Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05060913
Other study ID # ShHamid2190
Secondary ID
Status Completed
Phase Early Phase 1
First received
Last updated
Start date November 17, 2021
Est. completion date March 4, 2022

Study information

Verified date July 2022
Source Dow University of Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date March 4, 2022
Est. primary completion date March 2, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
EMLA Cream
Effect of 5% Emla cream on pricking pain measured on VAS scale.
Benzocaine Gel
Effect of 20% Benzocaine gel on pricking pain measured on VAS scale.

Locations

Country Name City State
Pakistan Dr. Ishrat-ul-Ebad institute of oral health sciences Karachi Sindh

Sponsors (1)

Lead Sponsor Collaborator
Dow University of Health Sciences

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Primary 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.
See also
  Status Clinical Trial Phase
Not yet recruiting NCT04549012 - Determination of Blood Loss After CS Early Phase 1
Active, not recruiting NCT06114758 - Comparison Effectiveness of Rectal Misoprostol & Intravenous Tranexamic Acid Reducing Hemorrhage in Myomectomy
Completed NCT05076253 - Efficacy of Ivermectin in COVID-19 Phase 1/Phase 2
Recruiting NCT04573049 - The Effectiveness and Safety of Levosimendan in Patients With Severe Aortic Stenosis and Heart Failure Undergoing Transcatheter Aortic Valve Replacement Phase 4
Not yet recruiting NCT04562493 - Comparative Effect of Transforaminal Injection of Magnesium Sulphate Versus Ozone Therapy on Oxidative Stress Biomarkers in Lumbar Disc Related Radicular Pain N/A
Completed NCT04762147 - Comparison of Perioperative Analgesia Between Intravenous Paracetamol and Fentanyl for Rigid Hysteroscopy Phase 3
Completed NCT06432309 - Opicapone as Adjunctive Therapy to Levodopa-Carbidopa Intestinal Gel in Parkinson's Disease N/A
Not yet recruiting NCT05510986 - The Effect of Oxycodone Hydrochloride on CRBD After TURBT Under General Anesthesia N/A
Recruiting NCT05968885 - Evaluation the Efficacy Between Botox Injection and Combination Pharmacotherapy in Patients With Detrusor Overactivity Phase 4
Recruiting NCT05092074 - Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX) for Patients With Hepatitis C Virus Infection
Recruiting NCT05595044 - Effect of Vitamin D Therapy in Autism Spectrum Disorder Phase 1
Not yet recruiting NCT06100510 - PFA 100 Evaluation and Reference Interval HOACNY Phase 4
Not yet recruiting NCT05293119 - Role of Tofacitinib in Vitiligo Patients Early Phase 1
Not yet recruiting NCT06414018 - Effect of Equivalent Dose Sufentanil and Afentanil in Bronchoscopic Treatment N/A
Recruiting NCT05786859 - The Efficacy and Safety of Rifaximin Treatment Early Phase 1
Not yet recruiting NCT06290219 - The Effect of Platelet-rich Plasma Nasal Injection in the Treatment of Traumatic Olfactory Dysfunction Phase 3
Completed NCT05277480 - Apatinib With Ifosfamide Plus Etoposide for Relapsed or Refractory Osteosarcoma (OAIE) Phase 2
Recruiting NCT05482451 - Nivolumab and All-trans Retinoic Acid for Pancreatic Cancer Early Phase 1
Not yet recruiting NCT04892212 - Sirolimus in Treatment of Proteinuric Flares of Lupus Nephritis Phase 2/Phase 3
Not yet recruiting NCT05918146 - Dextrose Therapy on Physical Therapy in Subdeltoid Bursitis Phase 4