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临床试验/CTRI/2018/04/013424
CTRI/2018/04/013424尚未招募不适用

Comparison of pain perception in child patients during IANB using local anaesthetic solution at room temperature and 42°C.

Government1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年4月25日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Patient May Feel Less Pain During Local Anesthesia administration At 42°C

研究概览

简要总结

Local anaesthetic cause pain during administration into soft tissue and this leads to stress and discomfort especially in child patients. This pain can be reduced easily and effectively by heating the local anaesthetic solution up to body temperature or above.Warming lidocaine causes no chemical denaturation or no diminished stability stated by one lidocaine manufacturer (Elkins-Sinn, Inc, Cherry Hill, NJ). This method reduces burning sensation in orthography, angiography and other interventional procedures by warming lidocaine to 43°C before infiltrative injection. We are planning to use this method to reduce discomfort during nerve block in pediatric dental patients.

This study will  include 60 child patients of age 6-10 years in which pain perception will be  evaluated during Inferior alveolar nerve block using warm local anaesthetic at 42°C. During first visit  the children will receive IANB block consisting of  lidocaine 2% and epinephrine 1:2,00,000 at room temperature. At the second visit, the contralateral side will receive local anaesthetic warmed at 42°C.  15 cm long visual analogue scale will be used to determine the pain from injection given.

We are hopeful that this method will work on pediatric dental setting also.

研究设计

研究类型
Interventional
分配方式
Other
盲法
Participant and Investigator Blinded

入排标准

年龄范围
6.00 Year(s) 至 10.00 Year(s)(—)
性别
All

入选标准

  • •Healthy child patients requiring routine dental treatment especially without known history of hypersensitivity to local anaesthetic lidocaine.
  • •patients that need bilateral pulpotomy or extraction of teeth in mandibular molars requiring local anaesthetics (LA) with 2% lidocaine with 1: 2,00,000 epinephrine.

排除标准

  • •patients having systemic ailment.
  • •Patients having known allergy to Local anesthetic lidocain.
  • •patients who does not require local anesthetic for treatment.

结局指标

主要结局

Patient May Feel Less Pain During Local Anesthesia administration At 42°C

时间窗: 2 minutes

次要结局

  • Injection fear may reduce in child patients(5 minutes)

研究者

发起方
Government
申办方类型
Other [Government Dental College ]

研究点 (1)

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