PainNCT05338983
Effect of Different Approaches of Delivering Local Dental Anesthesia on Pain Perception in Children.
A study testing Topical anesthetic, Avent baby bottle warmer and Sodium bicarbonate in people with Pain and Local Anesthetics, run by Mansoura University at 1 site in Egypt.
Trial summary
The aim of the study is to compare the efficacy of three different approaches of local anesthesia (LA) administration (Warm[37°C] LA, Buffered LA, and BUZZY device) on pain perception to young children ( 6-12 years old) using sound -eye -motor and Wong-Baker FPR scales. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Local Anesthetics, Epinephrine
- What is being tested?
- Topical anesthetic, Avent baby bottle warmer and Sodium bicarbonate
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2022to 1 Jun 2023
- Phase
- Interventional
- 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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children requiring maxillary infiltration LA for dental treatment.
- Cooperative children (positive or definitely positive on Frankel's scale).
- Children are in apparently good health and not taking any medications that will alter their pain perception.
- Children have no history of allergy to Mepivacaine
Who cannot join
- The person responsible does not authorize the participation of the child as a research volunteer.
- Be using pain modulating drugs.
- Patients with a history of hypersensitivity to local anesthetics.
- Patients with a history of systemic diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Different Approaches of Delivering Local Dental Anesthesia on Pain Perception in Children. A Double Blinded Randomized Controlled Clinical Trial.
The aim of the study is to compare the efficacy of three different approaches of local anesthesia (LA) administration (Warm[37°C] LA, Buffered LA, and BUZZY device) on pain perception to young children ( 6-12 years old) using sound -eye -motor and Wong-Baker FPR scales.
Read the detailed description
Pain is an unpleasant sensory and emotional experience associated with actual or potential tissue damage.In pediatric dentistry, the injection of local anesthesia is the most common cause of fear and expected to be painful.So, an effective pain control significantly contributes to an optimal dental treatment in pediatric dentistry.Proper pain prevention may enhance the child's cooperation by building dentist-child trust and reducing fear and/or anxiety during the current or future visit(s). The purpose of this study is to compare the efficacy of three different approaches of LA administration(Warm[37°C] LA, Buffered LA, and BUZZY device) on pain perception to young children ( 6-12 years old) using sound -eye -motor and Wong-Baker FPR scales. This study will be conducted on 80 children aged between 6-12 years from pediatric dental clinic, Faculty of Dentistry, Mansoura University. Children will be divided to 4 equal groups, 20 children each. Three experimental groups, and a (control group) . The 4 groups will be randomly allocated for each technique using block technique of simple random sampling .Randomized block designs are constructed to reduce noise or variance in the data.
Every block will include the equal number of the four groups (three experimental and one control).
- Conditions
- Pain, Local Anesthetics, Epinephrine, Vibration
- Being tested
- Topical anesthetic, Avent baby bottle warmer, Sodium bicarbonate, Buzzy device, Mepivacaine Hydrochloride
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical anestheticDrug
20% Benzocaine gel will be applied on the area of infiltration
Avent baby bottle warmerDevice
Warming device
Sodium bicarbonateDrug
0.1ml of 8.4% of sodium bicarbonate will be removed from the 50ml vial by one ml insulin syringe , directly injected into the local anesthetic cartridge and will be shacked 5 times to mix the solution.
Buzzy deviceDevice
Bee-shaped apparatus consisting of two parts: the main vibrating body of a bee and detachable ice wings.
External application of Buzzy device during administration of dental anesthetic.
