EFFECT OF BUZZY BEE TO REDUCE PAIN PERECEPTION DURING INFERIOR ALVEOLAR NERVE BLOCK IN CHILDREN - A CROSS OVER STUDY
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BUZZY BEE [ Vibrating device], Conventional technique.
- Who it may be relevant to
- Registry conditions: Pain Management. Basic parameters: 7 years — 9 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Saudi Arabia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Buzzy Bee to Reduce Pain Perception During Inferior Alveolar Nerve Block in Children - A Cross Over Study
Overview
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.
Interventions
- Device BUZZY BEE [ Vibrating device]
already described - Device Conventional technique
described
Primary outcome measures
- SEM [Time frame: During the delivery of anesthesia]
- WBS [Time frame: During the delivery of anesthesia]
- parental scale [Time frame: after administration of anesthesia]
Secondary outcome measures (2)
- PULSE RATE [Time frame: 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 [Time frame: 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]
Eligibility criteria
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 2. Un co-operative child
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Saudi Arabia · 1 center
- College of Dentistry — Jizan
Identifiers
NCT: NCT07324915 · COLLEGE OF DENTISTRY jazan