Effect of External Cold and Vibration (Buzzy Device) Versus the Conventional Technique on Pain Perception During Local Anesthesia Injection in Children.
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Cairo University
- Enrollment
- 12
- Primary Endpoint
- Pain perception during LA injection
Study Overview
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).
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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
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.
Eligibility Criteria
- Ages
- 6 Years to 11 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
Exclusion Criteria
- •Children with a behavioral management problem.
- •Children with known allergy to local anesthetic agents.
- •Parental refusal for participation
Outcomes
Primary Outcomes
Pain perception during LA injection
Time Frame: one hour
by wong baker scale
Secondary Outcomes
- Heart rate during injection of local anesthesia.(one hour)
Investigators
Mai Gamal Eldeen Hassan Sabra
principal investigator
Cairo University