Local AnaesthesiaNCT05083975
Buzzy System Compared to Topical Anaesthesia During Infiltration Injection in Children.
A study testing Buzzy System, Topical anesthetic and 1.8 ml of 4% articaine hydrochloride with epinephrine 1:100,000 in people with Local Anaesthesia, run by Cairo University at 1 site in Egypt.
Trial summary
Aim of the study is to test the effect of Buzzy System (vibrating device) compared to topical anaesthesia on pain reduction during injection of infiltration anaesthesia in children. Read more about this study
- Who is it for?
- Ages 5 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Local Anaesthesia
- What is being tested?
- Buzzy System, Topical anesthetic and 1.8 ml of 4% articaine hydrochloride with epinephrine 1:100,000
- 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
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 23 Jul 2022to 6 May 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 5 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children classified as cooperative or potentially cooperative according to Wright's classification of child behaviour with rating 3 (positive) or 4 (definitely positive) according to Frankl behaviour rating scale.
- Children aged 5-8 years old.
- Patients who need maxillary buccal infiltration anesthesia.
Who cannot join
- Children with any neurological or psychological disorders.
- Children with known allergy to topical or local anesthetic agents.
- Parental refusal for participation.
- Children with previous history of local anesthesia injection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Buzzy System (Vibrating Device) Compared to Topical Anaesthesia on Pain Reduction During Injection of Infiltration Anaesthesia in Children: A Randomized Clinical Trial.
Aim of the study is to test the effect of Buzzy System (vibrating device) compared to topical anaesthesia on pain reduction during injection of infiltration anaesthesia in children.
- Conditions
- Local Anaesthesia
- Being tested
- Buzzy System, Topical anesthetic, 1.8 ml of 4% articaine hydrochloride with epinephrine 1:100,000
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buzzy SystemDevice
Vibrating Device
Topical anestheticDrug
20% benzocaine gel (Opahl Topical Gel)
1.8 ml of 4% articaine hydrochloride with epinephrine 1:100,000Drug
Local dental anesthetic agent
| Study group | Role | What they receive |
|---|---|---|
| Buzzy System | Experimental | Maxillary anesthetic infiltration injection using a conventional 2-ml syringe and a short needle after activating the buzzy device extra orally proximal to the site of injection for 30-60 seconds. Receives: Device: Buzzy System; Drug: 1.8 ml of 4% articaine hydrochloride with epinephrine 1:100,000 |
| Control | Active comparator | Maxillary anesthetic infiltration injection using a conventional 2-ml syringe and a short needle after application of 20% Benzocaine topical anesthestic gel. Receives: Drug: Topical anesthetic; Drug: 1.8 ml of 4% articaine hydrochloride with epinephrine 1:100,000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Perception during local anaesthesia injection
Pain intensity directly after the injection recorded by Wong-Baker faces pain rating scale and Faces, Legs, Arms, Crying, Consolability (FLACC) scale.
Measured: Procedure (During and immediately after the administration of local anesthesia)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study start23 Jul 2022
- Primary completion22 Dec 2022
- Study completion6 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Local AnaesthesiaStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Mahmoud Mohamed Mahmoud, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05083975
- Sponsor's protocol ID
- Buzzy System in Children.
- Status last verified
- Mar 2024
- First submitted
- 6 Oct 2021
- Last updated
- 21 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Merkel SI, Voepel-Lewis T, Shayevitz JR, Malviya S. The FLACC: a behavioral scale for scoring postoperative pain in young children. Pediatr Nurs. 1997 May-Jun;23(3):293-7.
PubMed 9220806Shilpapriya M, Jayanthi M, Reddy VN, Sakthivel R, Selvaraju G, Vijayakumar P. Effectiveness of new vibration delivery system on pain associated with injection of local anesthesia in children. J Indian Soc Pedod Prev Dent. 2015 Jul-Sep;33(3):173-6. doi: 10.4103/0970-4388.160343.
PubMed 26156269Hegde KM, R N, Srinivasan I, D R MK, Melwani A, Radhakrishna S. Effect of vibration during local anesthesia administration on pain, anxiety, and behavior of pediatric patients aged 6-11 years: A crossover split-mouth study. J Dent Anesth Pain Med. 2019 Jun;19(3):143-149. doi: 10.17245/jdapm.2019.19.3.143. Epub 2019 Jun 30.