Mepivacaine HydrochlorideDrug
Mepivacaine HCL 2% with Epinephrine 1:100,000 Local Anesthetic. Local Dental anesthetic infiltration
| Study group | Role | What they receive |
|---|---|---|
| Control: Traditional local anesthesia | Active comparator | After proper isolation and drying of the injection site, the topical anesthetic gel (20% benzocaine) will be applied to the injection site using sterile cotton tipped applicator for 60 seconds, then the anesthesia (2% mepivacaine hcl with 1:100000 epinephrine) will be administere Receives: Drug: Topical anesthetic; Drug: Mepivacaine Hydrochloride |
| Group A (Warm group) | Experimental | The topical anesthetic gel (20% benzocaine) will be applied to the injection site using sterile cotton tipped applicator for 60 seconds. The cartridge of anesthetic solution will be placed in the baby bottle warmer in 300 ml of cold water (21°C). The anesthetic fluid will be warmed to reach 37°C (98.6°F) ,then the local anesthesia((2% mepivacaine hcl with 1:100000 epinephrine) will be administered Receives: Drug: Topical anesthetic; Device: Avent baby bottle warmer; Drug: Mepivacaine Hydrochloride |
| Group B (Buffered group) | Experimental | The topical anesthetic gel (20% benzocaine) will be applied to the injection site for 60 seconds,0.1ml of 8.4% of sodium bicarbonate will be removed from the 50 ml vial by one ml insulin syringe and directly injected into the local anesthetic cartridge. The cartridge will be shacked 5 times to mix the solution, then the local anesthesia(2% mepivacaine hcl with 1:100000 epinephrine) will be administered. Receives: Drug: Topical anesthetic; Drug: Sodium bicarbonate; Drug: Mepivacaine Hydrochloride |
| Group C (Buzzy group) | Experimental | After the child setting on the dental chair,(20% benzocaine) topical anesthetic gel will be applied to the injection site for 60 seconds. He will be familiar with the Buzzy device by explaining how it works in simple words. The wings of the device will be kept in the freezer. Once the child is ready, the frozen wings will be attached to the device and Buzzy will be placed extra-orally above the area/cheek where local anesthetic will be delivered. Once Buzzy is being held in place by hand, press the button or switch on the top of Buzzy, then the anesthesia (2% mepivacaine hcl with 1:100000 epinephrine) will be administered. Receives: Drug: Topical anesthetic; Device: Buzzy device; Drug: Mepivacaine Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Behavoir
The pain will be analyzed by sound ,eye motor scale An assistant will be trained to measure and calibrate the SEM scale. The assistant will be blinded to the study group to avoid bias.
Measured: During the anesthetic procedure
Self-perception of pain
The pain will be analyzed by the Wong Baker Faces scales
. A set of six cartoon faces will be shown to the child with varying facial expressions ranging from a very smiling face to a very sad face. A brief explanation will be given to the child about each face after which the child will be instructed to choose the face that will describe his/ her feelings while receiving local anesthesia
Measured: Immediately after anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2022
- Study start1 May 2022 (estimated)
- Primary completion1 May 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Children will be divided into 4 equal groups, 20 children each. Three experimental groups, and a(control group) . The 4 groups will be randomly allocated for each technique using block technique of simple random sampling. Randomized block designs are constructed to reduce noise or variance in the data. Every block will include the equal number of the four groups (three experimental and one control).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sahar H Zidan, Principal investigator, Dentist at Ministry of Health B.D.S (2013), Diploma (2016)Nadia M Farrag, Study director, Professor of Pediatric Dentistry Faculty of Dentistry, Mansoura UniversityAhmed H Wahba, Study director, Lecturer of Pediatric Dentistry Faculty of Dentistry Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05338983
- Sponsor's protocol ID
- Dental local anesthesia pain
- Status last verified
- Apr 2022
- First submitted
- 14 Apr 2022
- Last updated
- 29 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Leff DR, Nortley M, Dang V, Bhutiani RP. The effect of local cooling on pain perception during infiltration of local anaesthetic agents, a prospective randomised controlled trial. Anaesthesia. 2007 Jul;62(7):677-82. doi: 10.1111/j.1365-2044.2007.05056.x.
PubMed 17567343Roeber B, Wallace DP, Rothe V, Salama F, Allen KD. Evaluation of the effects of the VibraJect attachment on pain in children receiving local anesthesia. Pediatr Dent. 2011 Jan-Feb;33(1):46-50.
PubMed 21406147Ram D, Hermida LB, Peretz B. A comparison of warmed and room-temperature anesthetic for local anesthesia in children. Pediatr Dent. 2002 Jul-Aug;24(4):333-6.
PubMed 12212876Aravena PC, Barrientos C, Troncoso C, Coronado C, Sotelo-Hitschfeld P. Effect of warming anesthetic on pain perception during dental injection: a split-mouth randomized clinical trial. Local Reg Anesth. 2018 Feb 22;11:9-13. doi: 10.2147/LRA.S147288. eCollection 2018.
