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

NCT ID: NCT05338983

Last Updated: 2022-04-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2023-06-01

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).

Conditions

Pain; Local Anesthetics; Epinephrine; Vibration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Control: Traditional local anesthesia

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 Type: ACTIVE_COMPARATOR

Topical anesthetic

Intervention Type: DRUG

20% Benzocaine gel will be applied on the area of infiltration

Mepivacaine Hydrochloride

Intervention Type: DRUG

Mepivacaine HCL 2% with Epinephrine 1:100,000 Local Anesthetic. Local Dental anesthetic infiltration

Group A (Warm group)

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 Type: EXPERIMENTAL

Topical anesthetic

Intervention Type: DRUG

20% Benzocaine gel will be applied on the area of infiltration

Avent baby bottle warmer

Intervention Type: DEVICE

Warming device

Mepivacaine Hydrochloride

Intervention Type: DRUG

Mepivacaine HCL 2% with Epinephrine 1:100,000 Local Anesthetic. Local Dental anesthetic infiltration

Group B (Buffered group)

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 Type: EXPERIMENTAL

Topical anesthetic

Intervention Type: DRUG

20% Benzocaine gel will be applied on the area of infiltration

Sodium bicarbonate

Intervention Type: DRUG

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.

Mepivacaine Hydrochloride

Intervention Type: DRUG

Mepivacaine HCL 2% with Epinephrine 1:100,000 Local Anesthetic. Local Dental anesthetic infiltration

Group C (Buzzy group)

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 Type: EXPERIMENTAL

Topical anesthetic

Intervention Type: DRUG

20% Benzocaine gel will be applied on the area of infiltration

Buzzy device

Intervention Type: 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 Hydrochloride

Intervention Type: DRUG

Mepivacaine HCL 2% with Epinephrine 1:100,000 Local Anesthetic. Local Dental anesthetic infiltration

Interventions

Topical anesthetic

20% Benzocaine gel will be applied on the area of infiltration

Intervention Type: DRUG

Avent baby bottle warmer

Warming device

Intervention Type: DEVICE

Sodium 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.

Intervention Type: DRUG

Buzzy 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.

Intervention Type: DEVICE

Mepivacaine Hydrochloride

Mepivacaine HCL 2% with Epinephrine 1:100,000 Local Anesthetic. Local Dental anesthetic infiltration

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sahar H Zidan

Role: PRINCIPAL_INVESTIGATOR

Dentist at Ministry of Health B.D.S (2013), Diploma (2016)

Nadia M Farrag

Role: STUDY_DIRECTOR

Professor of Pediatric Dentistry Faculty of Dentistry, Mansoura University

Ahmed H Wahba

Role: STUDY_DIRECTOR

Lecturer of Pediatric Dentistry Faculty of Dentistry Mansoura University

Locations

Faculty of Dentistry

Al Mansurah, , Egypt

Countries

Egypt

Central Contacts

Sahar H Zidan

Role: CONTACT

szidan750@gmail.com

020122217467

References

Leff DR, Nortley M, Dang V, Bhutiani RP. The effect of local cooling on pain perception during infiltration of local anaesthetic agents, a prospective randomised controlled trial. Anaesthesia. 2007 Jul;62(7):677-82. doi: 10.1111/j.1365-2044.2007.05056.x.

Reference Type: BACKGROUND

PMID: 17567343 (View on PubMed)

Roeber B, Wallace DP, Rothe V, Salama F, Allen KD. Evaluation of the effects of the VibraJect attachment on pain in children receiving local anesthesia. Pediatr Dent. 2011 Jan-Feb;33(1):46-50.

Reference Type: BACKGROUND

PMID: 21406147 (View on PubMed)

Ram D, Hermida LB, Peretz B. A comparison of warmed and room-temperature anesthetic for local anesthesia in children. Pediatr Dent. 2002 Jul-Aug;24(4):333-6.

Reference Type: BACKGROUND

PMID: 12212876 (View on PubMed)

Aravena PC, Barrientos C, Troncoso C, Coronado C, Sotelo-Hitschfeld P. Effect of warming anesthetic on pain perception during dental injection: a split-mouth randomized clinical trial. Local Reg Anesth. 2018 Feb 22;11:9-13. doi: 10.2147/LRA.S147288. eCollection 2018.

Reference Type: BACKGROUND

PMID: 29503582 (View on PubMed)

Other Identifiers

Dental local anesthesia pain

Identifier Type: -

Identifier Source: org_study_id