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

December 2, 2023 updated by: Siddhartha Rai, B.P. Koirala Institute of Health Sciences

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Nepal
    • Koshi
      • Dharān Bāzār, Koshi, Nepal, 56700
        • B.P Koirala Institute of Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
subjective pain perception during greater palatine nerve block injection
Time Frame: Immediatley after the 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
Time Frame: During the injection procedure
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
Time Frame: upto 30 minutes after the injection
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
Time Frame: 5 minutes after application

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

B.P. Koirala Institute of Health Sciences

Investigators

  • Study Chair: Mehul Jaisani, MDS, B.P. Koirala Insititute of Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 19, 2021

Primary Completion (Actual)

September 20, 2021

Study Completion (Actual)

January 5, 2022

Study Registration Dates

First Submitted

September 5, 2023

First Submitted That Met QC Criteria

December 2, 2023

First Posted (Estimated)

December 11, 2023

Study Record Updates

Last Update Posted (Estimated)

December 11, 2023

Last Update Submitted That Met QC Criteria

December 2, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 556/077/078

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD that underlie results in a publication

IPD Sharing Time Frame

Starting 3 months after publication

IPD Sharing Access Criteria

via email

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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