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
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 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 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 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.
- 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
- 21 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