Pre Injection Use of Cryoanesthesia Versus Topical Anesthetic Gel in Reducing Pain Perception During Palatal Injections
Condition: Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      The goal of this interventional study is to assess the effectiveness of pre-injection use of
      topical ice application in decreasing pain perception when administering greater palatine
      nerve block injections as compared to that of topical 20 % benzocaine anesthetic gel using
      Visual Analogue Scale (VAS) for subjective pain assessment and Sound, Eye, Motor (SEM) scale
      for objective pain assessment in adult patients.

      The main question it aims to answer are:

        1. Does topical cooling reduce pain as effectively as topical benzocaine during greater
           palatine nerve block injections?

        2. Is there any adverse reactions during and after application of topical ice and 20 %
           benzocaine gel?

        3. Is there any difference in patient acceptability to the use of either methods during the
           administration of greater palatine nerve block.

      A split mouth design was used where an anesthetic injection was administered in the left and
      right posterior palatal area. The same operator administered the injections so as to
      standardize the flow rate and delivery style. The method of intervention i.e topical ice or
      topical 20% benzocaine anesthetic gel was randomly allocated to the patient by lottery
      method. The participants received two palatal injections with an interval of two weeks
      between the appointments. The subjective pain response of the patients during greater
      palatine nerve block injection with pre-injection use of topical ice and topical anesthetic
      gel (20% benzocaine) was recorded using VAS scale. The objective pain response of the
      patients were recorded by a blinded single observer using SEM scale on the same day of the
      appointment.

      Technique of application of topical ice: A new pack of sterile cotton swabstick that was
      injected with 0.5ml commercially available bottled water and then freezed the day before the
      appointment. At the time of intervention the injection site was dried with gauge piece and
      the frozen cotton swab stick was held by its wooden part and the frozen cotton end was placed
      on the proposed anesthetic site (palatal mucosa just anterior to the greater palatine
      foramen) for 1 minute. With the frozen cotton swabstick in place, an injection of 0.5 mL of 2
      percent Lidocaine with 1:200,000 epinephrine was administered into the injection site via a
      27-gauge short needle.

      Technique of application of topical anesthetic gel: After the oral mucosa was dried with a
      gauze piece, application of 0.2 mL Benzocaine 20% gel was done with a sterile swab stick on
      the proposed anesthetic site (palatal mucosa just anterior to the greater palatine foramen)
      for a period of two minutes as shown in figure. With the cotton swabstick in place an
      injection of 0.5 mL of 2 percent Lidocaine with 1:200,000 epinephrine was administered into
      the injection site via a 27-gauge short needle.
    


Intervention name(s): Topical Benzocaine; Topical ice
Intervention type(s): Drug; Other
Intervention description(s): Benzocaine topical anesthetic gel will be used a pre-injection anesthetic on one half of the palate before giving greater palatine nerve block; For the other half of the palate topical ice would be used before greater palatine nerve block
Intervention MeSH terms: Benzocaine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Cross sectional comparative split mouth study
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research