Ethyl Chloride Versus 5% Lidocaine for Topical Anesthesia of Oral Mucosa
Ethyl Chloride-Endo Ice Versus 5% Lidocaine for Topical Anesthesia of Oral Mucosa - a Randomized Clinical Trial
1 other identifier
interventional
90
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable pain
Started Mar 2022
Shorter than P25 for not_applicable pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2022
CompletedFirst Submitted
Initial submission to the registry
March 15, 2022
CompletedFirst Posted
Study publicly available on registry
April 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2022
CompletedAugust 24, 2022
August 1, 2022
Same day
March 15, 2022
August 21, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (3)
Ethyl chloride
EXPERIMENTALPre cooling done by the application of single spray ethyl chloride on a cotton pellet and placed for 30 seconds at the injection site for numbing effect
5% lidocaine gel
EXPERIMENTAL5% lidocaine gel 2ml applied on a cotton pallet for 30 seconds on the oral mucosa at the site of injection for the numbing effect
control
NO INTERVENTIONLocal anesthesia infiltration is administrated without using any numbing agent
Interventions
Application of ethyl chloride for a cooling effect to numb the area for oral infiltration anesthetic
Application of 5% lidocaine gel to numb the area for oral infiltration anesthetic
Eligibility Criteria
You may qualify if:
- No medical history
- No age restrictions
- Patients suffering from Symptomatic Irreversible Pulpitis requiring buccal infiltration
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hira Danish
Karachi, Sindh, 75500, Pakistan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 15, 2022
First Posted
April 1, 2022
Study Start
March 1, 2022
Primary Completion
March 1, 2022
Study Completion
April 30, 2022
Last Updated
August 24, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share