Emla Cream Versus Benzocaine on Analgesia

NCT05060913 | Completed Early Phase 1 DMC

• 1 other identifier: ShHamid2190
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Effect of Drug

Outcome Measures

Primary Outcomes (2)

• 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.

Study Arms (2)

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.

Drug: EMLA Cream

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.

Drug: Benzocaine Gel

Interventions

EMLA Cream DRUG

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

Also known as: 2.5% Lidocaine and 2.5% Prilocaine

5% EMLA Cream

Benzocaine Gel DRUG

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

Also known as: 20% Benzocaine

20% Benzocaine gel

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Dow University of Health Sciences: lead

Study Sites (1)

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

Karachi, Sindh, 775500, Pakistan

Location

MeSH Terms

Interventions

Lidocaine, Prilocaine Drug Combination; Lidocaine; Prilocaine; Benzocaine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Drug Combinations; Pharmaceutical Preparations; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Shaharyar hamid

  Dow University of Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Shaharyar Hamid

Study Record Dates

• First Submitted: September 18, 2021
• First Posted: September 29, 2021
• Study Start: November 17, 2021
• Primary Completion: March 2, 2022
• Study Completion: March 4, 2022
• Last Updated: July 29, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)