AnesthesiaNCT07886333
Buzzy Bee for Pain and Anxiety Control During Pediatric Dental Local Anesthesia
A study testing Intervention A: Buzzy® Bee-Assisted Local Anesthesia and Intervention B: Conventional Local Anesthesia Technique in people with Anesthesia and Anxiety, run by Tanta University at 1 site in Egypt.
Trial summary
The present study will evaluate the effectiveness of Buzzy Bee in reducing pain and physiological responses during maxillary buccal infiltration in children aged 5-7 years compared with a conventional injection protocol. Read more about this study
- Who is it for?
- Ages 5 to 7 years
- Conditions the study is for
- Anesthesia, Anxiety, Pain
- What is being tested?
- Intervention A: Buzzy® Bee-Assisted Local Anesthesia and Intervention B: Conventional Local Anesthesia Technique
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2025to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Systemically healthy children classified as ASA-I.
- Children requiring bilateral maxillary buccal infiltration local anesthesia across at least two separate dental treatment appointments.
- Co-operative child with a Frankl behavior rating of 3,4.
- Children free from any neurological or psychological disorder.
Who cannot join
- Children with known allergy to local anesthetic agents.
- Children with developmental delays, intellectual disabilities, or severe uncooperative behavior (Frankl rating 1 or 2).
- Children presenting with acute dental pain, swelling, or active infection at the injection site.
- Parental refusal to provide written informed consent for participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
faculty of dentistry, Tanta university
Tanta
shaimaa eldesouky, assistant professor, 01008994242, shaimaaeldesouky@dent.tanta.edu.eg
Hala Khaled Mohamed Saber, master
About this study
Official title: Effectiveness of Buzzy Bee Device in Anxiety Reduction and Pain Control During Local Anesthesia Administration
The present study will evaluate the effectiveness of Buzzy Bee in reducing pain and physiological responses during maxillary buccal infiltration in children aged 5-7 years compared with a conventional injection protocol.
Read the detailed description
Pain control during local anesthetic administration is essential in pediatric dentistry, as injection-related discomfort may increase anxiety and affect children's cooperation. The present study will evaluate the effectiveness of Buzzy Bee in reducing pain and physiological responses during maxillary buccal infiltration in children aged 5-7 years compared with a conventional injection protocol.
The study includes 40 children attending the Outpatient Clinic of the Pediatric Dentistry Department, Faculty of Dentistry, Tanta University. A randomized crossover design will be used, with each child receiving both interventions during two visits separated by one week. Participants will be randomly allocated to the AB or BA sequence.
Both interventions involved topical application of 4% lidocaine hydrochloride gel for two minutes, followed by maxillary buccal infiltration using 4% articaine with epinephrine 1:200,000. The Buzzy Bee protocol incorporated external cold and vibration, whereas the conventional protocol used audiovisual distraction.
Heart rate will be recorded before, during, and after injection. Pain will be assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) scale and the Wong-Baker Faces Pain Rating Scale.
- Conditions
- Anesthesia, Anxiety, Pain, Children
- Being tested
- Intervention A: Buzzy® Bee-Assisted Local Anesthesia, Intervention B: Conventional Local Anesthesia Technique
- Keywords
- Buzzy Bee Device, local anesthesia, dental anxiety, pain control, crossover
- Medical subject headings
- Anxiety Disorders, Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention A: Buzzy® Bee-Assisted Local AnesthesiaDevice
Behavioral Guidance: Child preparation using the Tell-Show-Do technique.
Device Application: The Buzzy® Bee device (equipped with pre-frozen wings) is activated to provide combined high-frequency vibration and cryotherapy. It is placed on the extraoral cheek skin approximately 1-2 cm proximal to the target injection site for 30 seconds prior to needle insertion and remains continuously active throughout needle insertion and solution deposition.
Topical Anesthesia: Injection site is isolated with cotton rolls, dried, and treated with 2% Lidocaine gel applied for 2 minutes via a sterile cotton swab.
Local Anesthesia Injection: Maxillary buccal infiltration is delivered using 4% Articaine with 1:200,000 epinephrine via a sterile short 27-gauge needle, deposited slowly over 60 seconds while Buzzy® Bee is running.
Intervention B: Conventional Local Anesthesia TechniqueDrug
Behavioral Guidance: Child preparation using standard Tell-Show-Do behavioral guidance paired with routine audiovisual distraction (cartoons displayed on a chair-side screen).
Topical Anesthesia: Identical protocol to Intervention A (site isolation, drying, and 2% Lidocaine gel application for 2 minutes).
