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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| topical anesthesia | Active Comparator | Topical anesthetic gels are applied prior to injection at the injection site to minimize pain upon insertion of the needle during local anesthesia |
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| vibration | Experimental | Vibration using a vibrating devise (Buzzy) can help reduce the pain during local anesthesia injection. It is placed extra-orally before and during needle insertion |
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| cold pack | Experimental | Cold pack provided with the Buzzy device will be used without the vibration mode of the device. It is applied extra-orally before and during needle insertion. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| topical anesthetic gel | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pain perception during needle insertion in different anesthetic techniques Using SEM scale | 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. | during the procedure (needle insertion) |
| Measure | Description | Time Frame |
|---|---|---|
| Pain will be assessed after local anesthesia injection by means of Visual analogue scale. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dina A Sharaf, PhD | Contact | 01005319290 | 002 | dina.sharaf@alexu.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry- Alexandria University | Recruiting | Alexandria | 21511 | Egypt |
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| ID | Term |
|---|---|
| D014732 | Vibration |
| ID | Term |
|---|---|
| D055595 | Mechanical Phenomena |
| D055585 | Physical Phenomena |
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| Vibration | Other | 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. |
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| Cold pack | Other | 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. |
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| immediately after the procedure (needle insertion) |