Emla Cream Versus Benzocaine on Analgesia

NCT ID: NCT05060913

Last Updated: 2022-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-17
• Study Completion Date: 2022-03-04

Brief Summary

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.

Detailed Description

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.

Conditions

Effect of Drug

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

5% EMLA Cream

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

Group Type: EXPERIMENTAL

EMLA Cream

Intervention Type: DRUG

Effect of 5% Emla cream on pricking pain measured on VAS scale.

20% Benzocaine gel

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

Group Type: ACTIVE_COMPARATOR

Benzocaine Gel

Intervention Type: DRUG

Effect of 20% Benzocaine gel on pricking pain measured on VAS scale.

Interventions

EMLA Cream

Effect of 5% Emla cream on pricking pain measured on VAS scale.

Intervention Type: DRUG

Benzocaine Gel

Effect of 20% Benzocaine gel on pricking pain measured on VAS scale.

Intervention Type: DRUG

Other Intervention Names

2.5% Lidocaine and 2.5% Prilocaine; 20% Benzocaine

Eligibility Criteria

Inclusion Criteria

1. Patients indicated for bilateral extraction and requiring local anesthesia technique.

2. Patients in the age group of 18 to 35 years.

3. Patients willing to take part in study.

Exclusion Criteria

1. Patients not willing to participate in the study

2. Patients presenting with local inflammation / tenderness at site of injection

3. Patients who are allergic to local anesthesia

4. Patients on antidepressant or anti-psychotic drugs

5. Patient with history of any medical condition.

6. Patient with history of methemoglobinemia

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dow University of Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Shaharyar Hamid

Dr. Shaharyar Hamid

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shaharyar hamid

Role: PRINCIPAL_INVESTIGATOR

Dow University of Health Sciences

Locations

Dr. Ishrat-ul-Ebad institute of oral health sciences

Karachi, Sindh, Pakistan

Countries

Pakistan

Other Identifiers

ShHamid2190

Identifier Type: -

Identifier Source: org_study_id