牙髓切断术治疗中新型无针局部麻醉系统（INJEX）与传统注射器针头技术的比较评估：一项随机临床试验

Comparative Evaluation of New Needleless Local Anesthetic System (INJEX) and Conventional Syringe Needle Technique during Pulpotomy Treatment: A Randomized Clinical Trial.

作者信息

Vishwanathaiah Satish, Albar Nassreen H, Alraghi Fatemah Tawfeg Abkar, Jaferi Noor Eissa Mousa, Tumayhi Ishraq Abdullah Mohammed, Panda Suman, Khormi Fatima Ali Hassan, Jaafari Atlal Hassan Hussain, Abiri Zahra Ahmed Ibrahim, Maganur Prabhadevi C

机构信息

Division of Pediatric Dentistry, Department of Preventive Dental Sciences, College of Dentistry, Jazan University, Jazan 45142, Saudi Arabia.

Restorative Dentistry Department, College of Dentistry, Jazan University, Jazan 45142, Saudi Arabia.

出版信息

Children (Basel). 2024 Apr 25;11(5):514. doi: 10.3390/children11050514.

DOI:10.3390/children11050514

PMID:38790509

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11120071/

Abstract

BACKGROUND

The dreaded sensation of pain in the dental chair has a significant impact on children's behavior. This study aimed to compare and contrast the perception of pain and patient behavior between the use of INJEX and the conventional syringe needle technique during pulpotomy among children.

METHODS

A randomized clinical trial was designed and conducted among pediatric dentistry patients aged 6-12 years old. Fifty-eight children were divided into two groups, conventional syringe needle and INJEX, using simple randomization method applying the sequentially numbered, opaque, sealed envelope method of allocation concealment. Anesthesia was administered to the groups as local infiltration by a single operator following routine behavior guidance techniques. After 3 min, pulpotomy was performed using the standard protocol. The Face, Legs, Activity, Cry, Consolability (FLACC) scale and Wong-Baker FACES Pain Rating Scale (WBS) were used to assess the intensity of pain, while the Frankl behavior rating scale (FBRS) was used to assess the children's behavior.

RESULTS

During anesthesia, most of the participants in the INJEX group (median = 3) had higher FBRS scores compared with the conventional syringe needle group (median = 2), and the difference was very highly significant (-value < 0.001). Analyzing the FLACC scores during local anesthesia administration revealed a high statistical significance (-value < 0.01) across the two groups. A very high statistically significant difference (-values < 0.001) with higher WBS scores for pain intensity was seen in the group using conventional syringe needles.

CONCLUSIONS

INJEX administration significantly reduced the intensity of pain experienced by the children and helped maintain a positive attitude among them during pulpotomy. It provided a positive and comfortable experience for both the child and the practitioner. Therefore, it can serve as an excellent alternative to conventional needle anesthesia.

摘要

背景

在牙科治疗椅上令人恐惧的疼痛感觉对儿童行为有重大影响。本研究旨在比较和对比儿童牙髓切断术中使用INJEX和传统注射器针头技术时的疼痛感知和患者行为。

方法

设计并对6至12岁的儿童牙科患者进行了一项随机临床试验。58名儿童使用简单随机化方法，采用连续编号、不透明、密封信封的分配隐藏方法，分为传统注射器针头组和INJEX组。由一名操作人员按照常规行为指导技术对两组进行局部浸润麻醉。3分钟后，按照标准方案进行牙髓切断术。使用面部、腿部、活动、哭闹、安慰（FLACC）量表和 Wong-Baker面部表情疼痛评分量表（WBS）评估疼痛强度，同时使用弗兰克尔行为评分量表（FBRS）评估儿童行为。

结果

在麻醉过程中，与传统注射器针头组（中位数 = 2）相比，INJEX组的大多数参与者（中位数 = 3）的FBRS评分更高，差异非常显著（P值 < 0.001）。分析局部麻醉给药期间的FLACC评分发现，两组之间具有高度统计学意义（P值 < 0.01）。在使用传统注射器针头的组中，疼痛强度的WBS评分存在非常高的统计学显著差异（P值 < 0.001）。