Effect of External Cold and Vibration (Buzzy Device) Versus the Conventional Technique on Pain Perception During Local Anesthesia Injection in Children.

NCT05067218 | Unknown

• 1 other identifier: Buzzy device in Children.
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Anesthesia; Anesthesia, Local; Vibration

Outcome Measures

Primary Outcomes (1)

• Pain perception during LA injection

  by wong baker scale

  one hour

Secondary Outcomes (1)

• Heart rate during injection of local anesthesia.

  one hour

Other Outcomes (1)

• Child's behavior during local anesthesia injection.

  one hour

Study Arms (2)

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.

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.

Other: Conventinal anasthesia

Interventions

buzzy device DEVICE

bee shaped with wings could be frozen.

buzzy device (intervention)

Conventinal anasthesia OTHER

normal technique of injection

Conventinal anasthesia ( control )

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Children with a behavioral management problem.
• Children with known allergy to local anesthetic agents.
• Parental refusal for participation

Sponsors & Collaborators

• Cairo University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinding of the operator and the patients will not be applicable due to the difference between the used techniques, however, the statistician will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: split mouth

Study Record Dates

• First Submitted: September 22, 2021
• First Posted: October 5, 2021
• Study Start: October 15, 2021
• Primary Completion: October 15, 2022
• Study Completion: November 15, 2022
• Last Updated: October 5, 2021

Record last verified: 2021-09