Comparative efficacy of various topical anesthetics during dental injection in pediatric patients
| ISRCTN | ISRCTN11021678 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11021678 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Funder No. 501100020595 |
| Sponsor | Damascus University |
| Funder | Damascus University |
- Submission date
- 06/11/2023
- Registration date
- 07/11/2023
- Last edited
- 21/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Lidocaine is a rapid onset amine–amide anesthetic. In addition, it is widely acceptable due to its potency and low toxicity. Lidocaine gel, to date, is the gold standard topical anesthetic. However, benzocaine was superior to lignocaine gel in relieving pain during IANB, and it was the most favorite topical anesthetic among dental practitioners. 8% lidocaine gel was superior to 2% lidocaine gel in topical ocular anesthesia during intravitreal injection, and higher lidocaine concentrations do not cause toxicity. However, 8% lidocaine gel effectiveness in alleviating pain during dental injections has not been extensively studied. A eutectic mixture of local anesthetics (EMLA) is a topical cream containing a combination of 2.5% lidocaine and 2.5% prilocaine, which has gained popularity in recent years. EMLA is a potent topical anesthetic cream that belongs to the amide group of local anesthetics. In addition, it has been used on oral mucosa to reduce pain during dental treatments such as gingival probing, periodontal scaling, root planning, and other minor dental treatments. However, research comparing EMLA cream and lidocaine gel was not conclusive. In addition, studies comparing various topical anesthetics during IANB administration are scarce. Hence, this study aimed to evaluate the efficacy of 5% EMLA cream and 8% lidocaine gel in reducing pain during IANB compared with 20% Benzocaine in children aged 6-10 years.
Who can participate?
Children aged 6-10 years requiring non-urgent dental treatment under IANB.
What does the study involve?
Patients were randomized using the randomization online software https://www.randomizer.org/. A simple randomization method was applied to randomly allocate patients into 3 groups in a ratio of 1:1:1.
This was a triple-blind trial where patients, clinicians, and data analysts were blinded to which experimental arms patients were allocated.
The participants were randomly assigned into 3 groups. The first group received 20% benzocaine gel (control group). The second group received 8% lidocaine gel. The third group received 5% EMLA cream. Each topical anesthetic was applied in an amount of 0.3 mL using a cotton swab for 2 minutes at the site of IANB administration after drying the mucosa. A conventional IANB was performed using a dental carpule syringe (Dental carpule syringe, Dental Laboratorio) and a 27-gauge x ¾ inch needle (Disposable Dental Needles, J Morita). The needle was inserted between the pterygomandibular raphe and the coronoid notch then aspiration was performed, and 1.8 mL of 2% lidocaine with epinephrine 1:80,000 solution (2% Lidocaine HCL Injection, Huons Co., Ltd, Seongnam) was deposited.
What are the possible benefits and risks of participating?
Possible benefits are: Performing non-urgent dental treatment in the mandibular arch such as, pulpotomy, serial extraction, and pulpectomy.
Possible risk is: IANB will be painful if the topical anesthetic is not effective.
Where is the study run from?
Damascus University (Syria)
When is the study starting and how long is it expected to run for?
Who is funding the study?
Damascus University (Syria)
Who is the main contact?
Dr Mawia Karkoutly, Mawiamaherkarkoutly@hotmail.com
Contact information
Public, Scientific, Principal investigator
Mazzeh Highway
Damascus
-
Syria
 ORCID ID |
0000-0003-0227-1560 |
|---|---|
| Phone | +963 992647528 |
| mawia95.karkoutly@damascusuniversity.edu.sy |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Triple‐blind randomized parallel‐group active-controlled trial with three arms |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Comparative efficacy of various topical anesthetics during inferior alveolar nerve block in pediatric patients: a randomized clinical trial |
| Study objectives | The null hypothesis was that no statistically significant difference would be noted in efficacy of 5% EMLA cream, 8% lidocaine gel, and benzocaine 20% gel in reducing pain from needle stick in children during the inferior alveolar nerve block. |
| Ethics approval(s) |
Approved 25/04/2023, Ethical and Scientific Committee of Damascus University (Damascus University, Mazzeh Highway, Damascus, -, Syria; +963 992647528; dean.dent@damascusuniversity.edu.sy), ref: N3905 |
| Health condition(s) or problem(s) studied | Dental pain |
| Intervention | Patients were randomized using the randomization online software https://www.randomizer.org/. A simple randomization method was applied to randomly allocate patients into 3 groups in a ratio of 1:1:1. This was a triple-blind trial where patients, clinicians, and data analysts were blinded to which experimental arms patients were allocated. The participants were randomly assigned into 3 groups. The first group received 20% benzocaine gel (control group). The second group received 8% lidocaine gel. The third group received 5% EMLA cream. Each topical anesthetic was applied in an amount of 0.3 mL using a cotton swab for 2 minutes at the site of IANB administration after drying the mucosa. A conventional IANB was performed using a dental carpule syringe (Dental carpule syringe, Dental Laboratorio) and a 27-gauge x ¾ inch needle (Disposable Dental Needles, J Morita). The needle was inserted between the pterygomandibular raphe and the coronoid notch then aspiration was performed, and 1.8 mL of 2% lidocaine with epinephrine 1:80,000 solution (2% Lidocaine HCL Injection, Huons Co., Ltd, Seongnam) was deposited. |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 5% EMLA cream, 8% lidocaine gel, benzocaine 20% gel, 2% lidocaine with epinephrine 1:80,000 |
| Primary outcome measure(s) |
1. Pulse rate assessment. Participants’ pulse rate was recorded using a finger pulse oximeter (Alpha, Prolinx GmbH) at two time points: (1) at baseline, before IANB administration. (2) Immediately after IANB administration. |
| Key secondary outcome measure(s) |
There are no secondary outcome measures |
| Completion date | 14/09/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Years |
| Upper age limit | 10 Years |
| Sex | All |
| Target sample size at registration | 45 |
| Total final enrolment | 45 |
| Key inclusion criteria | 1. Children aged 6-10 years. 2. Healthy children. 3. Children with no previous dental experience. 4. Children requiring IANB for non-urgent dental treatment. |
| Key exclusion criteria | 1. Children are allergic to the anesthetic agents used. 2. Children with dental abscesses and/or fascial space infections. 3. Special health care needs children. |
| Date of first enrolment | 06/06/2023 |
| Date of final enrolment | 14/09/2023 |
Locations
Countries of recruitment
- Syria
Study participating centre
Damascus
N/A
Syria
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Mawiamaherkarkoutly@hotmail.com |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 27/11/2024 | 21/01/2025 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
21/01/2025: Publication reference and total final enrolment added.
07/11/2023: Trial's existence confirmed by Damascus University.
