São Paulo, Brazil; Ketamin S, Cristalia, São Paulo, Brazil; Dormire injectable solution, Cristalia, São Paulo, Brazil; Dormire oral solution, Cristalia, São Paulo, Brazil
Intervention MeSH terms: Midazolam; Ketamine; Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dental caries; Moderate sedation