Type of Needle Bevel on Pain Perception in Children During Inferior Alveolar Nerve Block Anesthesia

Hams Hamed Abdelrahman

Status

Enrolling

Conditions

Anesthesia, Local

Treatments

Other: Scalpel blade needles

Other: standard blade needles

Study type

Interventional

Funder types

Other

Identifiers

NCT06242743

0726_07/2023

Details and patient eligibility

About

fear of the discomfort that comes with anesthetic needle insertion. For dental local anesthesia, needles with a scalpel-designed bevel have been claimed to decrease pain elicited by injection.

Objective of the study: The purpose of this study is to assess the effect of needle bevel on patient's perception of pain during inferior alveolar nerve block anesthesia and the needle tip will be further assessed for deformation.

Materials and Methods: The study will be a double-blind randomized controlled clinical trial, with a parallel design. A total of sixty-six healthy children will be selected from The Pediatric Dentistry and Dental Public Health Clinic, Faculty of Dentistry, Alexandria University, Egypt. Children will be selected with scores 3 or 4 Frankel behavioral rating scale. Written consent will be obtained from the legal guardian. Participants will be randomly allocated into two groups according to the type of needle bevel that will be used. Group I (test group) will receive inferior alveolar nerve block (IANB) using a double scalpel blade bevel needle, while group II (control group) will receive IANB using a standard blade bevel needle. All the procedures will be videotaped. Pain reaction will be evaluated subjectively using a face scale modified from the Maunuksela scale and objectively using the Sensory, Eye, and Motor (SEM) scale. After the respective single injection, the needles will be fixed on an object slide and prepared for microscopic examination.

Enrollment

66 estimated patients

Sex

All

Ages

5 to 7 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Healthy children with ASA I, II Classification.
Children with no learning disabilities.
Positive or definitely positive behavior according to the Frankl Scale.
Patient requiring local anesthetic injection IANB for dental treatment.
Written consent of the legal guardian.

Exclusion criteria

Medically compromised patient.
Children with emergency treatment needs, such as abscess, cellulitis and space infection.
Hypersensitivity to local anesthetic drugs