Pain and Anxiety Evaluation in Children Using Different Techniques of Local Anesthesia for Dental Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Self-perception of pain
研究概览
简要总结
Fear and dental anxiety are often associated with the use of needles and syringes for local anesthesia, and painful perception during the administration of local anesthetics is often the main reason for anxiety behaviors and defensive reactions. Dental trauma originates in childhood, through experience misconduct. The objective of this study is to evaluate the pain and anxiety related to 4 different modalities of anesthesia in children. Will be selected volunteers aged between 5 and 12 years who need restorative dental treatment in posterior teeth in the upper 2 quadrants. All patients will receive 1 modality of anesthesia: conventional anesthesia (control group), computerized anesthesia, Dental Vibe anesthesia and computerized anesthesia + DentalVibe anesthesia. Evaluations will be made with physiological and behavioral criteria. For the physiological evaluation will be measured the blood pressure, respiratory rate, heart rate, oximetry and salivary cortisol before and during each anesthesia. As criteria for evaluation of anxiety will be applied the methods, Corah and modified VPT before anesthesia and modified VPT will be repeated after anesthesia. The pain will be assessed at the end of each anesthesia with Visual Analogue Scale (VAS) and Wong Baker Faces. The results will be submitted to parametric and non-parametric statistical analysis, according to the data obtained in the different evaluation criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 5 Years 至 12 Years(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children of both sexes, aged between 5 and 12 years, requiring dental treatment under local anesthesia in the first permanent molars or deciduous maxilla.
排除标准
- •The person responsible does not authorize the participation of the child as a research volunteer.
- •Be using pain modulating drugs.
- •Be using anxiety modulating drugs.
- •Patients with a history of hypersensitivity to local anesthetics.
- •Patients with a history of systemic diseases.
研究组 & 干预措施
Control Group
The children anesthesia will be traditional technique
干预措施: Local anesthesia with traditional technique (Device)
DentalVibe Group
The children anesthesia will be DentalVibe technique
干预措施: Topic anesthesia (Drug)
Control Group
The children anesthesia will be traditional technique
干预措施: Topic anesthesia (Drug)
Control Group
The children anesthesia will be traditional technique
干预措施: Local anesthetic (Drug)
Computerized Group
The children anesthesia will be computerized technique
干预措施: Local anesthesia with computerized technique (Device)
Computerized Group
The children anesthesia will be computerized technique
干预措施: Topic anesthesia (Drug)
Computerized Group
The children anesthesia will be computerized technique
干预措施: Local anesthetic (Drug)
DentalVibe Group
The children anesthesia will be DentalVibe technique
干预措施: Local anesthesia with DentalVibe technique (Device)
DentalVibe Group
The children anesthesia will be DentalVibe technique
干预措施: Local anesthetic (Drug)
结局指标
主要结局
Self-perception of pain
时间窗: Immediately after anesthesia
The pain will be analyzed by the Visual Analogue Scale (0-10). 0- no pain, 10- severe pain
Pain Behavior
时间窗: During the anesthetic procedure
The pain will be analyzed by the FLACC
次要结局
- SCARED Questionnaire(Before anesthesia)
- Corah Questionnaire(Before anethesia)
- VPT modified(Before anethesia and immediately after anesthesia)
- Blood pressure(Immediately before anesthesia, during anesthesia)
- Respiratory rate(Immediately before anesthesia, during anesthesia)
- Heart rate(Immediately before anesthesia, during anesthesia)
- Oxygen saturation(Immediately before anesthesia, during anesthesia)
- Salivary cortisol(Immediately before anesthesia, during anesthesia)
研究者
Priscila de Camargo Smolarek
PhD student
Universidade Estadual de Ponta Grossa
