Pain, Local Anesthetics, Epinephrine, Vibration
Conditions
Brief summary
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
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).
Interventions
20% Benzocaine gel will be applied on the area of infiltration
DEVICEAvent baby bottle warmer
Warming device
DRUGSodium bicarbonate
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.
DEVICEBuzzy device
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.
Mepivacaine HCL 2% with Epinephrine 1:100,000 Local Anesthetic. Local Dental anesthetic infiltration
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Masking description
The observer and the recipients will be blinded to the study group to avoid bias (double blind randomized controlled trial)
Intervention 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).
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
Yes
Inclusion criteria
1. Children requiring maxillary infiltration LA for dental treatment. 2. Cooperative children (positive or definitely positive on Frankel's scale). 3. Children are in apparently good health and not taking any medications that will alter their pain perception. 4. Children have no history of allergy to Mepivacaine
Exclusion criteria
1. The person responsible does not authorize the participation of the child as a research volunteer. 2. Be using pain modulating drugs. 3. Patients with a history of hypersensitivity to local anesthetics. 4. Patients with a history of systemic diseases.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Behavoir | During the anesthetic procedure | 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. |
| Self-perception of pain | Immediately after anesthesia | 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 |
Countries
Egypt
Contacts
Primary ContactSahar H Zidan
Outcome results
None listed