Effectiveness of Vibratory Versus Cold Stimuli on Pain Perception in Children
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: topical anesthetic gel, Vibration, Cold pack.
- Who it may be relevant to
- Registry conditions: Pain Perception. Basic parameters: 5 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
- Egypt
- 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
Effectiveness of Vibratory Versus Cold Stimuli on Pain Perception During Needle Insertion in Children
Overview
Local anesthesia is an anxiety-provoking procedure. Pain control is important for effective behavior guidance, specially among pediatric patients. This study aims to evaluate the effectiveness of Buzzy® as a topical anesthetic in pain perception through two ways: once using vibration mode without the cold pack and the other using the cold pack without vibration and comparing it to topical anesthetic gel during different anesthetic techniques Methods: A randomized controlled clinical trial involving 72 healthy cooperative patients aged 5-9 years. They will be allocated to receive local anesthesia either using the vibration mode of Buzzy Bee (test group) or the cold pack of Buzzy Bee (test group) or conventional topical anesthetic gel (control group). Pain response will be assessed using Visual Analog Scale (VAS) and SEM scale.
Interventions
- Other topical anesthetic gel
gels applied directly to the mucous membranes to provide localized relief of pain by numbing the area. They typically contain active ingredients such as lidocaine, benzocaine, or prilocaine, which work by blocking nerve signals to reduce sensation and discomfort - Other Vibration
The vibration generated by the Buzzy device functions as a non-pharmacological agent that can reduce pain perception in children based on the principles of the Gate Control Theory of Pain. - Other Cold pack
cold packs are also provided by the Buzzy device. they act as non-pharmacological agents that can reduce pain perception in children based on the Gate Control Theory of Pain.
Primary outcome measures
- Pain perception during needle insertion in different anesthetic techniques Using SEM scale [Time frame: during the procedure (needle insertion)]
Secondary outcome measures (1)
- Pain will be assessed after local anesthesia injection by means of Visual analogue scale. [Time frame: immediately after the procedure (needle insertion)]
Eligibility criteria
Inclusion criteria
- Patients indicated for simple restorative procedures.
- Children with physical status ASA I, II.
- Children with no learning disabilities
- Positive or definitely positive behavior during preoperative assessments according to the Frankl Scale.
- Patients whom parents will give consent to participate
Exclusion criteria
- Patients allergic to local anesthesia or having a family history of allergy to local anesthesia.
- Patients with acute oral or facial infection (swelling and/or cellulites)
- Having active sites of pathosis in the area of injection that could affect anesthetic assessment.
- Children with special health care needs.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
Egypt · 1 center
- Faculty of Dentistry- Alexandria University — Alexandria
Identifiers
NCT: NCT06841601 · 0568-12/22