Effect of External Cooling and Vibration, Counterstimulation, and Needle Type on Pain, Physiological, and Behavioral Outcomes During Inferior Alveolar Nerve Block in Pediatric Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 166
- 试验地点
- 1
研究概览
简要总结
Title of Study: Effect of External Cooling and Vibration, Counterstimulation, and Needle Type on Pain, Physiological, and Behavioral Outcomes During Inferior Alveolar Nerve Block in Pediatric Patients
Why was this study done? The inferior alveolar nerve block (IANB) is a dental injection used to numb the lower jaw and teeth in children. Many children find this injection very painful and scary. Bad experiences can make them afraid of the dentist for years. This study was designed to test different ways to make the injection less painful and stressful for children.
What did the researchers want to find out?
They planned to compare three different methods to see which one works best to reduce pain, distress, and physical signs of fear (like a fast heartbeat) during the injection:
External cooling + vibration (using a special device that cools and vibrates on the skin near the injection site)
Counterstimulation (gentle tapping or pressing with a cotton roll near the injection site)
A thinner needle (30-gauge instead of the standard 27-gauge)
Standard method (27-gauge needle with no extra distraction) - this is the control group
Who took part? The study enrolled 166 healthy children between the ages of 5 and 9 years who needed a lower jaw dental injection at Al-Mustansiriyah University Dental College.
What happened during the study?
Children were randomly placed into one of the four groups. All children received the same numbing medicine (2% lidocaine with epinephrine). Dentists gave the injection at the same speed for everyone. Researchers planned to measure:
How much pain the child felt (using the Wong-Baker Faces scale, where children point to a face showing their pain level)
How much pain the child showed (using the FLACC scale, which looks at face, legs, activity, crying, and comfort)
Heart rate and oxygen level (using a finger clip device)
How well the child cooperated (using the Frankl Behavior Rating Scale)
What outcomes are being measured? The primary outcomes are children's self-reported pain and observer-rated pain behavior. Secondary outcomes include physiological responses (heart rate and oxygen saturation) and behavioral cooperation scores. The study will compare changes in these measures across the four intervention groups.
What is the purpose of this research? The findings from this trial are expected to provide evidence to help dentists choose the most effective comfort measures to keep children calm and pain-free during lower jaw injections. The study aims to clarify whether distraction-based methods (cooling+vibration or counterstimulation) offer advantages over simply changing the needle gauge.
Were there any side effects or risks? Safety is being monitored continuously throughout the procedure via pulse oximetry (oxygen saturation) and heart rate tracking. The interventions are considered low-risk, and children who show excessive distress are withdrawn and managed according to standard care.
Who paid for this study? The study received no outside funding. The authors declared no conflicts of interest.
Where was the study done? Department of Pediatric Dentistry, Al-Mustansiriyah University, Baghdad, Iraq.
详细描述
Study Design This is a prospective, parallel-group, randomized controlled clinical trial (RCT) conducted at the Department of Pediatric Dentistry, Al-Mustansiriyah University College of Dentistry, Baghdad, Iraq. The trial is designed to compare the effectiveness of three interventions versus a standard control in reducing pain, physiological stress, and behavioral distress during inferior alveolar nerve block (IANB) in pediatric dental patients.
Participants A total of 166 medically healthy children (ASA I or II) aged 5 to 9 years, who required dental treatment under IANB, were enrolled. Inclusion criteria included a baseline Frankl Behavior Rating of 2 or 3 (cooperative or potentially cooperative). Exclusion criteria were systemic illness, neurological or developmental conditions affecting pain perception, previous traumatic dental injection experience, allergy to lidocaine or epinephrine, and significant respiratory or cardiovascular conditions.
Randomization and Allocation Children were randomly assigned to one of four groups using a sealed-envelope method to ensure allocation concealment. Group sizes: Cooling + Vibration (n=40), Counterstimulation (n=41), 30-gauge needle (n=43), and standard 27-gauge needle control (n=42).
Interventions All injections use 2% lidocaine with 1:100,000 epinephrine, administered at a controlled rate of 1 mL/min by calibrated pediatric dentists.
Cooling + Vibration group: A thermomechanical device (Buzzy®, MMJ Labs, USA) is applied externally to the injection site for 30-60 seconds before needle insertion and remains in place during anesthetic deposition. The device provides simultaneous cooling and vibration.
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
- Single (Outcomes Assessor)
盲法说明
The outcomes assessor was blinded to group assignment. Participants, care providers (dentists administering the injection), and the investigator were not masked due to the nature of the interventions (visible device, manual tapping, or needle type).
入排标准
- 年龄范围
- 5 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged 5 to 9 years. Requiring dental procedures under inferior alveolar nerve block (IANB) anesthesia.
- •Medically healthy children classified as American Society of Anesthesiologists (ASA) Class I or II.
- •Baseline Frankl Behavior Rating of 2 or 3 (indicating cooperative or potentially cooperative behavior).
- •Written informed consent obtained from parents or legal guardians. Age-appropriate assent obtained from the child. -
排除标准
- •Presence of systemic illness.
- •Neurological disorders.
- •Developmental conditions affecting pain perception.
- •Previous traumatic dental injection experiences.
- •Allergy or hypersensitivity to lidocaine with epinephrine.
- •Significant respiratory or cardiovascular conditions (to avoid confounding physiological monitoring).
- •Children who exhibit excessive distress during the procedure will be withdrawn and treated per standard care (this can be added as a withdrawal criterion if needed).
研究者
Samah Fadhil Mohamed-Ali
Lecturer, College of Dentistry, Al-Mustansiriyah University
Al-Mustansiriyah University