Local Anesthesia Injection: Maxillary buccal infiltration delivered using 4% Articaine with 1:200,000 epinephrine via a sterile short 27-gauge needle, deposited slowly over 60 seconds using identical technique, volume, and rate as Intervention A, but without external vibration or cryotherapy application.
| Study group | Role | What they receive |
|---|---|---|
| Sequence AB (Buzzy® Bee First, Then Conventional) | Experimental | Participants in Sequence AB receive Buzzy® Bee-assisted maxillary buccal infiltration local anesthesia during the first visit (Period 1). After a 1-week washout period, the same participants receive local anesthesia using the conventional administration technique during the second visit (Period 2). Receives: Device: Intervention A: Buzzy® Bee-Assisted Local Anesthesia; Drug: Intervention B: Conventional Local Anesthesia Technique |
| Sequence BA (Conventional First, Then Buzzy® Bee) | Experimental | Participants in Sequence BA receive conventional maxillary buccal infiltration local anesthesia during the first visit (Period 1). After a 1-week washout period, the same participants receive Buzzy® Bee-assisted local anesthesia during the second visit (Period 2). Receives: Device: Intervention A: Buzzy® Bee-Assisted Local Anesthesia; Drug: Intervention B: Conventional Local Anesthesia Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Reported Pain Intensity (Wong-Baker FACES® Pain Rating Scale)
Subjective pain intensity was assessed using the validated Wong-Baker FACES® Pain Rating Scale.
The scale features six facial expressions ranging from 0 ("No Hurt") to 10 ("Hurts Worst") in increments of 2 (0, 2, 4, 6, 8, 10).
Following local anesthesia administration, the child is seated upright and points to the face that best represents their pain intensity experienced during needle insertion.
Higher scores represent higher pain intensity.
Measured: Immediately post-injection (approx. 5 min post-baseline) at Visit 1 (Day 0) and Visit 2 (Day 7)
Secondary outcomes (2)
Physiological Anxiety / Stress Response (Heart Rate)
Physiological stress and anxiety were evaluated continuously via a pediatric pulse oximeter attached to the child's index finger. Heart rate is recorded in beats per minute (BPM) at three standardized procedural milestones:
Baseline: 2 minutes prior to local anesthetic administration while resting in the chair.
During Injection: Exact moment of needle insertion and solution deposition.
Post-Injection: Immediately following needle withdrawal.
Measured: Baseline (2 minutes pre-injection), during injection (approx. 2-3 minutes post-baseline), and post-injection (approx. 5 minutes post-baseline) at Visit 1 (Day 0) and Visit 2 (Day 7).
Behavioral Pain Expression (FLACC Scale)
Objective behavioral pain expression was assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) behavioral pain scale.
Evaluated during the local anesthesia injection procedure by a trained independent observer (physically and via standardized video recording).
Five categories are scored from 0 to 2, yielding a cumulative score ranging from 0 to 10:
0: Relaxed and comfortable
1-3: Mild discomfort
4-6: Moderate pain
7-10: Severe discomfort and/or pain Higher scores represent greater behavioral pain expression.
Measured: During the local anesthesia administration procedure (approx. 2 to 3 minutes post basline) at Visit 1 (Day 0) and Visit 2 (Day 7).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start1 Aug 2025
- Primary completionOct 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaimaa Shaban Mohamed El-desouky, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07886333
- Sponsor's protocol ID
- #P-PED-5-25-3378
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Shilpapriya 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 31338420
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Buzzy Bee Device in Anxiety Reduction and Pain Control During Local Anesthesia Administration
- ClinicalTrials.gov ID
- NCT07886333
- Acronym / sponsor ID
- #P-PED-5-25-3378
- Conditions
- Anesthesia, Anxiety, Pain, Children
- Keywords
- Buzzy Bee Device, local anesthesia, dental anxiety, pain control, crossover
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 21 Oct 2026 (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 present study will evaluate the effectiveness of Buzzy Bee in reducing pain and physiological responses during maxillary buccal infiltration in children aged 5-7 years compared with a conventional injection protocol.
Detailed description
Pain control during local anesthetic administration is essential in pediatric dentistry, as injection-related discomfort may increase anxiety and affect children's cooperation. The present study will evaluate the effectiveness of Buzzy Bee in reducing pain and physiological responses during maxillary buccal infiltration in children aged 5-7 years compared with a conventional injection protocol.
The study includes 40 children attending the Outpatient Clinic of the Pediatric Dentistry Department, Faculty of Dentistry, Tanta University. A randomized crossover design will be used, with each child receiving both interventions during two visits separated by one week. Participants will be randomly allocated to the AB or BA sequence.
Both interventions involved topical application of 4% lidocaine hydrochloride gel for two minutes, followed by maxillary buccal infiltration using 4% articaine with epinephrine 1:200,000. The Buzzy Bee protocol incorporated external cold and vibration, whereas the conventional protocol used audiovisual distraction.
Heart rate will be recorded before, during, and after injection. Pain will be assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) scale and the Wong-Baker Faces Pain Rating Scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence AB (Buzzy® Bee First, Then Conventional) | Experimental | Device: Intervention A: Buzzy® Bee-Assisted Local Anesthesia, Drug: Intervention B: Conventional Local Anesthesia TechniqueParticipants in Sequence AB receive Buzzy® Bee-assisted maxillary buccal infiltration local anesthesia during the first visit (Period 1). After a 1-week washout period, the same participants receive local anesthesia using the conventional administration technique during the second visit (Period 2). |
| Sequence BA (Conventional First, Then Buzzy® Bee) | Experimental | Device: Intervention A: Buzzy® Bee-Assisted Local Anesthesia, Drug: Intervention B: Conventional Local Anesthesia TechniqueParticipants in Sequence BA receive conventional maxillary buccal infiltration local anesthesia during the first visit (Period 1). After a 1-week washout period, the same participants receive Buzzy® Bee-assisted local anesthesia during the second visit (Period 2). |
Who may qualify
- Ages
- 5 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Systemically healthy children classified as ASA-I.
