Effect of a Vibration System on Pain Reduction During Injection of Local Dental Anaesthesia in Children: a Randomized Controlled Clinical Trial
Overview
- Phase
- N/A
- Intervention
- Adminstration Technique using Buzzy external distractor
- Conditions
- Local Anaesthetic
- Sponsor
- Imam Abdulrahman Bin Faisal University
- Enrollment
- 51
- Locations
- 1
- Primary Endpoint
- Self Reported pain intensity: Visual analogue scale (VAS) of pain intensity
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
The study assesses the effect of a new vibration system on pain reduction during the injection of local anesthesia. Children undergoing dental treatment are allocated to two groups; one receiving the Buzz, a vibration system and another group receiving nothing. Pain during injection of local anesthetic is assessed using a validated tool in addition to assessment of child cooperation during treatment.
Detailed Description
Eligibility of children for inclusion into the study will be assessed followed by random sequence generation and randomization into one of the two study group and allocation concealment. Topical anaesthesia will be administered to the two groups followed by implementation of the vibration system in the test group. . Behavior and pain will assessed at the time of injection.
Investigators
Jehan AlHumaid
Associate Professor
Imam Abdulrahman Bin Faisal University
Eligibility Criteria
Inclusion Criteria
- •Children 5-12 years of age.
- •Positive or definitely positive behavior on Frankl scale.6
- •Children receiving treatment on the dental chair.
- •Free from allergies to topical anesthetic used in the study.
- •Parental consent for child participation in the study.
Exclusion Criteria
- •Those in need of treatment under general anesthesia will be excluded from the study.
- •Children with allergies from topical anesthesia
Arms & Interventions
Buzzy
Buzzy was used during Maxillary anesthetic infiltration injection with 2%lidocaine with 1:50,000 epinephrine after topical application with 20% Benzocaine topical gel.
Intervention: Adminstration Technique using Buzzy external distractor
Buzzy
Buzzy was used during Maxillary anesthetic infiltration injection with 2%lidocaine with 1:50,000 epinephrine after topical application with 20% Benzocaine topical gel.
Intervention: Topical Anesthetic
Control
Maxillary anesthetic infiltration injection with 2%lidocaine with 1:50,000 epinephrine after topical application with 20% Benzocaine topical gel only.
Intervention: Topical Anesthetic
Outcomes
Primary Outcomes
Self Reported pain intensity: Visual analogue scale (VAS) of pain intensity
Time Frame: Procedure (immediately after the administration of Dental anesthesia)
Self reported pain intensity before the injection and directly after the injection. Each child scored pain intensity twice, one before the injection and one directly after the injection (0=no pain; 10=Very painful).
Secondary Outcomes
- Parents Perception for the child tolerance of pain; Observational Pain rating scale(Procedure (immediately after the administration of Dental anesthesia.))
- External observation for Facial and Physical expression. Using Sounds, Eyes, and Motor (SEM) scale (RANGE 0-9).(Procedure (immediately during and after the administration of Dental anesthesia.))
- Faces Legs Activity Cry Consolability (FLACC) Scale (RANGE 0-10)(Procedure (immediately during and after the administration of Dental anesthesia.))