PubMed 31338420Alanazi KJ, Pani S, AlGhanim N. Efficacy of external cold and a vibrating device in reducing discomfort of dental injections in children: A split mouth randomised crossover study. Eur Arch Paediatr Dent. 2019 Apr;20(2):79-84. doi: 10.1007/s40368-018-0399-8. Epub 2018 Dec 5.
PubMed 30519955Suohu T, Sharma S, Marwah N, Mishra P. A Comparative Evaluation of Pain Perception and Comfort of a Patient Using Conventional Syringe and Buzzy System. Int J Clin Pediatr Dent. 2020 Jan-Feb;13(1):27-30. doi: 10.5005/jp-journals-10005-1731.
PubMed 32581474AlHareky M, AlHumaid J, Bedi S, El Tantawi M, AlGahtani M, AlYousef Y. Effect of a Vibration System on Pain Reduction during Injection of Dental Anesthesia in Children: A Randomized Clinical Trial. Int J Dent. 2021 Jan 30;2021:8896408. doi: 10.1155/2021/8896408. eCollection 2021.
PubMed 33564311Faghihian R, Rastghalam N, Amrollahi N, Tarrahi MJ. Effect of vibration devices on pain associated with dental injections in children: A systematic review and meta-analysis. Aust Dent J. 2021 Mar;66(1):4-12. doi: 10.1111/adj.12811. Epub 2020 Dec 17.
PubMed 33258142Zielinski J, Morawska-Kochman M, Zatonski T. Pain assessment and management in children in the postoperative period: A review of the most commonly used postoperative pain assessment tools, new diagnostic methods and the latest guidelines for postoperative pain therapy in children. Adv Clin Exp Med. 2020 Mar;29(3):365-374. doi: 10.17219/acem/112600.
PubMed 32129952Hindocha N, Manhem F, Backryd E, Bagesund M. Ice versus lidocaine 5% gel for topical anaesthesia of oral mucosa - a randomized cross-over study. BMC Anesthesiol. 2019 Dec 16;19(1):227. doi: 10.1186/s12871-019-0902-8.
PubMed 31842771Al-Melh MA, Andersson L. Comparison of topical anesthetics (EMLA/Oraqix vs. benzocaine) on pain experienced during palatal needle injection. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2007 May;103(5):e16-20. doi: 10.1016/j.tripleo.2006.11.033. Epub 2007 Feb 27.
PubMed 17331753
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Buzzy System (Vibrating Device) Compared to Topical Anaesthesia on Pain Reduction During Injection of Infiltration Anaesthesia in Children: A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT05083975
- Acronym / sponsor ID
- Buzzy System in Children.
- Conditions
- Local Anaesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 23 Jul 2022 (actual)
- Primary completion
- 22 Dec 2022 (actual)
- Study completion
- 6 May 2023 (actual)
- First posted
- 19 Oct 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.
Aim of the study is to test the effect of Buzzy System (vibrating device) compared to topical anaesthesia on pain reduction during injection of infiltration anaesthesia in children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Buzzy System | Experimental | Device: Buzzy System, Drug: 1.8 ml of 4% articaine hydrochloride with epinephrine 1:100,000Maxillary anesthetic infiltration injection using a conventional 2-ml syringe and a short needle after activating the buzzy device extra orally proximal to the site of injection for 30-60 seconds. |
| Control | Active comparator | Drug: Topical anesthetic, Drug: 1.8 ml of 4% articaine hydrochloride with epinephrine 1:100,000Maxillary anesthetic infiltration injection using a conventional 2-ml syringe and a short needle after application of 20% Benzocaine topical anesthestic gel. |
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children classified as cooperative or potentially cooperative according to Wright's classification of child behaviour with rating 3 (positive) or 4 (definitely positive) according to Frankl behaviour rating scale.
- Children aged 5-8 years old.
- Patients who need maxillary buccal infiltration anesthesia.
Key exclusion criteria (4 listed)
- Children with any neurological or psychological disorders.
- Children with known allergy to topical or local anesthetic agents.
- Parental refusal for participation.
- Children with previous history of local anesthesia injection.
