Emla Cream Versus Benzocaine on Analgesia
Condition: Effect of Drug
Study type: Interventional
Phase: Early Phase 1

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.
    

Intervention name(s): EMLA Cream; Benzocaine Gel
Intervention type(s): Drug; Drug
Intervention description(s): Effect of 5% Emla cream on pricking pain measured on VAS scale.; Effect of 20% Benzocaine gel on pricking pain measured on VAS scale.
Other intervention name(s): 2.5% Lidocaine and 2.5% Prilocaine; 20% Benzocaine
Intervention MeSH terms: Lidocaine; Prilocaine; Benzocaine; Lidocaine, Prilocaine Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment