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临床试验/NCT05060913
NCT05060913已完成早期 1 期

Upshots of 5% Emla Cream Versus 20% Benzocaine on Pre-Injection Analgesia.

Dow University of Health Sciences1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2021年11月17日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
已完成
入组人数
70
试验地点
1
主要终点
Achievement of local anesthesia

研究概览

简要总结

EMLA is proven to be better in achieving pain control as topical anesthesia than benzocaine at palatal mucosa. So this research is done to compare its effectiveness at buccal mucosa.

Methods:

A total number of 70 patients attending DOW ojha hospital, fulfilling inclusion criteria and undergoing extraction of bilateral teeth will be included in this study. Approval of data collection will be sought from the Institutional ethical review board ¬(IERB) of Dow university of health sciences (DUHS) for this study. the participants will be briefed about the nature and purpose of the study including visual analogue scale (VAS). They will be ensured that their information will be used for the study purpose only. Informed consent from the participants will be obtained. Complete history from patients will be taken. The sites will be divided into condition A- 5% EMLA and Condition B - 20% Benzocaine Gel. After marking injection sites, principal investigator will leave the room and the consultant will apply 5% EMLA gel at experimental area and 20% Benzocaine gel at control area. After pre-treatment with topical anesthesia the consultant will administer local anesthesia to both sides. Then Principal investigator will be signaled into the room and patient will be assessed though visual analogue scale by him and will be confirmed by supervisor.

详细描述

The concept of dental pain is a true fear for many people. In dentistry, management of pain and anxiety has evolved through behavior modification and oral and intravenous sedatives. Whereas local anesthesia is known as the backbone of the profession. Over the years, methods have been introduced to reduce the pricking pain of local anesthesia injection. There are so many factors which help reduce the pain caused by local anesthesia injection such as warming the local anesthetic agent, specific size of needle gauge, a certain type of anesthetic solution and topical anesthetics. Topical anesthetics are used at insertion sites before injections to reduces the slight discomfort with insertion of the needle. [1,2,3] OneaofatheaTopicalaanesthetics widelyaused for dental proceduresaincludesaBenzocaine.[4] Benzocaine is anaFDA-approved drugawhichaisaavailable in various forms and concentrations. In the 20% concentration, benzocaineagel is the most commonly used topical anesthetic in dentistry, withaanaonsetatimeaofa30asecondsaandadurationaofa5-15aminutes. EMLA is a eutectic mixture of the two local anesthetics, prilocaine and lidocaine which melt at lower temperatures than any of its components, permitting higher concentrations of anesthetics for use.[5] It is used to reduce the pain associated with venous cannulation.

Past studies have reported the pharmacologic and the psychological effects on pain control by benzocaine and Eutectic mixture of local anesthetics (EMLA). However, there is no valuable data on the effect of the simultaneous use 5% EMLA and 20% Benzocaineaonapainaperceptionaduring injectionainaoralamucosaainapopulationaof Karachi. The presentastudyawasadesignedato evaluate the effect of topical application of 5% EMLAaand 20% Benzocaine in an adult population in reducing pain of injection of the local anesthetic agent.

Methods:

A total number of 70 patients attending DOW ojha hospital, fulfilling inclusion criteria and undergoing extraction of bilateral teeth will be included in this study. Approval of data collection will be sought from the Institutional ethical review board ¬(IERB) of Dow university of health sciences (DUHS) for this study. the participants will be briefed about the nature and purpose of the study including visual analogue scale (VAS). They will be ensured that their information will be used for the study purpose only. Informed consent from the participants will be obtained. Complete history from patients will be taken. The sites will be divided into condition A- 5% EMLA and Condition B - 20% Benzocaine Gel. After marking injection sites, principal investigator will leave the room and the consultant will apply 5% EMLA gel at experimental area and 20% Benzocaine gel at control area. After pre-treatment with topical anesthesia the consultant will administer local anesthesia to both sides. Then Principal investigator will be signaled into the room and patient will be assessed though visual analogue scale by him and will be confirmed by supervisor.

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
None

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients indicated for bilateral extraction and requiring local anesthesia technique.
  • Patients in the age group of 18 to 35 years.
  • Patients willing to take part in study.

排除标准

  • Patients not willing to participate in the study
  • Patients presenting with local inflammation / tenderness at site of injection
  • Patients who are allergic to local anesthesia
  • Patients on antidepressant or anti-psychotic drugs
  • Patient with history of any medical condition.
  • Patient with history of methemoglobinemia

研究组 & 干预措施

5% EMLA Cream

Experimental

EMLA cream will be applied over buccal mucosa of one side for 1.5 minutes of Maxillary of Mandibular anterior teeth.

干预措施: EMLA Cream (Drug)

20% Benzocaine gel

Active Comparator

Benzocaine gel will be applied over buccal mucosa on another side for 1.5 minutes of Maxillary of Mandibular anterior teeth.

干预措施: Benzocaine Gel (Drug)

结局指标

主要结局

Achievement of local anesthesia

时间窗: Reading on VAS will be taken after applying Benzocaine gel for 1.5 minutes.

local anesthesia will be assessed with the help of Visual Analog Scale. VAS score must be '0' while pricking injection for applying Local anesthesia.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shaharyar Hamid

Dr. Shaharyar Hamid

Dow University of Health Sciences

研究点 (1)

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