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

Not Applicable

• Conditions: Pain; Vibration; Local Anesthetics; Epinephrine
• Interventions: Drug: Topical anesthetic; Drug: Mepivacaine Hydrochloride; Device: Avent baby bottle warmer; Device: Buzzy device; Drug: Sodium bicarbonate

• Registration Number: NCT05338983
• Lead Sponsor: Mansoura University

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).

Study Timeline

• Status Verified: 2022-04
• Study First Submitted: 2022-04-14
• Study First Submitted QC: 2022-04-14
• Study First Posted: 2022-04-21
• Last Update Submitted: 2022-04-25
• Last Update Posted: 2022-04-29
• Study Start: 2022-05-01
• Primary Completion: 2023-05-01
• Study Completion: 2023-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control: Traditional local anesthesia	Topical anesthetic	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
Control: Traditional local anesthesia	Mepivacaine Hydrochloride	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
Group A (Warm group)	Topical anesthetic	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
Group A (Warm group)	Avent baby bottle warmer	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
Group A (Warm group)	Mepivacaine Hydrochloride	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
Group B (Buffered group)	Topical anesthetic	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.
Group B (Buffered group)	Mepivacaine Hydrochloride	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.
Group C (Buzzy group)	Topical anesthetic	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.
Group C (Buzzy group)	Buzzy device	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.
Group C (Buzzy group)	Mepivacaine Hydrochloride	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.
Group B (Buffered group)	Sodium bicarbonate	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.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Faculty of Dentistry; 🇪🇬 Mansoura, Egypt