Adverse Event Risk Assessment in the Use of Nitrous Oxide for Pediatric Dental Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 364
- 试验地点
- 1
- 主要终点
- occurrence of vomiting
研究概览
简要总结
The objective was to assess adverse event risk in the use of Nitrous Oxide for Pediatric Dental Patients. The investigators performed a multicenter observational study. The investigators included patients aged 1 to 18 years and who have already failed dental care because of non-cooperation; they could be with mental or cognitive disabilities and could have sedative premedication. The investigators performed any type of dental care With the Use of Nitrous Oxide/Oxygen Sedation. The primary outcome was vomiting assessed during or after dental care.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients under 18 years
- •Use of nitrous oxide/oxygen analgesia/anxiolysis
- •Any type of dental care
排除标准
- •Use of midazolam
- •Use of general anesthesia
结局指标
主要结局
occurrence of vomiting
时间窗: from the beginning of Nitrous Oxide/Oxygen administration up to half an hour after the end of dental treatment
次要结局
未报告次要终点
研究者
Frederic COURSON
PhD, DDS
Assistance Publique - Hôpitaux de Paris