Articaine 4% Efficacy and Safety in Extraction and Pulpotomy of Primary Molars of Children Below the Age of Four Years.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 292
- 主要终点
- Behavior
研究概览
简要总结
compare the anaesthetic efficacy and safety for pain and behaviour for extraction or pulp therapy in primary molars in young children below four years old using 4% articaine and 2% lidocaine local anesthetics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy children
- •3-6 years
- •primary molar indicated for pulpotomy
- •body weight not less than 15 Kg
排除标准
- •Intellectual problem
- •sever emotional problems
- •previous dental experience
- •Medically or mentally compromised children
研究组 & 干预措施
Lidocaine
Lidocain hydrochloride 2 %with epinephrine 1:100000
干预措施: Lidocain hydrochloride 2 % with epinephrine (Drug)
Articaine
Articaine chloride 4% with epinephrine 1:100000
干预措施: Articaine chloride 4% with epinephrine (Drug)
结局指标
主要结局
Behavior
时间窗: 30-60 minutes
Evaluate child behavior using frankl scale during treatment
Blood pressure
时间窗: 30-60 minutes
Vital signs
Heart rate
时间窗: 30-60 minutes
Vital signs
Intra and post operative pain
时间窗: 30-60 minutes
Evaluate pain during injection and treatment using FLACC (face,legs,activity, cry, consolabolity) scale
Respiratory rate measuring during treatment
时间窗: 30-60 minutes
Vital signs
次要结局
未报告次要终点
研究者
Mahmoud Ahmed Mahmoud
Lecturer
Minia University