The Effect of Needle-free Injection System Versus Traditional Anesthesia on Pain Perception During Palatal Infiltration Anesthesia in Children: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Wong-Baker Faces Pain Rating Scale (PRS)
研究概览
简要总结
Needle-free injection systems can contribute to the prevention of needle-related pain during palatal infiltration anesthesia (PIA) in children. Research with this topic on children is required.The purpose of this clinical study was to evaluate the effectiveness of the needle-free system versus traditional anesthesia on pain perception during PIA in children.The study was designed as a randomized, controlled cross-over clinical study with 48 children aged 6 to 12 years requiring dental treatment with PIA in bilateral maxillary primary molars. It has been revealed that the application of a needle-free system during PIA ensured a decrease in pain perception in children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •In need of treatment of right and left primary molar teeth of maxilla,
- •Does not have any systemic disorder,
- •High level of communication that can provide logical answers to the questions we ask
- •With parental consent,
- •Volunteers who want to participate in the research
- •6-12 years old patients who are compatible with routine dental treatments in the pediatric clinic
排除标准
- •No need for treatment of right and left primary molar teeth of maxilla,
- •Has a systemic condition
- •Low level of communication that cannot provide reasonable answers to the questions we ask
- •Without parental consent
- •Do not want to participate voluntarily in the research
- •Do not attend a check-in
- •Patients not in the 6-12 age group
结局指标
主要结局
Wong-Baker Faces Pain Rating Scale (PRS)
时间窗: 3 months
The PRS measures the unpleasantness or affective dimension of a child's pain experience and is used in children aged 3-17 years old. The PRS consists of a set of cartoon faces with varying facial expressions ranging from a smile/laughter to tears, and each child is asked to select the facial expression that best represents his/her experience of discomfort. Each face has a numerical value ranging from 0 (smiling face, "no hurt") to 5 (crying/screaming face, "hurts worst").
Face, Legg, Cry, Consolability Scale (FLACC)
时间窗: 3 months
The scale comprised the following parameters: (1) Face, (2) Legs, (3) Activity, (4) Cry, and (5) Consolability. Each of the five categories is scored from 0-2, which results in a minimum total score of 0 and maximumof 10. According to this scale: 0=Relaxed and comfortable (no pain); 1-3=Mild discomfort; 4-6=Moderate pain; and 7-10=Severe discomfort or pain \[Willis et al., 2003\]. Behavioural parameters were recorded.
次要结局
未报告次要终点
研究者
Emine Kaya
Principal Investigator
Okan University