Comparing the Effectiveness of Several Local Anaesthesic Systems and Thier Effect on Pain Anxiety Behaviour and Vital Signs in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Pain level during dental anesthesia and treatment (behavioral assessment)
研究概览
简要总结
compare the effectiveness of several local anesthetic delivery systems in managing pain, anxiety, behavior, and vital signs among pediatric dental patients. A total of 112 children aged 6 to 10 years were included and randomly assigned to receive local anesthesia via one of the following methods: conventional syringe, computer-controlled local anesthetic delivery system (Star Pen), needle-free injector (Comfort-In), or a vibrotactile device (Vibraject). Pain was assessed using the FLACC and Wong-Baker FACES scales, anxiety with the Venham Picture Test, and behavior with the Houpt scale. Vital signs including pulse and oxygen saturation were recorded during treatment. Additionally, satisfaction levels of both the patients and their parents were evaluated using structured questionnaires and Likert scales. The study seeks to determine which technique provides the most comfortable and effective experience for children undergoing dental procedures.
详细描述
Local anesthesia is essential for pain control during pediatric dental procedures, yet its administration can cause significant anxiety and distress in children. Recent innovations aim to improve the delivery of anesthesia to make it less painful and more acceptable. This randomized clinical trial investigated and compared four local anesthetic systems: traditional syringe, computer-controlled local anesthetic delivery (CCLAD) using the Star Pen, needle-free injection using Comfort-In, and vibrotactile stimulation with Vibraject.
A total of 112 healthy children aged 6 to 10 years participated in the study. The children were randomly assigned to one of the four anesthesia groups. Pain perception was measured using both the FLACC scale and the Wong-Baker FACES Pain Rating Scale. Anxiety was evaluated using the Venham Picture Test before and during the procedure. Child behavior was rated using the Houpt Behavioral Scale. Vital signs including pulse rate and oxygen saturation were monitored at baseline and during treatment. In addition, satisfaction levels were assessed for both the pediatric patients and their accompanying parents, using child-friendly satisfaction questionnaires and parent-rated Likert scales.
This study aims to identify the anesthesia delivery method that best minimizes pain and anxiety, optimizes behavior, maintains physiological stability, and maximizes satisfaction, thereby enhancing the quality of care in pediatric dentistry.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 6-10 years.
- •Physically healthy with no neurological disorders or systemic diseases.
- •Children classified as positive" or "negative-positive" according to the modified Frankl Behavioral Rating Scale.
- •Not taking any sedatives or analgesics drugs
排除标准
- •Uncooperative children who exhibit clear behavioral problems.
- •Children with systemic diseases or disorders that may interfere with local anesthesia.
- •Use of any medications that may affect vital signs or pain response.
- •Presence of infection at the injection site.
研究组 & 干预措施
Conventional Syringe Group
28 Child received local anesthesia using a traditional dental syringe with standard technique.
干预措施: Conventional syringe injection (Device)
CCLAD - Star Pen Group
28 Child received Local anesthesia using the Star Pen computer-controlled delivery system
干预措施: Star Pen (Device)
Comfort-In - Needle-Free Group
28 Child received local anesthesia using the Comfort-In needle-free jet injector system.
干预措施: Comfort-In (Device)
Vibraject - Vibrotactile Device Group
28 Child received Local anesthesia using a conventional syringe while applying the Vibraject vibrotactile stimulation device.
干预措施: Vibraject (Device)
结局指标
主要结局
Pain level during dental anesthesia and treatment (behavioral assessment)
时间窗: From the start of local anesthetic injection until completion of pulpotomy, assessed up to 30 minutes.
Procedural pain was assessed using the FLACC scale, which evaluates five behavioral categories (Face, Legs, Activity, Cry, Consolability), each scored from 0 to 2, for a total score range of 0-10. Higher scores indicate greater pain.Scores were assigned by trained observers during the procedure.
Pain level during dental anesthesia and treatment (self-reported)
时间窗: From the start of local anesthetic injection until completion of pulpotomy, assessed up to 30 minutes.
Procedural pain was assessed using the Wong-Baker FACES Pain Rating Scale to measure children's self-reported pain, It's a self-reported scale with six cartoon faces representing increasing levels of pain, scored from 0 (no pain) to 10 (worst pain). Children were asked to point to the face that best described their pain. Higher scores on either scale indicated greater pain intensity.
Anxiety level during dental anesthesia and treatment
时间窗: From the start of local anesthetic injection until completion of pulpotomy, assessed up to 30 minutes.
Anxiety was measured using the Venham Picture Test (VPT),The test consists of eight pairs of cartoon images, each pair containing one figure showing a relaxed expression and one showing an anxious expression. Children were asked to choose the picture that best reflected how they felt. Scores ranged from 0 to 8, with higher scores indicating greater anxiety.
次要结局
- Patient satisfaction with anesthesia technique(Immediately after the procedure)
- Parental satisfaction with anesthesia technique(Immediately after the procedure)
- Child behavior during dental procedures(From the start of local anesthetic injection until completion of pulpotomy, assessed up to 30 minutes.)
- Heart rate(From baseline measurement taken 5 minutes before local anesthetic injection, through the injection, and until completion of pulpotomy, assessed up to 35 minutes.)
- Patient satisfaction with anesthesia technique(Immediately after the procedure)
- Parental satisfaction with anesthesia technique(Immediately after the procedure)
- Oxygen saturation during dental procedures(From baseline measurement taken 5 minutes before local anesthetic injection, through the injection, and until completion of pulpotomy, assessed up to 35 minutes.)