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

NCT05338983 | Unknown

• 1 other identifier: Dental local anesthesia pain
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Local Anesthetics; Epinephrine; Vibration

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (4)

Control: Traditional local anesthesia

ACTIVE COMPARATOR

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; Drug: Mepivacaine Hydrochloride

Group A (Warm group)

EXPERIMENTAL

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; Device: Avent baby bottle warmer; Drug: Mepivacaine Hydrochloride

Group B (Buffered group)

EXPERIMENTAL

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; Drug: Sodium bicarbonate; Drug: Mepivacaine Hydrochloride

Group C (Buzzy group)

EXPERIMENTAL

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; Device: Buzzy device; Drug: Mepivacaine Hydrochloride

Interventions

Topical anesthetic DRUG

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

Control: Traditional local anesthesia; Group A (Warm group); Group B (Buffered group); Group C (Buzzy group)

Avent baby bottle warmer DEVICE

Warming device

Group A (Warm group)

Sodium bicarbonate 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.

Group B (Buffered group)

Buzzy device 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.

Group C (Buzzy group)

Mepivacaine Hydrochloride DRUG

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

Control: Traditional local anesthesia; Group A (Warm group); Group B (Buffered group); Group C (Buzzy group)

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Faculty of Dentistry

Al Mansurah, 35511, Egypt

Location

Related Publications (4)

• 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.

  PMID: 17567343 BACKGROUND

• 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.

  PMID: 21406147 BACKGROUND

• 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.

  PMID: 12212876 BACKGROUND

• 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.

  PMID: 29503582 BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Anesthetics, Local; Sodium Bicarbonate; Mepivacaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses; Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Sahar H Zidan

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

  PRINCIPAL INVESTIGATOR

• Nadia M Farrag

  Professor of Pediatric Dentistry Faculty of Dentistry, Mansoura University

  STUDY DIRECTOR

• Ahmed H Wahba

  Lecturer of Pediatric Dentistry Faculty of Dentistry Mansoura University

  STUDY DIRECTOR

Central Study Contacts

Sahar H Zidan

CONTACT

020122217467; szidan750@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The observer and the recipients will be blinded to the study group to avoid bias (double blind randomized controlled trial)
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: April 14, 2022
• First Posted: April 21, 2022
• Study Start: May 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: June 1, 2023
• Last Updated: April 29, 2022

Record last verified: 2022-04

Locations

EG (1)