Effect of DrugEarly Phase 1NCT05060913
Emla Cream Versus Benzocaine on Analgesia
A Early Phase 1 study testing EMLA Cream and Benzocaine Gel in people with Effect of Drug, run by Dow University of Health Sciences at 1 site in Pakistan.
Trial summary
EMLA is proven to be better in achieving pain control as topical anesthesia than benzocaine at palatal mucosa. So this research is done to compare its effectiveness at buccal mucosa. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Effect of Drug
- What is being tested?
- EMLA Cream and Benzocaine Gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 sitePakistan
- Study dates
- 17 Nov 2021to 4 Mar 2022
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients indicated for bilateral extraction and requiring local anesthesia technique.
- Patients in the age group of 18 to 35 years.
- Patients willing to take part in study.
Who cannot join
- Patients not willing to participate in the study
- Patients presenting with local inflammation / tenderness at site of injection
- Patients who are allergic to local anesthesia
- Patients on antidepressant or anti-psychotic drugs
- Patient with history of any medical condition.
- Patient with history of methemoglobinemia
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Dr. Ishrat-ul-Ebad institute of oral health sciences
Karachi, Sindh, 775500
About this study
Official title: Upshots of 5% Emla Cream Versus 20% Benzocaine on Pre-Injection Analgesia.
EMLA is proven to be better in achieving pain control as topical anesthesia than benzocaine at palatal mucosa. So this research is done to compare its effectiveness at buccal mucosa.
Methods:
A total number of 70 patients attending DOW ojha hospital, fulfilling inclusion criteria and undergoing extraction of bilateral teeth will be included in this study. Approval of data collection will be sought from the Institutional ethical review board ¬(IERB) of Dow university of health sciences (DUHS) for this study. the participants will be briefed about the nature and purpose of the study including visual analogue scale (VAS). They will be ensured that their information will be used for the study purpose only. Informed consent from the participants will be obtained. Complete history from patients will be taken. The sites will be divided into condition A- 5% EMLA and Condition B - 20% Benzocaine Gel. After marking injection sites, principal investigator will leave the room and the consultant will apply 5% EMLA gel at experimental area and 20% Benzocaine gel at control area. After pre-treatment with topical anesthesia the consultant will administer local anesthesia to both sides. Then Principal investigator will be signaled into the room and patient will be assessed though visual analogue scale by him and will be confirmed by supervisor.
Read the detailed description
The concept of dental pain is a true fear for many people. In dentistry, management of pain and anxiety has evolved through behavior modification and oral and intravenous sedatives. Whereas local anesthesia is known as the backbone of the profession. Over the years, methods have been introduced to reduce the pricking pain of local anesthesia injection. There are so many factors which help reduce the pain caused by local anesthesia injection such as warming the local anesthetic agent, specific size of needle gauge, a certain type of anesthetic solution and topical anesthetics. Topical anesthetics are used at insertion sites before injections to reduces the slight discomfort with insertion of the needle. [1,2,3] OneaofatheaTopicalaanesthetics widelyaused for dental proceduresaincludesaBenzocaine.[4] Benzocaine is anaFDA-approved drugawhichaisaavailable in various forms and concentrations. In the 20% concentration, benzocaineagel is the most commonly used topical anesthetic in dentistry, withaanaonsetatimeaofa30asecondsaandadurationaofa5-15aminutes. EMLA is a eutectic mixture of the two local anesthetics, prilocaine and lidocaine which melt at lower temperatures than any of its components, permitting higher concentrations of anesthetics for use.[5] It is used to reduce the pain associated with venous cannulation.
Past studies have reported the pharmacologic and the psychological effects on pain control by benzocaine and Eutectic mixture of local anesthetics (EMLA). However, there is no valuable data on the effect of the simultaneous use 5% EMLA and 20% Benzocaineaonapainaperceptionaduring injectionainaoralamucosaainapopulationaof Karachi. The presentastudyawasadesignedato evaluate the effect of topical application of 5% EMLAaand 20% Benzocaine in an adult population in reducing pain of injection of the local anesthetic agent.