PubMed 29503582
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Approaches of Delivering Local Dental Anesthesia on Pain Perception in Children. A Double Blinded Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT05338983
- Acronym / sponsor ID
- Dental local anesthesia pain
- Conditions
- Pain, Local Anesthetics, Epinephrine, Vibration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (estimated)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 21 Apr 2022 (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.
The aim of the study is to compare the efficacy of three different approaches of local anesthesia (LA) administration (Warm[37°C] LA, Buffered LA, and BUZZY device) on pain perception to young children ( 6-12 years old) using sound -eye -motor and Wong-Baker FPR scales.
Detailed description
Pain is an unpleasant sensory and emotional experience associated with actual or potential tissue damage.In pediatric dentistry, the injection of local anesthesia is the most common cause of fear and expected to be painful.So, an effective pain control significantly contributes to an optimal dental treatment in pediatric dentistry.Proper pain prevention may enhance the child's cooperation by building dentist-child trust and reducing fear and/or anxiety during the current or future visit(s). The purpose of this study is to compare the efficacy of three different approaches of LA administration(Warm[37°C] LA, Buffered LA, and BUZZY device) on pain perception to young children ( 6-12 years old) using sound -eye -motor and Wong-Baker FPR scales. This study will be conducted on 80 children aged between 6-12 years from pediatric dental clinic, Faculty of Dentistry, Mansoura University. Children will be divided to 4 equal groups, 20 children each. Three experimental groups, and a (control group) . The 4 groups will be randomly allocated for each technique using block technique of simple random sampling .Randomized block designs are constructed to reduce noise or variance in the data.
Every block will include the equal number of the four groups (three experimental and one control).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Children will be divided into 4 equal groups, 20 children each. Three experimental groups, and a(control group) . The 4 groups will be randomly allocated for each technique using block technique of simple random sampling. Randomized block designs are constructed to reduce noise or variance in the data. Every block will include the equal number of the four groups (three experimental and one control).
| Arm | Type | Receives |
|---|---|---|
| Control: Traditional local anesthesia | Active comparator | Drug: Topical anesthetic, Drug: Mepivacaine HydrochlorideAfter proper isolation and drying of the injection site, the topical anesthetic gel (20% benzocaine) will be applied to the injection site using sterile cotton tipped applicator for 60 seconds, then the anesthesia (2% mepivacaine hcl with 1:100000 epinephrine) will be administere |
| Group A (Warm group) | Experimental | Drug: Topical anesthetic, Device: Avent baby bottle warmer, Drug: Mepivacaine HydrochlorideThe topical anesthetic gel (20% benzocaine) will be applied to the injection site using sterile cotton tipped applicator for 60 seconds. The cartridge of anesthetic solution will be placed in the baby bottle warmer in 300 ml of cold water (21°C). The anesthetic fluid will be warmed to reach 37°C (98.6°F) ,then the local anesthesia((2% mepivacaine hcl with 1:100000 epinephrine) will be administered |
| Group B (Buffered group) | Experimental | Drug: Topical anesthetic, Drug: Sodium bicarbonate, Drug: Mepivacaine HydrochlorideThe topical anesthetic gel (20% benzocaine) will be applied to the injection site for 60 seconds,0.1ml of 8.4% of sodium bicarbonate will be removed from the 50 ml vial by one ml insulin syringe and directly injected into the local anesthetic cartridge. The cartridge will be shacked 5 times to mix the solution, then the local anesthesia(2% mepivacaine hcl with 1:100000 epinephrine) will be administered. |
| Group C (Buzzy group) | Experimental | Drug: Topical anesthetic, Device: Buzzy device, Drug: Mepivacaine HydrochlorideAfter the child setting on the dental chair,(20% benzocaine) topical anesthetic gel will be applied to the injection site for 60 seconds. He will be familiar with the Buzzy device by explaining how it works in simple words. The wings of the device will be kept in the freezer. Once the child is ready, the frozen wings will be attached to the device and Buzzy will be placed extra-orally above the area/cheek where local anesthetic will be delivered. Once Buzzy is being held in place by hand, press the button or switch on the top of Buzzy, then the anesthesia (2% mepivacaine hcl with 1:100000 epinephrine) will be administered. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children requiring maxillary infiltration LA for dental treatment.
