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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06165432
• Other study ID #: 556/077/078
• Status: Completed
• Phase: Phase 4
• Start date: March 19, 2021
• Est. completion date: January 5, 2022

Study information

• Verified date: December 2023
• Source: B.P. Koirala Institute of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 5, 2022
• Est. primary completion date: September 20, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

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

Other:
• Topical ice
For the other half of the palate topical ice would be used before greater palatine nerve block

Locations

Country	Name	City	State
Nepal	B.P Koirala institute of health sciences	Dharan Bazar	Koshi

Sponsors (1)

Lead Sponsor	Collaborator
B.P. Koirala Institute of Health Sciences

Country where clinical trial is conducted

Nepal, 

References & Publications (32)

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* Note: There are 32 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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

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