A Study of the Role of Some Drug Delivery Systems in Enhancing the Efficiency of EMLA Cream in Palatal Anesthesia for Children Aged Between 7-11 Years Old
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Changes in the values of each of the heart rate and oxygen rate
研究概览
简要总结
The aim of this study is to Avoid traditional palatal local injections when extracting upper primary teeth through enhancing the efficiency of EMLA cream by using drug delivery systems (permeability enhancer (DMSO), oral patches and micro-needle patches) for palatine injection.
Group 1: Conventional local palatine injection (control group). Group 2: EMLA cream only. Group 3 :chemical permeability enhancer DMSO with EMLA cream. Group 4: Oral patches with EMLA Cream. Group 5: Micro-needle patches dissolved with EMLA Cream.
详细描述
The insertion of the needle and the infusion of the anesthetic solution into the palate often uncomfortable for the children and their acceptance of dental treatment. Therefore, there is a need for studies to find ways to replace the palatine injection in the modern dentistry.
Effectiveness of Compound surfactant drugs (EMLA) have strong activity on the palatine tissues. Therefore, it will be chosen as an alternative to the traditional ones and will be enhanced by one of the drug delivery systems (physical/chemical).
Decreased permeability of the palatine mucosa is a major reason behind using drug delivery systems to reach an effective therapeutic level.
To our knowledge, this research will be the first which will be used a method of drug delivery systems to replace traditional palatal needle.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •no previous dental experience.
- •Healthy children.
- •Definitely positive or positive ratings of Frank scale
- •Child did not receive any sedative or pain drugs during the last three.
- •Presence of upper primary teeth, an indication for extraction
排除标准
- •Presence of general diseases or health problems.
- •Uncooperative children
- •Children with congenital or idiopathic Methemoglobin
- •Teeth with severe abscesses
研究组 & 干预措施
Conventional local palatine injection
Conventional palatal injection with anesthetic (lidocaine 2% with Epinephrine 1:80000, Korea) will be performed and the following measures (face expressions ( Wong-Baker Faces) heart rate and oxygen rate and FLACC pain scale) will be recorded to determine the reaction of the child.
干预措施: Conventional local palatine injection (Other)
EMLA cream only
The palatine mucosa will be dried with a cotton ball 2*2 and then 0,2 g of Emla cream will be applied for 3 minutes . During this period and the following measures (face expressions ( Wong-Baker Faces) heart rate and oxygen rate and FLACC pain scale) will be recorded to determine the reaction of the child.
干预措施: EMLA cream only (Drug)
chemical permeability enhancer DMSO with EMLA cream
The palatine mucosa will be dried with a cotton ball and then EMLA cream will be mixed with a permeability enhancer in the laboratory of pharmaceutical industries at the Faculty of Pharmacy at Damascus University according to the following: Adding 10 g of EMLA cream 5%, 1,026 g of DMSO 100% and it will be applied with cotton bud for a period of 3 minutes. During this period and the following measures (face expressions ( Wong-Baker Faces) heart rate and oxygen rate and FLACC pain scale) will be recorded to determine the reaction of the child.
干预措施: chemical permeability enhancer DMSO with EMLA cream (Drug)
Oral patches with EMLA Cream
The palatine mucosa will be dried with a cotton ball and then 0.2 g of EMLA cream 5% will be applied by using an oral patch 14*14 mm for 3 minutes. During this period and the following measures (face expressions ( Wong-Baker Faces) heart rate and oxygen rate and FLACC pain scale) will be recorded to determine the reaction of the child.
干预措施: Oral patches with EMLA Cream (Drug)
Micro-needle patches dissolved with EMLA Cream
The palatine mucosa will be dried with a cotton ball 2*2 and then 0.2 g of EMLA cream 5% will be applied by using an micro-needle patch 14*14 mm, 0,25 micron for 3 minutes.
干预措施: Micro-needle patches dissolved with EMLA Cream (Drug)
结局指标
主要结局
Changes in the values of each of the heart rate and oxygen rate
时间窗: On application of the substance
The heart and oxygen rate will be recorded by pulse oximeter
Evaluation conventional local palatine injection
时间窗: On extraction
The heart and oxygen rate will be recorded by pulse oximeter
Pain levels using self-reported Wong-Baker faces pain scale
时间窗: On extraction
0= "no hurt", 2= "hurts a little bit", 4="hurts a little more", 6= "hurts even more", 8= "hurts a whole lot", 10= "hurts worst"
Pain levels using FLACC scale
时间窗: On extraction
0 = Relaxed and comfortable, 1-3 = Mild discomfort, 4-6 =Moderate pain, 7-10 = Severe discomfort/pain
次要结局
未报告次要终点