AnesthesiaNCT05067218
Effect of External Cold and Vibration (Buzzy Device) Versus the Conventional Technique on Pain Perception During Local Anesthesia Injection in Children.
A study testing buzzy device and Conventinal anasthesia in people with Anesthesia and Anesthesia, Local, run by Cairo University.
Trial summary
This study adopts the null hypothesis (There is no difference in pain perception during local anesthesia injection with the buzzy device in comparison to the conventional technique). Read more about this study
- Who is it for?
- Ages 6 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Anesthesia, Local, Vibration
- What is being tested?
- buzzy device and Conventinal anasthesia
- 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
- 12 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2021to 15 Nov 2022
- 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 11 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.
- Medically fit children (ASA I, II).
- Children mentally capable of communication.
- Children aged 6-11 years.
- First dental visit.
- Patient requiring inferior alveolar nerve block local anesthesia injection for dental treatment.
Who cannot join
- Children with a behavioral management problem.
- Children with known allergy to local anesthetic agents.
- Parental refusal for participation
About this study
This study adopts the null hypothesis (There is no difference in pain perception during local anesthesia injection with the buzzy device in comparison to the conventional technique).
Read the detailed description
The injection of local anesthesia in children is usually associated with fear, anxiety, and discomfort. There is an essential need to develop techniques that decrease pain during injection, preventing patients from avoiding dental treatment.The efficacy of a child-friendly device, having a combined effect of vibration and distraction, with the conventional method of injection on pain, anxiety, and behavior of pediatric patients. The evaluation the pain perception and comfort of the patient during local anesthesia delivery using the Buzzy device and conventional syringe and revealed that the external cold and vibration via Buzzy can reduce pain and anxiety during local anesthetic delivery for various dental procedures.
- Conditions
- Anesthesia, Anesthesia, Local, Vibration
- Being tested
- buzzy device, Conventinal anasthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
buzzy deviceDevice
bee shaped with wings could be frozen.
Conventinal anasthesiaOther
normal technique of injection
| Study group | Role | What they receive |
|---|---|---|
| buzzy device (intervention) | Active comparator | The wings of buzzy device will be kept frozen and once the child is ready, the frozen wing will be attached to the device and Buzzy will be placed extra-orally above the area/cheek where local anesthetic is to be delivered. Receives: Device: buzzy device |
| Conventinal anasthesia ( control ) | Experimental | * The site of injection will be dried then topical anesthetic gel of 20% benzocaine (Dharma Ophal-S) will be applied. The duration of application of gel will be 1 minute.
* Local anesthetic solution will be delivered using a standard aspirating syringe with 27-gauge, 21 mm short needles. Receives: Other: Conventinal anasthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain perception during LA injection
by wong baker scale
Measured: one hour
Secondary outcomes (1)
Heart rate during injection of local anesthesia.
pulse oximeter
Measured: one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2021
- Study start15 Oct 2021 (estimated)
- Primary completion15 Oct 2022 (estimated)
- Study completion15 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies 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
- Model description
- split mouth
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Gamal Eldeen Hassan Sabra, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05067218
- Sponsor's protocol ID
- Buzzy device in Children.
- Status last verified
- Sep 2021
- First submitted
- 22 Sep 2021
- Last updated
- 5 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of External Cold and Vibration (Buzzy Device) Versus the Conventional Technique on Pain Perception During Local Anesthesia Injection in Children.
- ClinicalTrials.gov ID
- NCT05067218
- Acronym / sponsor ID
- Buzzy device in Children.
- Conditions
- Anesthesia, Anesthesia, Local, Vibration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Oct 2021 (estimated)
- Primary completion
- 15 Oct 2022 (estimated)
- Study completion
- 15 Nov 2022 (estimated)
- First posted
- 5 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.
This study adopts the null hypothesis (There is no difference in pain perception during local anesthesia injection with the buzzy device in comparison to the conventional technique).
Detailed description
The injection of local anesthesia in children is usually associated with fear, anxiety, and discomfort. There is an essential need to develop techniques that decrease pain during injection, preventing patients from avoiding dental treatment.The efficacy of a child-friendly device, having a combined effect of vibration and distraction, with the conventional method of injection on pain, anxiety, and behavior of pediatric patients. The evaluation the pain perception and comfort of the patient during local anesthesia delivery using the Buzzy device and conventional syringe and revealed that the external cold and vibration via Buzzy can reduce pain and anxiety during local anesthetic delivery for various dental procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- split mouth
| Arm | Type | Receives |
|---|---|---|
| buzzy device (intervention) | Active comparator | Device: buzzy deviceThe wings of buzzy device will be kept frozen and once the child is ready, the frozen wing will be attached to the device and Buzzy will be placed extra-orally above the area/cheek where local anesthetic is to be delivered. |
| Conventinal anasthesia ( control ) | Experimental | Other: Conventinal anasthesia* The site of injection will be dried then topical anesthetic gel of 20% benzocaine (Dharma Ophal-S) will be applied. The duration of application of gel will be 1 minute. * Local anesthetic solution will be delivered using a standard aspirating syringe with 27-gauge, 21 mm short needles. |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children classified as cooperative or potentially cooperative according to Wright's classification of child behaviour.
- Medically fit children (ASA I, II).
- Children mentally capable of communication.
- Children aged 6-11 years.
- First dental visit.
Key exclusion criteria (3 listed)
- Children with a behavioral management problem.
- Children with known allergy to local anesthetic agents.
- Parental refusal 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 |
|---|---|---|
| buzzy devicebee shaped with wings could be frozen. | Device | buzzy device (intervention) |
| Conventinal anasthesianormal technique of injection | Other | Conventinal anasthesia ( control ) |
Primary outcome
Pain perception during LA injection
Time frame: one hour
by wong baker scale
1 secondary outcome
Heart rate during injection of local anesthesia.
Time frame: one hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2021.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing buzzy device and Conventinal anasthesia in people with Anesthesia and Anesthesia, Local, run by Cairo University.
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 6 inclusion and 3 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 5 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
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 LA injection (time frame: one hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Oct 2021.