Methods:
A total number of 70 patients attending DOW ojha hospital, fulfilling inclusion criteria and undergoing extraction of bilateral teeth will be included in this study. Approval of data collection will be sought from the Institutional ethical review board ¬(IERB) of Dow university of health sciences (DUHS) for this study. the participants will be briefed about the nature and purpose of the study including visual analogue scale (VAS). They will be ensured that their information will be used for the study purpose only. Informed consent from the participants will be obtained. Complete history from patients will be taken. The sites will be divided into condition A- 5% EMLA and Condition B - 20% Benzocaine Gel. After marking injection sites, principal investigator will leave the room and the consultant will apply 5% EMLA gel at experimental area and 20% Benzocaine gel at control area. After pre-treatment with topical anesthesia the consultant will administer local anesthesia to both sides. Then Principal investigator will be signaled into the room and patient will be assessed though visual analogue scale by him and will be confirmed by supervisor.
- Conditions
- Effect of Drug
- Being tested
- EMLA Cream, Benzocaine Gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMLA CreamDrug
Also called 2.5% Lidocaine and 2.5% Prilocaine
Effect of 5% Emla cream on pricking pain measured on VAS scale.
Benzocaine GelDrug
Also called 20% Benzocaine
Effect of 20% Benzocaine gel on pricking pain measured on VAS scale.
| Study group | Role | What they receive |
|---|---|---|
| 5% EMLA Cream | Experimental | EMLA cream will be applied over buccal mucosa of one side for 1.5 minutes of Maxillary of Mandibular anterior teeth. Receives: Drug: EMLA Cream |
| 20% Benzocaine gel | Active comparator | Benzocaine gel will be applied over buccal mucosa on another side for 1.5 minutes of Maxillary of Mandibular anterior teeth. Receives: Drug: Benzocaine Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achievement of local anesthesia
local anesthesia will be assessed with the help of Visual Analog Scale. VAS score must be '0' while pricking injection for applying Local anesthesia.
Measured: Reading on VAS will be taken after applying EMLA cream for 1.5 minutes.
Achievement of local anesthesia
local anesthesia will be assessed with the help of Visual Analog Scale. VAS score must be '0' while pricking injection for applying Local anesthesia.
Measured: Reading on VAS will be taken after applying Benzocaine gel for 1.5 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2021
- Study start17 Nov 2021
- Primary completion2 Mar 2022
- Study completion4 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of DrugStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaharyar Hamid, Dow University of Health Sciences
- Investigators
- Shaharyar hamid, Principal investigator, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05060913
- Sponsor's protocol ID
- ShHamid2190
- Status last verified
- Jul 2022
- First submitted
- 18 Sep 2021
- Last updated
- 29 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Upshots of 5% Emla Cream Versus 20% Benzocaine on Pre-Injection Analgesia.
- ClinicalTrials.gov ID
- NCT05060913
- Acronym / sponsor ID
- ShHamid2190
- Conditions
- Effect of Drug
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 17 Nov 2021 (actual)
- Primary completion
- 2 Mar 2022 (actual)
- Study completion
- 4 Mar 2022 (actual)
- First posted
- 29 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
EMLA is proven to be better in achieving pain control as topical anesthesia than benzocaine at palatal mucosa. So this research is done to compare its effectiveness at buccal mucosa.
Methods:
A total number of 70 patients attending DOW ojha hospital, fulfilling inclusion criteria and undergoing extraction of bilateral teeth will be included in this study. Approval of data collection will be sought from the Institutional ethical review board ¬(IERB) of Dow university of health sciences (DUHS) for this study. the participants will be briefed about the nature and purpose of the study including visual analogue scale (VAS). They will be ensured that their information will be used for the study purpose only. Informed consent from the participants will be obtained. Complete history from patients will be taken. The sites will be divided into condition A- 5% EMLA and Condition B - 20% Benzocaine Gel. After marking injection sites, principal investigator will leave the room and the consultant will apply 5% EMLA gel at experimental area and 20% Benzocaine gel at control area. After pre-treatment with topical anesthesia the consultant will administer local anesthesia to both sides. Then Principal investigator will be signaled into the room and patient will be assessed though visual analogue scale by him and will be confirmed by supervisor.
