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

Mansoura University

Status: Unknown

Conditions: Local Anesthetics; Vibration; Epinephrine; Pain

Treatments: Drug: Mepivacaine Hydrochloride; Device: Buzzy device; Drug: Sodium bicarbonate; Drug: Topical anesthetic; Device: Avent baby bottle warmer

Study type: Interventional

Funder types: Other

Identifiers

NCT05338983

Dental local anesthesia pain

Details and patient eligibility

About

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.

Full 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).

Enrollment: 80 estimated patients

Sex: All

Ages: 6 to 12 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 4 patient groups

Control: Traditional local anesthesia

Active Comparator group

Description:

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

Treatment:

Drug: Topical anesthetic

Drug: Mepivacaine Hydrochloride

Group A (Warm group)

Experimental group

Description:

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

Treatment:

Device: Avent baby bottle warmer

Drug: Topical anesthetic

Drug: Mepivacaine Hydrochloride

Group B (Buffered group)

Experimental group

Description:

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.

Treatment:

Drug: Sodium bicarbonate

Drug: Topical anesthetic

Drug: Mepivacaine Hydrochloride

Group C (Buzzy group)

Experimental group

Description:

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.

Treatment:

Device: Buzzy device

Drug: Topical anesthetic

Drug: Mepivacaine Hydrochloride