Emla Cream Versus Benzocaine on Analgesia

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

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.

Study Overview

• Status: Completed
• Conditions: Effect of Drug
• Intervention / Treatment: Drug: EMLA Cream; Drug: Benzocaine Gel

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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 775500
      • Dr. Ishrat-ul-Ebad institute of oral health sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 5% EMLA Cream; EMLA cream will be applied over buccal mucosa of one side for 1.5 minutes of Maxillary of Mandibular anterior teeth.	Drug: EMLA Cream; Effect of 5% Emla cream on pricking pain measured on VAS scale.; Other Names: 2.5% Lidocaine and 2.5% Prilocaine
Active Comparator: 20% Benzocaine gel; Benzocaine gel will be applied over buccal mucosa on another side for 1.5 minutes of Maxillary of Mandibular anterior teeth.	Drug: Benzocaine Gel; Effect of 20% Benzocaine gel on pricking pain measured on VAS scale.; Other Names: 20% Benzocaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Achievement of local anesthesia	local anesthesia will be assessed with the help of Visual Analog Scale. VAS score must be '0' while pricking injection for applying Local anesthesia.	Reading on VAS will be taken after applying EMLA cream for 1.5 minutes.
Achievement of local anesthesia	local anesthesia will be assessed with the help of Visual Analog Scale. VAS score must be '0' while pricking injection for applying Local anesthesia.	Reading on VAS will be taken after applying Benzocaine gel for 1.5 minutes.

Collaborators and Investigators

• Sponsor: Dow University of Health Sciences
• Investigators: Principal Investigator: Shaharyar hamid, Dow University of Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2021
• Primary Completion (Actual): March 2, 2022
• Study Completion (Actual): March 4, 2022

Study Registration Dates

• First Submitted: September 18, 2021
• First Submitted That Met QC Criteria: September 18, 2021
• First Posted (Actual): September 29, 2021

Study Record Updates

• Last Update Posted (Actual): July 29, 2022
• Last Update Submitted That Met QC Criteria: July 27, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Anesthetics, Combined; Lidocaine; Prilocaine; Lidocaine, Prilocaine Drug Combination; Benzocaine
• Other Study ID Numbers: ShHamid2190

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No