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临床试验/NCT03176446
NCT03176446已完成不适用

Pain and Anxiety Evaluation in Children Using Different Techniques of Local Anesthesia for Dental Treatment

Universidade Estadual de Ponta Grossa1 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2017年10月1日最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

The children anesthesia will be traditional technique

干预措施: Local anesthesia with traditional technique (Device)

DentalVibe Group

Active Comparator

The children anesthesia will be DentalVibe technique

干预措施: Topic anesthesia (Drug)

Control Group

Active Comparator

The children anesthesia will be traditional technique

干预措施: Topic anesthesia (Drug)

Control Group

Active Comparator

The children anesthesia will be traditional technique

干预措施: Local anesthetic (Drug)

Computerized Group

Active Comparator

The children anesthesia will be computerized technique

干预措施: Local anesthesia with computerized technique (Device)

Computerized Group

Active Comparator

The children anesthesia will be computerized technique

干预措施: Topic anesthesia (Drug)

Computerized Group

Active Comparator

The children anesthesia will be computerized technique

干预措施: Local anesthetic (Drug)

DentalVibe Group

Active Comparator

The children anesthesia will be DentalVibe technique

干预措施: Local anesthesia with DentalVibe technique (Device)

DentalVibe Group

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Priscila de Camargo Smolarek

PhD student

Universidade Estadual de Ponta Grossa

研究点 (1)

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