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临床试验/CTRI/2025/07/091562
CTRI/2025/07/091562尚未招募不适用

Comparative evaluation of efficacy of Buzzy and conventional technique in reducing pain and anxiety during Inferior Alveolar Nerve Block in children: A Split-Mouth Randomised Crossover Study

Nabiha Mahmoud1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2025年8月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
88
试验地点
1
主要终点
Percentage success of adequate anesthesia

研究概览

简要总结

This is a single-blinded, randomised, split-mouth, crossover clinical trial comparing the efficacy of the BUZZY device and the conventional technique in reducing pain and anxiety during inferior alveolar nerve block (IANB) in children aged 8–10 years. A total of 44 healthy and cooperative children(88 sites) who require bilateral IANB for mandibular teeth extraction will be selected based on specific inclusion and exclusion criteria.

Participants will be randomly allocated to receive IANB with the BUZZY device in one visit and conventional IANB without the device in a crossover manner during the second visit after a two-week washout period. The primary outcome measures will include the percentage success of adequate anesthesia evaluated through subjective and objective signs 10 minutes after the injection, pain perception using the Wong-Baker Facial Rating Scale before and after the injection, behavioral response using the FLACC scale during the injection, physiological indicators of anxiety such as pulse rate measured preoperatively, intraoperatively, and postoperatively using a fingertip pulse oximeter. The secondary outcome includes the parental and child acceptance of the BUZZY device as a counterstimulation aid during local anesthesia.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
8.00 Year(s) 至 10.00 Year(s)(—)
性别
All

入选标准

  • Healthy, co-operative children aged 8-10 years with no prior experience of an intraoral local anesthetic injection
  • Children with Frankl behavior rating in category 3 and 4.

排除标准

  • Children with known allergy to local anesthesia or its components
  • Children on long term systemic medications.

结局指标

主要结局

Percentage success of adequate anesthesia

时间窗: 10 minutes after inferior alveolar nerve block administration

次要结局

  • Pain Perception(Before and immediately after inferior alveolar nerve block administration)
  • Behavioral Response to Pain(During inferior alveolar nerve block administration)
  • Physiological response to anxiety(Before, during and after inferior alveolar nerve block)
  • Parental and child acceptance of Buzzy device(After inferior alveolar nerve block administration)

研究者

发起方
Nabiha Mahmoud
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Nabiha Mahmoud

Government Dental College and Research Institute, Bangalore

研究点 (1)

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