跳至主要内容
临床试验/NCT02886351
NCT02886351Unknown不适用

High-Concentration Nitrous Oxide for Dental Procedural Sedation in Children

Bnai Zion Medical Center0 个研究点目标入组 30 人开始时间: 2017年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
30
主要终点
Achieving cooperation in Pediatric dentistry numerical scale

研究概览

简要总结

The use of nitrous oxide as a sedative agent is very common in pediatric dentistry. In concentrations up to 50% it is considered as mild sedation and it is very safe. Despite its safety and widespread of its use nitrous oxide is not a potent drug and many times dentists fail to gain cooperation in moderate or high anxious children, and the alternatives are to use moderate sedation with drugs such as Midazolam, Atarax or general anesthesia. Higher concentration was not conducted in Pediatry densitery. The aim of this study is to compare the effectivity and safety of providing nitrous oxide at increasing concentrations 60%, 70% with 50% parameters, sedation depth, adverse events and cooperation of the child during the dental treatment.Our hypothesis is that nitrous oxide in concentrations higher than 50% up to 70% is a safe and effective sedation method in dental treatment of children.

详细描述

Nitrous oxide/oxygen in varying concentrations has been successfully used for many years to provide sedation and analgesia for a variety of painful procedures in children. The use of nitrous oxide as a sedative agent is very common in pediatric dentistry. In concentrations up to 50% it is considered as mild sedation and it is very safe. It is usually used for mild or moderate anxiety state because it is not so potent in concentrations up to 50 %. Despite its safety and widespread of its use nitrous oxide is not a potent drug and many times dentists fail to gain cooperation in moderate or high anxious children, and the alternatives are to use moderate sedation with drugs such as Midazolam, Atarax or general anesthesia. Nitrous oxide 50% is the most common concentration in use but the results of the sedation does not always provide a satisfactory cooperation, higher concentration was not conducted in Pediatry densitery. The aim of this study is to compare the effectivity and safety of providing nitrous oxide at increasing concentrations 60%, 70% with 50% parameters, sedation depth, adverse events and cooperation of the child during the dental treatment.Our hypothesis is that nitrous oxide in concentrations higher than 50% up to 70% is a safe and effective sedation method in dental treatment of children.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
3 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children evaluated by a senior pediatric dentist and require a wide treatment of caries, with a high score of anxiety unable to accept dental treatment with nitrous oxide /oxide of 50% in combined with behavioral management in the pediatric dental clinic.
  • Exclusion criteria:
  • Children with high potential risk of sedation, snoring, stridor, sleep apnea, maxillofacial malformation, history of airway difficulty, gastro esophageal reflux, reactive airway disease or acute runny nose, cardiac disease, altered mental status, inadequate fasting time.
  • Parental refusal for conscious sedation.

排除标准

  • 未提供

研究组 & 干预措施

nitrous oxide

Experimental

Administration of high concentration of nitrous oxygen in pediatric dentistry

干预措施: Nitrous Oxide (Drug)

结局指标

主要结局

Achieving cooperation in Pediatric dentistry numerical scale

时间窗: less than 60 minutes

次要结局

未报告次要终点

研究者

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

MOSTAFA.SOMRI

M.D.

Bnai Zion Medical Center

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