- Children requiring bilateral maxillary buccal infiltration local anesthesia across at least two separate dental treatment appointments.
- Co-operative child with a Frankl behavior rating of 3,4.
- Children free from any neurological or psychological disorder.
Key exclusion criteria (4 listed)
- Children with known allergy to local anesthetic agents.
- Children with developmental delays, intellectual disabilities, or severe uncooperative behavior (Frankl rating 1 or 2).
- Children presenting with acute dental pain, swelling, or active infection at the injection site.
- Parental refusal to provide written informed consent for participation
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 |
|---|---|---|
| Intervention A: Buzzy® Bee-Assisted Local AnesthesiaBehavioral Guidance: Child preparation using the Tell-Show-Do technique. Device Application: The Buzzy® Bee device (equipped with pre-frozen wings) is activated to provide combined high-frequency vibration and cryotherapy. It is placed on the extraoral cheek skin approximately 1-2 cm proximal to the target injection site for 30 seconds prior to needle insertion and remains continuously active throughout needle insertion and solution deposition. Topical Anesthesia: Injection site is isolated with cotton rolls, dried, and treated with 2% Lidocaine gel applied for 2 minutes via a sterile cotton swab. Local Anesthesia Injection: Maxillary buccal infiltration is delivered using 4% Articaine with 1:200,000 epinephrine via a sterile short 27-gauge needle, deposited slowly over 60 seconds while Buzzy® Bee is running. | Device | Sequence AB (Buzzy® Bee First, Then Conventional), Sequence BA (Conventional First, Then Buzzy® Bee) |
| Intervention B: Conventional Local Anesthesia TechniqueBehavioral Guidance: Child preparation using standard Tell-Show-Do behavioral guidance paired with routine audiovisual distraction (cartoons displayed on a chair-side screen). Topical Anesthesia: Identical protocol to Intervention A (site isolation, drying, and 2% Lidocaine gel application for 2 minutes). Local Anesthesia Injection: Maxillary buccal infiltration delivered using 4% Articaine with 1:200,000 epinephrine via a sterile short 27-gauge needle, deposited slowly over 60 seconds using identical technique, volume, and rate as Intervention A, but without external vibration or cryotherapy application. | Drug | Sequence AB (Buzzy® Bee First, Then Conventional), Sequence BA (Conventional First, Then Buzzy® Bee) |
Primary outcome
Self-Reported Pain Intensity (Wong-Baker FACES® Pain Rating Scale)
Time frame: Immediately post-injection (approx. 5 min post-baseline) at Visit 1 (Day 0) and Visit 2 (Day 7)
Subjective pain intensity was assessed using the validated Wong-Baker FACES® Pain Rating Scale. The scale features six facial expressions ranging from 0 ("No Hurt") to 10 ("Hurts Worst") in increments of 2 (0, 2, 4, 6, 8, 10). Following local anesthesia administration, the child is seated upright and points to the face that best represents their pain intensity experienced during needle insertion. Higher scores represent higher pain intensity.
2 secondary outcomes
Physiological Anxiety / Stress Response (Heart Rate)
Time frame: Baseline (2 minutes pre-injection), during injection (approx. 2-3 minutes post-baseline), and post-injection (approx. 5 minutes post-baseline) at Visit 1 (Day 0) and Visit 2 (Day 7).
Behavioral Pain Expression (FLACC Scale)
Time frame: During the local anesthesia administration procedure (approx. 2 to 3 minutes post basline) at Visit 1 (Day 0) and Visit 2 (Day 7).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Results publication: 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.
- Results publication: 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.
Related trials for Anesthesia
Not yet recruitingObservational study
"Comparison of Oxygen Reserve Index (ORI), End-Tidal Oxygen, and Time-Based Preoxygenation Targets With Arterial Blood Gas During Preoxygenation
Preoxygenation Adequacy Assessed by Oxygen Reserve Index, End-tidal Oxygen and Arterial Blood Gas
RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
Not yet recruiting
A Randomized Controlled SaCo-VLM Trial
General Anaesthesia Using Supraglotic Airway
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
RecruitingPhase 4
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention A: Buzzy® Bee-Assisted Local Anesthesia and Intervention B: Conventional Local Anesthesia Technique in people with Anesthesia and Anxiety, run by Tanta 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: looking for participants now, as of the sponsor's last update on 26 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact shaimaa eldesouky, assistant professor (01008994242, shaimaaeldesouky@dent.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-Reported Pain Intensity (Wong-Baker FACES® Pain Rating Scale) (time frame: Immediately post-injection (approx. 5 min post-baseline) at Visit 1 (Day 0) and Visit 2 (Day 7)). 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 NCT07886333, which also lists 2 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 26 Oct 2026.