Pre Injection Use of Cryoanesthesia Versus Topical Anesthetic Gel in Reducing Pain Perception During Palatal Injections

Study Overview
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Brief Summary
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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: Does topical cooling reduce pain as effectively as topical benzocaine during greater palatine nerve block injections? Is there any adverse reactions during and after application of topical ice and 20 % benzocaine gel? 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.

Official Title
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Effectiveness of Pre Injection Use of Cryoanesthesia as Compared to Topical Anesthetic Gel in Reducing Pain Perception During Palatal Injections

Conditions
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Pain

Intervention / Treatment
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* Drug: Topical Benzocaine
* Other: Topical ice


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinically healthy patients ASA I and ASA II with intact palatal mucosa on both sides Procedures that needs administration of greater palatine nerve block Exclusion Criteria: Hypersensitivity to local anesthetic agent Patient who are physically and mentally sub normal Presence of palatal mucosal lesions Patients on long term neuromodulators for chronic pain Patient not consenting to participate in the study

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Cross sectional comparative split mouth study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Drug Arm :Topical benzocaine<br>since its a split mouth study one half of the hard palate will receive topical benzocaine i.e Group A | Drug: Topical Benzocaine<br>* Benzocaine topical anesthetic gel will be used a pre-injection anesthetic on one half of the palate before giving greater palatine nerve block<br>|
| Active Comparator: Topical ice<br>Other half of the palate will receive topical ice i.e Group B | Other: Topical ice<br>* For the other half of the palate topical ice would be used before greater palatine nerve block<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| subjective pain perception during greater palatine nerve block injection | measured using Visual analogue Scale (VAS) - The Visual Analogue Scale (VAS) consisting of a 100 mm straight line with the endpoints marked to denote extreme limits on the left as 'no pain at all' and on the right as 'pain as bad as it could be' was used to record the pain score . The patient was asked to mark their pain level on the line between the two endpoints after receiving the palatal injection. The distance between 'no pain at all' and the mark defined the subject's pain which was measured in millimeters. | Immediatley after the injection | 
| objective pain perception during greater palatine nerve block injection | measured using Sound, Eye and Motor (SEM) scale -The SEM scale was used in the assessment of the relationship between pain and the reactions which the sensation of pain generates in the patient's eyes, bodily movements and verbal expressions of discomfort | During the injection procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse effects | Immediate adverse side effects like burning/stinging sensation, local hypersensitivity reaction (urticaria, erythema, itching) and immediate systemic effects (dizziness, drowsiness, palpitations) were assessed; marked as 0: absent and 1: present. | upto 30 minutes after the injection | 
| Acceptability regarding the use of either topical ice or topical benzocaine | The overall patient perception regarding the use of topical ice and topical benzocaine as a preanesthetic agent was assessed using a 5 point Likert scale containing 5 response options that consisted of two extreme sides and a neutral option. The five response options were: 1.Very bad, 2 Bad, 3. satisfactory 4. Good and 5. Very Good | 5 minutes after application |