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 |
|---|---|---|
| Buzzy SystemVibrating Device | Device | Buzzy System |
| Topical anesthetic20% benzocaine gel (Opahl Topical Gel) | Drug | Control |
| 1.8 ml of 4% articaine hydrochloride with epinephrine 1:100,000Local dental anesthetic agent | Drug | Buzzy System, Control |
Primary outcome
Pain Perception during local anaesthesia injection
Time frame: Procedure (During and immediately after the administration of local anesthesia)
Pain intensity directly after the injection recorded by Wong-Baker faces pain rating scale and Faces, Legs, Arms, Crying, Consolability (FLACC) scale.
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 21 Mar 2024.
- Background: PubMed 9220806Merkel SI, Voepel-Lewis T, Shayevitz JR, Malviya S. The FLACC: a behavioral scale for scoring postoperative pain in young children. Pediatr Nurs. 1997 May-Jun;23(3):293-7.
- Background: PubMed 26156269Shilpapriya M, Jayanthi M, Reddy VN, Sakthivel R, Selvaraju G, Vijayakumar P. Effectiveness of new vibration delivery system on pain associated with injection of local anesthesia in children. J Indian Soc Pedod Prev Dent. 2015 Jul-Sep;33(3):173-6. doi: 10.4103/0970-4388.160343.
- Background: PubMed 31338420Hegde KM, R N, Srinivasan I, D R MK, Melwani A, Radhakrishna S. Effect of vibration during local anesthesia administration on pain, anxiety, and behavior of pediatric patients aged 6-11 years: A crossover split-mouth study. J Dent Anesth Pain Med. 2019 Jun;19(3):143-149. doi: 10.17245/jdapm.2019.19.3.143. Epub 2019 Jun 30.
- Background: PubMed 30519955Alanazi KJ, Pani S, AlGhanim N. Efficacy of external cold and a vibrating device in reducing discomfort of dental injections in children: A split mouth randomised crossover study. Eur Arch Paediatr Dent. 2019 Apr;20(2):79-84. doi: 10.1007/s40368-018-0399-8. Epub 2018 Dec 5.
- Background: PubMed 32581474Suohu T, Sharma S, Marwah N, Mishra P. A Comparative Evaluation of Pain Perception and Comfort of a Patient Using Conventional Syringe and Buzzy System. Int J Clin Pediatr Dent. 2020 Jan-Feb;13(1):27-30. doi: 10.5005/jp-journals-10005-1731.
- Background: PubMed 33564311AlHareky M, AlHumaid J, Bedi S, El Tantawi M, AlGahtani M, AlYousef Y. Effect of a Vibration System on Pain Reduction during Injection of Dental Anesthesia in Children: A Randomized Clinical Trial. Int J Dent. 2021 Jan 30;2021:8896408. doi: 10.1155/2021/8896408. eCollection 2021.
- Background: PubMed 33258142Faghihian R, Rastghalam N, Amrollahi N, Tarrahi MJ. Effect of vibration devices on pain associated with dental injections in children: A systematic review and meta-analysis. Aust Dent J. 2021 Mar;66(1):4-12. doi: 10.1111/adj.12811. Epub 2020 Dec 17.
- Background: PubMed 32129952Zielinski J, Morawska-Kochman M, Zatonski T. Pain assessment and management in children in the postoperative period: A review of the most commonly used postoperative pain assessment tools, new diagnostic methods and the latest guidelines for postoperative pain therapy in children. Adv Clin Exp Med. 2020 Mar;29(3):365-374. doi: 10.17219/acem/112600.
- Background: PubMed 31842771Hindocha N, Manhem F, Backryd E, Bagesund M. Ice versus lidocaine 5% gel for topical anaesthesia of oral mucosa - a randomized cross-over study. BMC Anesthesiol. 2019 Dec 16;19(1):227. doi: 10.1186/s12871-019-0902-8.
- Background: PubMed 17331753Al-Melh MA, Andersson L. Comparison of topical anesthetics (EMLA/Oraqix vs. benzocaine) on pain experienced during palatal needle injection. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2007 May;103(5):e16-20. doi: 10.1016/j.tripleo.2006.11.033. Epub 2007 Feb 27.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Buzzy System, Topical anesthetic and 1.8 ml of 4% articaine hydrochloride with epinephrine 1:100,000 in people with Local Anaesthesia, run by Cairo 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 3 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: finished, as of the sponsor's last update on 21 Mar 2024. 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?
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?
Pain Perception during local anaesthesia injection (time frame: Procedure (During and immediately after the administration of local anesthesia)). 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 NCT05083975, which also lists 10 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 21 Mar 2024.