- Cooperative children (positive or definitely positive on Frankel's scale).
- Children are in apparently good health and not taking any medications that will alter their pain perception.
- Children have no history of allergy to Mepivacaine
Key exclusion criteria (4 listed)
- The person responsible does not authorize the participation of the child as a research volunteer.
- Be using pain modulating drugs.
- Patients with a history of hypersensitivity to local anesthetics.
- Patients with a history of systemic diseases.
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 |
|---|---|---|
| Topical anesthetic20% Benzocaine gel will be applied on the area of infiltration | Drug | Control: Traditional local anesthesia, Group A (Warm group), Group B (Buffered group), Group C (Buzzy group) |
| Avent baby bottle warmerWarming device | Device | Group A (Warm group) |
| Sodium bicarbonate0.1ml of 8.4% of sodium bicarbonate will be removed from the 50ml vial by one ml insulin syringe , directly injected into the local anesthetic cartridge and will be shacked 5 times to mix the solution. | Drug | Group B (Buffered group) |
| Buzzy deviceBee-shaped apparatus consisting of two parts: the main vibrating body of a bee and detachable ice wings. External application of Buzzy device during administration of dental anesthetic. | Device | Group C (Buzzy group) |
| Mepivacaine HydrochlorideMepivacaine HCL 2% with Epinephrine 1:100,000 Local Anesthetic. Local Dental anesthetic infiltration | Drug | Control: Traditional local anesthesia, Group A (Warm group), Group B (Buffered group), Group C (Buzzy group) |
Primary outcome
Pain Behavoir
Time frame: During the anesthetic procedure
The pain will be analyzed by sound ,eye motor scale An assistant will be trained to measure and calibrate the SEM scale. The assistant will be blinded to the study group to avoid bias.
Self-perception of pain
Time frame: Immediately after anesthesia
The pain will be analyzed by the Wong Baker Faces scales . A set of six cartoon faces will be shown to the child with varying facial expressions ranging from a very smiling face to a very sad face. A brief explanation will be given to the child about each face after which the child will be instructed to choose the face that will describe his/ her feelings while receiving local anesthesia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2022.
- Background: PubMed 17567343Leff DR, Nortley M, Dang V, Bhutiani RP. The effect of local cooling on pain perception during infiltration of local anaesthetic agents, a prospective randomised controlled trial. Anaesthesia. 2007 Jul;62(7):677-82. doi: 10.1111/j.1365-2044.2007.05056.x.
- Background: PubMed 21406147Roeber B, Wallace DP, Rothe V, Salama F, Allen KD. Evaluation of the effects of the VibraJect attachment on pain in children receiving local anesthesia. Pediatr Dent. 2011 Jan-Feb;33(1):46-50.
- Background: PubMed 12212876Ram D, Hermida LB, Peretz B. A comparison of warmed and room-temperature anesthetic for local anesthesia in children. Pediatr Dent. 2002 Jul-Aug;24(4):333-6.
- Background: PubMed 29503582Aravena PC, Barrientos C, Troncoso C, Coronado C, Sotelo-Hitschfeld P. Effect of warming anesthetic on pain perception during dental injection: a split-mouth randomized clinical trial. Local Reg Anesth. 2018 Feb 22;11:9-13. doi: 10.2147/LRA.S147288. eCollection 2018.
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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.
Sahar H Zidan principal investigator
Dentist at Ministry of Health B.D.S (2013), Diploma (2016)
Nadia M Farrag study director
Professor of Pediatric Dentistry Faculty of Dentistry, Mansoura University
Ahmed H Wahba study director
Lecturer of Pediatric Dentistry Faculty of Dentistry Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topical anesthetic, Avent baby bottle warmer and Sodium bicarbonate in people with Pain and Local Anesthetics, run by Mansoura University at 1 site in Egypt.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 29 Apr 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 Egypt. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sahar H Zidan (020122217467, szidan750@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Behavoir (time frame: During the anesthetic procedure). 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?
On the ClinicalTrials.gov record for NCT05338983, which also lists 4 linked publications.
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 Apr 2022.