Evaluation of Post-operative Discomforts in Children After Extraction of Temporary Teeth _ DEXTRAFANT _ RC16_0183
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- prevalence and severity of pain after extraction of deciduous teeth
研究概览
简要总结
This prospective observational study aim to evaluate discomforts after extraction of temporary tooth under local anesthesia. The first objective is to describe the prevalence of the post-extraction pain (PEP), post-extraction bleeding (PEB), post-extraction biting injury (PEBI) in children, and the analgesic usage. The secondary objective is to define whether it is possible to determine a profile of patients or a type of extraction's procedure predictive to PEP and administration of analgesics, PEB or PEBI.
详细描述
125 children in range of 2-15 years indicated for tooth extractions will be included in this study.
Informed consent will be obtained from all individual participants included in this study.
Immediately after extraction and until the following day, parents will be asked to assess the post-operative discomforts and to administrate paracetamol (acetaminophen) as soon as the child expressed a pain score ≥2 evaluated on the faces pain scale-revised (FPS-R).
A structured form is designed to obtained information regarding the patient's age, gender, socioeconomic level, and cooperation of the child before and during anesthesia or extraction, influence of accompanying person, number of previous extraction, dental hygiene. Moreover, details about the type of extraction; the indication of extraction (tooth decay, orthodontic treatment, obstacle, infection and traumatism), the type of tooth (incisor-canine or molar), the degree of root resorption, number of doses of local anesthetic, and presence of preexisting or per-operative pain are also collected.
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
- 2 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children in range of 2-15 years indicated for tooth extractions under local anesthesia.
排除标准
- •patient under analgesic the day of the appointment or under non steroidal anti-inflammatory agents through 8 days before the extraction;
- •contraindication to paracetamol/acetaminophen;
- •incomplete mental health;
- •extraction under sedation (including nitrous oxide/oxygen) and under general anesthesia.
- •extractions of permanent tooth;
- •Child was also excluded from the study if parents could not be reached by phone within 32 hours after extraction and if the parents don't speak French.
结局指标
主要结局
prevalence and severity of pain after extraction of deciduous teeth
时间窗: 32 hours post-operatively
pain evaluated on the EVA faces pain scale-revised
次要结局
- Determination of a profile of a type of extraction's procedure predictive to PEP and administration of analgesics, PEB or PEBI(Day 1)
- Determination of a profile of patients predictive to PEP and administration of analgesics, PEB or PEBI(Day 1)