Effect of Buzzy Bee to Reduce Pain Perception During Inferior Alveolar Nerve Block in Children - A Cross Over Study
Overview
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- University of Jazan
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- SEM
Overview
Brief Summary
Pain management during invasive dental procedures is crucial to avoid noncompliance and treatment avoidance. Thus, measures to reduce injection discomfort are needed to prevent patients from avoiding dental treatment. Tooth extractions, and invasive dental procedures cause pain. Local anesthetics are one of the most effective and safest pain relievers. Even though many children have needle fear, anesthetic may still be uncomfortable. Fear of pain, especially in young children, is real since it affects health outcomes. Anxiety and fear may delay dental treatment and harm the patient's oral health. Distraction, topical anesthetic gel, modifying infiltration rate, intra-oral vibrating devices, computerized delivery systems, pre-cooling injection site, and other pharmacological, physical, and psychological interventions have all been proposed as potential pain relievers. An example of this kind of system One approach that combines an extraoral cold with a vibrating device is Buzzy Bee.
Detailed Description
Before start of the study a written informed consent will be obtained from each parent of the children included in the study stating they accepted the treatment. The study will be performed among children aged 7 to 9 years and who required inferior alveolar block for their treatment. Children who needed anaesthesia for dental treatment will be randomly divided into two groups Group A and Group B using a lottery randomization technique. control group: the children in this group will be delivered Inferior alveolar nerve block in a conventional way [1 min of topical anaesthesia and local infiltration] Experimental group: A Buzzy external cold and vibrating device will be used on the site of application [right/left face] 2 minutes before anaesthesia and this application will be maintained throughout the injection.
At the first visit, the children in Group A will receive the control intervention and those in group B will receive the experimental intervention. A wash out period of 7 days was observed, after which the second visit will be scheduled. At the second visit, the children in Group A will receive the experimental intervention and Group B will receive the control intervention. Demographic details, informed consent from the parents, and assent from the children will be obtained before the commencement of the study. Outcomes will be recorded as primary and secondary outcomes. primary outcomes includes FLACC, WBS and parental scale where as secondary outcomes will be pulse rate and Frankel behaviour rating scale.
Pulse rate will be recorded before anaesthesia, during anaesthesia and 1 min after delivery of anaesthesia, Frankel behaviour rating scale will be measured before, during and after anaesthesia procedures. FLACC and WBS scales will be used to objectively and subjectively record the pain perception. parental scale will be used to determine parental view regarding pain scale during anaesthesia procedure.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 7 Years to 9 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy children with no systemic illness, allergies
- •Co-operative child
- •Patient requiring block for dental treatment
- •children with proper parental consent
Exclusion Criteria
- •1\. Children with systemic illness and allergy
- •Un co-operative child
Arms & Interventions
BUZZY BEE
Vibrating device
Intervention: BUZZY BEE [ Vibrating device] (Device)
Conventional technique
conventional way
Intervention: Conventional technique (Device)
Outcomes
Primary Outcomes
SEM
Time Frame: During the delivery of anesthesia
Sound, Eye, Motor
WBS
Time Frame: During the delivery of anesthesia
WONG BAKER SCALE
parental scale
Time Frame: after administration of anesthesia
PARENTAL SCALE
Secondary Outcomes
- PULSE RATE(Measured three times. 15 minutes before the delivery of anesthesia, b. At the time of delivery of anesthesia and c. 1 minute after the delivery of anesthesia)
- BEHAVIOURAL RATING SCALE(Measured three times. 15 minutes before the delivery of anesthesia, b. At the time of delivery of anesthesia and c. 1 minute after the delivery of anesthesia)
Investigators
satish vishwanathaiah
Associate professor
University of Jazan