Pain Perception
Conditions
Brief summary
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
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
OTHERVibration
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.
OTHERCold 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.
Sponsors
Alexandria University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 9 Years
Healthy volunteers
No
Inclusion criteria
1. Patients indicated for simple restorative procedures. 2. Children with physical status ASA I, II. 3. Children with no learning disabilities 4. Positive or definitely positive behavior during preoperative assessments according to the Frankl Scale. 5. Patients whom parents will give consent to participate
Exclusion criteria
1. Patients allergic to local anesthesia or having a family history of allergy to local anesthesia. 2. Patients with acute oral or facial infection (swelling and/or cellulites) 3. Having active sites of pathosis in the area of injection that could affect anesthetic assessment. 4. Children with special health care needs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain perception during needle insertion in different anesthetic techniques Using SEM scale | during the procedure (needle insertion) | Objective method of pain assessment using SEM (sound, eye and movement scale). It is a behavioral assessment tool to evaluate pain and distress responses in children during dental procedures. It uses scores from 0 till 3 according to increasing levels of distress. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain will be assessed after local anesthesia injection by means of Visual analogue scale. | immediately after the procedure (needle insertion) | Subjective method of pain assessment where patients will be instructed how to point to the position on the line between faces to indicate how much pain they felt during local anesthesia administration. The total scores range from 0 to 10. Happy to sad faces are connected to the line, with a higher score indicating more severe pain |
Countries
Egypt
Contacts
Primary ContactDina A Sharaf, PhD
Outcome results
None listed