Randomised clinical trial to test the efficacy, safety and cost-effectiveness of sedatives; masked, controlled, parallel design with three arms, phase 4.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
84
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
Dental School
Goiânia, Goiás, Brazil
Child's behavior measured by an observational scale
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. Satisfactory behavior means more than 60% of score 1 during the entire appointment.
Time frame: Participants will be followed for the duration of the dental session, an expected average of 40 minutes
Acceptance of sedative administration measured by an observational scale
Acceptance of the sedative administration, assessed by OSUBRS (Ohio State University Behavioral Rating Scale) minute by minute in digital videos recorded during the administration. Scores: 1 - quiet, 2 - cry with movement, 3 - movement without cry; 4 - struggling.
Time frame: Participants will be assessed for the duration of the sedative administration, an expected average of 3 minutes
Participants' stress according to salivary cortisol
Occurrence of stress during dental procedure, assessed by salivary cortisol in children, their accompanying parent and the dentist in charge; the ELISA test will determine changes in cortisol level during dental treatment
Time frame: Change from baseline in the salivary cortisol at an expected average of 40 minutes
Pain measured by the FLACC Pain Assessment Tool
Occurrence of pain and associated changes in body expressions with potentially painful stimuli in children sedated for dental care
Time frame: Participants will be followed in video files for the duration of the dental session, an expected average of 40 minutes
Caregivers' and dentists' perceptions on sedation measured by a Visual Analogue Scale
Perception of caregivers and dentists on sedation, through self-report
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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
Time frame: During and soon after the dental session
Child's perceptions on sedation through a semi-structured interview
Child's perception concerning the dental treatment under sedation
Time frame: One week after the dental session
Memory of the dental procedure at the immediate post-operative period measured by a validated test
Memory of the dental procedure, according to test with figures validated in Brazil. Amnesia will be reported if children do not recall the figures showed after sedative administration
Time frame: Participants will be assessed for the recall of the dental procedure, at a time point of 20 minutes (average) after the end of the dental procedure
Memory of the dental procedure after 24 hours measured by a validated test
Memory of the dental procedure, according to test with figures validated in Brazil. Amnesia will be reported if children do not recall the figures showed after sedative administration
Time frame: Participants will be assessed for the recall of the dental procedure, at a time point of 24 hours (average) after the end of the dental procedure
Adverse events during the dental procedure
Occurrence of adverse events assessed by the World SIVA tool; adverse events will be categorised into minor, sentinel and major
Time frame: Participants will be followed for the duration of the dental session, an expected average of 40 minutes
Post-operative adverse events
Occurrence of adverse events while child is in the recovery room and after discharge, assessed by the World SIVA tool; adverse events will be categorised into minor, sentinel and major
Time frame: 24 hours
Cost analysis
Cost-effectiveness of different sedation protocols according to the methodology of health technologies assessment; the cost of each intervention will be compared
Time frame: One year and a half