Detailed description
The concept of dental pain is a true fear for many people. In dentistry, management of pain and anxiety has evolved through behavior modification and oral and intravenous sedatives. Whereas local anesthesia is known as the backbone of the profession. Over the years, methods have been introduced to reduce the pricking pain of local anesthesia injection. There are so many factors which help reduce the pain caused by local anesthesia injection such as warming the local anesthetic agent, specific size of needle gauge, a certain type of anesthetic solution and topical anesthetics. Topical anesthetics are used at insertion sites before injections to reduces the slight discomfort with insertion of the needle. [1,2,3] OneaofatheaTopicalaanesthetics widelyaused for dental proceduresaincludesaBenzocaine.[4] Benzocaine is anaFDA-approved drugawhichaisaavailable in various forms and concentrations. In the 20% concentration, benzocaineagel is the most commonly used topical anesthetic in dentistry, withaanaonsetatimeaofa30asecondsaandadurationaofa5-15aminutes. EMLA is a eutectic mixture of the two local anesthetics, prilocaine and lidocaine which melt at lower temperatures than any of its components, permitting higher concentrations of anesthetics for use.[5] It is used to reduce the pain associated with venous cannulation.
Past studies have reported the pharmacologic and the psychological effects on pain control by benzocaine and Eutectic mixture of local anesthetics (EMLA). However, there is no valuable data on the effect of the simultaneous use 5% EMLA and 20% Benzocaineaonapainaperceptionaduring injectionainaoralamucosaainapopulationaof Karachi. The presentastudyawasadesignedato evaluate the effect of topical application of 5% EMLAaand 20% Benzocaine in an adult population in reducing pain of injection of the local anesthetic agent.
Methods:
A total number of 70 patients attending DOW ojha hospital, fulfilling inclusion criteria and undergoing extraction of bilateral teeth will be included in this study. Approval of data collection will be sought from the Institutional ethical review board ¬(IERB) of Dow university of health sciences (DUHS) for this study. the participants will be briefed about the nature and purpose of the study including visual analogue scale (VAS). They will be ensured that their information will be used for the study purpose only. Informed consent from the participants will be obtained. Complete history from patients will be taken. The sites will be divided into condition A- 5% EMLA and Condition B - 20% Benzocaine Gel. After marking injection sites, principal investigator will leave the room and the consultant will apply 5% EMLA gel at experimental area and 20% Benzocaine gel at control area. After pre-treatment with topical anesthesia the consultant will administer local anesthesia to both sides. Then Principal investigator will be signaled into the room and patient will be assessed though visual analogue scale by him and will be confirmed by supervisor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5% EMLA Cream | Experimental | Drug: EMLA CreamEMLA cream will be applied over buccal mucosa of one side for 1.5 minutes of Maxillary of Mandibular anterior teeth. |
| 20% Benzocaine gel | Active comparator | Drug: Benzocaine GelBenzocaine gel will be applied over buccal mucosa on another side for 1.5 minutes of Maxillary of Mandibular anterior teeth. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients indicated for bilateral extraction and requiring local anesthesia technique.
- Patients in the age group of 18 to 35 years.
- Patients willing to take part in study.
Key exclusion criteria (6 listed)
- Patients not willing to participate in the study
- Patients presenting with local inflammation / tenderness at site of injection
- Patients who are allergic to local anesthesia
- Patients on antidepressant or anti-psychotic drugs
- Patient with history of any medical condition.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMLA CreamAlso: 2.5% Lidocaine and 2.5% PrilocaineEffect of 5% Emla cream on pricking pain measured on VAS scale. | Drug | 5% EMLA Cream |
| Benzocaine GelAlso: 20% BenzocaineEffect of 20% Benzocaine gel on pricking pain measured on VAS scale. | Drug | 20% Benzocaine gel |
Primary outcome
Achievement of local anesthesia
Time frame: Reading on VAS will be taken after applying EMLA cream for 1.5 minutes.
local anesthesia will be assessed with the help of Visual Analog Scale. VAS score must be '0' while pricking injection for applying Local anesthesia.
Achievement of local anesthesia
Time frame: Reading on VAS will be taken after applying Benzocaine gel for 1.5 minutes.
local anesthesia will be assessed with the help of Visual Analog Scale. VAS score must be '0' while pricking injection for applying Local anesthesia.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shaharyar hamid principal investigator
Dow University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing EMLA Cream and Benzocaine Gel in people with Effect of Drug, run by Dow University of Health Sciences at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Achievement of local anesthesia (time frame: Reading on VAS will be taken after applying EMLA cream for 1.5 minutes.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2022.