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

Pain Clinical Trial

Official title:

Effect of Different Approaches of Delivering Local Dental Anesthesia on Pain Perception in Children. A Double Blinded Randomized Controlled Clinical Trial.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05338983
• Other study ID #: Dental local anesthesia pain
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: June 1, 2023

Study information

• Verified date: April 2022
• Source: Mansoura University
• Contact: Sahar H Zidan
• Phone: 020122217467
• Email: szidan750[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: June 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Epinephrine
• Local Anesthetics
• Pain
• Vibration

Intervention

Drug:
• Topical anesthetic
20% Benzocaine gel will be applied on the area of infiltration

Device:
• Avent baby bottle warmer
Warming device

Drug:
• 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.

Device:
• 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.

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

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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