Ethyl Chloride Versus 5% Lidocaine for Topical Anesthesia of Oral Mucosa

Pain Clinical Trial

Official title:

Ethyl Chloride-Endo Ice Versus 5% Lidocaine for Topical Anesthesia of Oral Mucosa - a Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05306470
• Other study ID #: Local Anesthetic
• Status: Completed
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: April 30, 2022

Study information

• Verified date: August 2022
• Source: Altamash Institute of Dental Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Local anesthesia in the oral cavity is a pain full experience for the patient. All means should be made to reduce the pain and anxiety of the patient for needle stick procedures. My study aims in elevating the pain experienced by the patient during this procedure by using either cold application with ethyl chloride or 5% lidocaine gel.

Description:

Local anesthetic procedure is always a dreadful experience for the patient specially for the patients who are already in pain . It is a job of the dentist to provide a painless dental treatment from the very beginning. Most dental procedures require administration of local anesthesia for a painless procedure with local anesthesia procedure being painful itself with the administration of needle in the oral cavity. Dentist everyday in their practice utilise various techniques and procedures in alleviating this painful experience with either application of lidocaine gel or spray . Numbing the oral mucosa with cold application is well documented and tested therefore my study aims in application of ethyl chloride spray on cotton pallet for a duration of 30 seconds in producing the desired numbing effect of the oral mucosa before infiltration of local anesthesia in alleviating the needle prick sensation perceived by the patient.

Pain level is assigned to one of four categorical scores using visual analogue scale

1. :None(0)

2. : Mild (1-3)

3. : Moderate (4-6)

4. : Severe (7-10)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: April 30, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• No medical history

• No age restrictions

• Patients suffering from Symptomatic Irreversible Pulpitis requiring buccal infiltration

Exclusion Criteria:

• Patients having any medical conditions considered to affect patient safety or the quality of the study

• if they had any known hypersensitivity to local anaesthetics of amide type or any of the other contents in the substance used

Related Conditions & MeSH terms

• Pain
• Pulpitis
• Symptomatic Irreversible Pulpitis

Intervention

Procedure:
• Ethyl chloride
Application of ethyl chloride for a cooling effect to numb the area for oral infiltration anesthetic
• 5% lidocaine gel
Application of 5% lidocaine gel to numb the area for oral infiltration anesthetic

Locations

Country	Name	City	State
Pakistan	Hira Danish	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Altamash Institute of Dental Medicine

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post oral local anesthetic infiltration pain	Post administration of oral local anesthetic infiltration pain will be measured by using Visual Analogue Scale(VAS) which is an 10-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured	immediately after completion of administration of oral local anesthetic infiltration within 60 seconds