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临床试验/NCT06242743
NCT06242743已完成不适用

Effect of Needle Bevel Type on Pain Perception in Children During Inferior Alveolar Nerve Block Anesthesia (a Randomized Controlled Clinical Trial)

Hams Hamed Abdelrahman1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2024年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
66
试验地点
1
主要终点
Subjective pain assessment

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
5 Years 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

结局指标

主要结局

Subjective pain assessment

时间窗: During procedure

Each patient will be trained on using the scale by modeling and then requesting every patient to think of the last time she/he went through a painful experience and to choose the facial expression that best relates his/her current experience of discomfort to the previous one. Facial scales' categories are as follows Score A: Satisfied Score B Indifference Score C: Dissatisfaction

Objective Pain assessment

时间窗: During procedure

Sound, Eye, and Motor scales will be used for pain assessment by viewing the recorded videotapes for the patients during the dental procedure. it assesses changes in comfort level as follows; 1. Comfort 2. Mild discomfort 3. Moderate discomfort 4. Severe discomfort higher scores mean higher discomfort Minimum score: 1 Maximum score: 12

次要结局

  • Needle deformation(During procedure)

研究者

发起方
Hams Hamed Abdelrahman
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Hams Hamed Abdelrahman

Assistant lecturer of DPH and Clinical statistician

Alexandria University

研究点 (1)

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