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Type of Needle Bevel on Pain Perception in Children During Inferior Alveolar Nerve Block Anesthesia - Trial NCT06242743

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NCT06242743
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Trial Details
ClinicalTrials.gov โ€ข NCT06242743
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Type of Needle Bevel on Pain Perception in Children During Inferior Alveolar Nerve Block Anesthesia
Effect of Needle Bevel Type on Pain Perception in Children During Inferior Alveolar Nerve Block Anesthesia (a Randomized Controlled Clinical Trial)

Study Focus

Anesthesia, Local

Scalpel blade needles

Interventional

other

Sponsor & Location

Hams Hamed Abdelrahman

Alexandria University

Alexandria, Egypt

Timeline & Enrollment

N/A

Jan 01, 2024

Jan 30, 2024

66 participants

Primary Outcome

Objective Pain assessment,Subjective pain assessment

Summary

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.

ICD-10 Classifications

Local anaesthetics
Anaesthetic, unspecified
Other and unspecified general anaesthetics
Poisoning: Local anaesthetics
Parenteral anaesthetics

Data Source

ClinicalTrials.gov

NCT06242743

Non-Device Trial