Efficacy, Safety and Cost-effectiveness of Intranasal Sedation With Ketamine and Midazolam in Pediatric Dentistry: a Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Child's behavior measured by an observational scale
研究概览
简要总结
Randomised clinical trial to test the efficacy, safety and cost-effectiveness of sedatives; masked, controlled, parallel design with three arms, phase 4.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •American Society of Anesthesiologists I (healthy) or II (mild and controlled systemic disease such as persistent asthma)
- •Small risk of airway obstruction (Mallampati less than 2 or tonsillar hypertrophy occupying less than 50% of the oropharynx)
- •No medical history of neurological or cognitive changes
- •Absence of facial deformities
- •Term birth
- •No use of drugs that may impair cognitive functions
- •At least two teeth with cavities without pulp involvement, requiring dental restoration under local anesthesia and rubber dam
排除标准
- •Positive or definitely positive behavior (Frankl et al, 1962) in a dental treatment session conducted by the research team
研究组 & 干预措施
Experimental
Intranasal administration of ketamine (4.0 mg/kg, max. 100 mg) and midazolam (0.2 mg/kg, max. 5 mg)
干预措施: Intranasal ketamine (Drug)
Experimental
Intranasal administration of ketamine (4.0 mg/kg, max. 100 mg) and midazolam (0.2 mg/kg, max. 5 mg)
干预措施: Intranasal midazolam (Drug)
Comparator
Oral administration of ketamine (4.0 mg/kg, max. 100 mg) and midazolam (0.5 mg/kg, max. 20 mg)
干预措施: Oral ketamine (Drug)
Comparator
Oral administration of ketamine (4.0 mg/kg, max. 100 mg) and midazolam (0.5 mg/kg, max. 20 mg)
干预措施: Oral midazolam (Drug)
Control
Oral administration of midazolam (1.0 mg/kg, max. 20 mg)
干预措施: Oral midazolam (Drug)
结局指标
主要结局
Child's behavior measured by an observational scale
时间窗: Participants will be followed for the duration of the dental session, an expected average of 40 minutes
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.
次要结局
- Cost analysis(One year and a half)
- Acceptance of sedative administration measured by an observational scale(Participants will be assessed for the duration of the sedative administration, an expected average of 3 minutes)
- Participants' stress according to salivary cortisol(Change from baseline in the salivary cortisol at an expected average of 40 minutes)
- Pain measured by the FLACC Pain Assessment Tool(Participants will be followed in video files for the duration of the dental session, an expected average of 40 minutes)
- Memory of the dental procedure after 24 hours measured by a validated test(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(Participants will be followed for the duration of the dental session, an expected average of 40 minutes)
- Post-operative adverse events(24 hours)
- Memory of the dental procedure at the immediate post-operative period measured by a validated test(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)
- Caregivers' and dentists' perceptions on sedation measured by a Visual Analogue Scale(During and soon after the dental session)
- Child's perceptions on sedation through a semi-structured interview(One week after the dental session)
研究者
Luciane Ribeiro de Rezende Sucasas da Costa
Professor
Universidade Federal de Goias