Effect of Different Approaches of Delivering Local Dental Anesthesia on Pain Perception in Children.

Study Overview
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Brief Summary
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The aim of the study is to compare the efficacy of three different approaches of local anesthesia (LA) administration (Warm[37°C] LA, Buffered LA, and BUZZY device) on pain perception to young children ( 6-12 years old) using sound -eye -motor and Wong-Baker FPR scales.

Detailed Description
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Pain is an unpleasant sensory and emotional experience associated with actual or potential tissue damage.In pediatric dentistry, the injection of local anesthesia is the most common cause of fear and expected to be painful.So, an effective pain control significantly contributes to an optimal dental treatment in pediatric dentistry.Proper pain prevention may enhance the child's cooperation by building dentist-child trust and reducing fear and/or anxiety during the current or future visit(s). The purpose of this study is to compare the efficacy of three different approaches of LA administration(Warm[37°C] LA, Buffered LA, and BUZZY device) on pain perception to young children ( 6-12 years old) using sound -eye -motor and Wong-Baker FPR scales. This study will be conducted on 80 children aged between 6-12 years from pediatric dental clinic, Faculty of Dentistry, Mansoura University. Children will be divided to 4 equal groups, 20 children each. Three experimental groups, and a (control group) . The 4 groups will be randomly allocated for each technique using block technique of simple random sampling .Randomized block designs are constructed to reduce noise or variance in the data. Every block will include the equal number of the four groups (three experimental and one control).

Official Title
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Effect of Different Approaches of Delivering Local Dental Anesthesia on Pain Perception in Children. A Double Blinded Randomized Controlled Clinical Trial.

Conditions
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Pain, Local Anesthetics, Epinephrine, Vibration

Intervention / Treatment
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* Drug: Topical anesthetic
* Device: Avent baby bottle warmer
* Drug: Sodium bicarbonate
* Device: Buzzy device
* Drug: Mepivacaine Hydrochloride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children requiring maxillary infiltration LA for dental treatment. Cooperative children (positive or definitely positive on Frankel's scale). Children are in apparently good health and not taking any medications that will alter their pain perception. Children have no history of allergy to Mepivacaine Exclusion Criteria: The person responsible does not authorize the participation of the child as a research volunteer. Be using pain modulating drugs. Patients with a history of hypersensitivity to local anesthetics. Patients with a history of systemic diseases.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Children will be divided into 4 equal groups, 20 children each. Three experimental groups, and a(control group) . The 4 groups will be randomly allocated for each technique using block technique of simple random sampling. Randomized block designs are constructed to reduce noise or variance in the data. Every block will include the equal number of the four groups (three experimental and one control).
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control: Traditional local anesthesia<br>After proper isolation and drying of the injection site, the topical anesthetic gel (20% benzocaine) will be applied to the injection site using sterile cotton tipped applicator for 60 seconds, then the anesthesia (2% mepivacaine hcl with 1:100000 epinephrine) will be administere | Drug: Topical anesthetic<br>* 20% Benzocaine gel will be applied on the area of infiltration<br>Drug: Mepivacaine Hydrochloride<br>* Mepivacaine HCL 2% with Epinephrine 1:100,000 Local Anesthetic. Local Dental anesthetic infiltration<br>|
| Experimental: Group A (Warm group)<br>The topical anesthetic gel (20% benzocaine) will be applied to the injection site using sterile cotton tipped applicator for 60 seconds. The cartridge of anesthetic solution will be placed in the baby bottle warmer in 300 ml of cold water (21°C). The anesthetic fluid will be warmed to reach 37°C (98.6°F) ,then the local anesthesia((2% mepivacaine hcl with 1:100000 epinephrine) will be administered | Drug: Topical anesthetic<br>* 20% Benzocaine gel will be applied on the area of infiltration<br>Device: Avent baby bottle warmer<br>* Warming device<br>Drug: Mepivacaine Hydrochloride<br>* Mepivacaine HCL 2% with Epinephrine 1:100,000 Local Anesthetic. Local Dental anesthetic infiltration<br>|
| Experimental: Group B (Buffered group)<br>The topical anesthetic gel (20% benzocaine) will be applied to the injection site for 60 seconds,0.1ml of 8.4% of sodium bicarbonate will be removed from the 50 ml vial by one ml insulin syringe and directly injected into the local anesthetic cartridge. The cartridge will be shacked 5 times to mix the solution, then the local anesthesia(2% mepivacaine hcl with 1:100000 epinephrine) will be administered. | Drug: Topical anesthetic<br>* 20% Benzocaine gel will be applied on the area of infiltration<br>Drug: Sodium bicarbonate<br>* 0.1ml of 8.4% of sodium bicarbonate will be removed from the 50ml vial by one ml insulin syringe , directly injected into the local anesthetic cartridge and will be shacked 5 times to mix the solution.<br>Drug: Mepivacaine Hydrochloride<br>* Mepivacaine HCL 2% with Epinephrine 1:100,000 Local Anesthetic. Local Dental anesthetic infiltration<br>|
| Experimental: Group C (Buzzy group)<br>After the child setting on the dental chair,(20% benzocaine) topical anesthetic gel will be applied to the injection site for 60 seconds. He will be familiar with the Buzzy device by explaining how it works in simple words. The wings of the device will be kept in the freezer. Once the child is ready, the frozen wings will be attached to the device and Buzzy will be placed extra-orally above the area/cheek where local anesthetic will be delivered. Once Buzzy is being held in place by hand, press the button or switch on the top of Buzzy, then the anesthesia (2% mepivacaine hcl with 1:100000 epinephrine) will be administered. | Drug: Topical anesthetic<br>* 20% Benzocaine gel will be applied on the area of infiltration<br>Device: Buzzy device<br>* Bee-shaped apparatus consisting of two parts: the main vibrating body of a bee and detachable ice wings. External application of Buzzy device during administration of dental anesthetic.<br>Drug: Mepivacaine Hydrochloride<br>* Mepivacaine HCL 2% with Epinephrine 1:100,000 Local Anesthetic. Local Dental anesthetic infiltration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Behavoir | The pain will be analyzed by sound ,eye motor scale An assistant will be trained to measure and calibrate the SEM scale. The assistant will be blinded to the study group to avoid bias. | During the anesthetic procedure | 
| Self-perception of pain | The pain will be analyzed by the Wong Baker Faces scales . A set of six cartoon faces will be shown to the child with varying facial expressions ranging from a very smiling face to a very sad face. A brief explanation will be given to the child about each face after which the child will be instructed to choose the face that will describe his/ her feelings while receiving local anesthesia | Immediately after anesthesia |