Evaluation of pain perceived during local anesthesia administration with different concentrations of nitrous oxide sedation in preadolescent children: A randomized crossover trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- To evaluate the pain perceived at different concentrations of nitrous oxide sedation (30% and 40%) and control (no sedation) during local anesthesia administration
研究概览
简要总结
This randomized crossover clinical trial will evaluate the effect of different concentrations of nitrous oxide sedation (30% and 40%) on pain perception during local anesthesia administration in children aged 7–12 years. The study will include children who already require dental treatment under local anesthesia through an inferior alveolar nerve block (IANB) in three separate appointments.
At each appointment, participants will receive one of three conditions: 30% nitrous oxide with oxygen, 40% nitrous oxide with oxygen, or 100% oxygen (control), in a randomized manner, with a one-week washout period between appointments.
The primary outcomes are the pain perception during injection, assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) scale, and the subjective pain immediately after injection, assessed using the Wong-Baker FACES Pain Rating Scale. Secondary outcomes include anxiety levels using the Visual Analogue Scale for Anxiety (VAS-A) and the State-Trait Anxiety Inventory for Children (STAI-CH), sedation depth using the Wisconsin Sedation Scale, physiological parameters (heart rate, blood pressure, and oxygen saturation), and recovery time using the Modified Aldrete Score.
The study aims to investigate whether these lower concentrations can provide sufficient analgesia and reduce pain perception, potentially offering a safer alternative while maintaining clinical effectiveness
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 7.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Children aged seven to twelve years requiring treatment under local anaesthesia through inferior alveolar nerve block in each visit for three visits.
- •Children with Frankel behaviour rating two.
- •Medically healthy children classified as American Society of Anesthesiologists physical status class one.
- •Children who can understand and follow instructions during the procedure.
- •Children whose parent or guardian have given consent and child assent for participation in the study.
排除标准
- •Children with severe anxiety or uncooperative behavior that may require deeper sedation or general anesthesia.
- •History of respiratory conditions such as asthma, upper airway obstruction, or sleep apnea.
- •Neurological or developmental disorders that could affect sedation response such as epilepsy, autism spectrum disorder, or attention deficit hyperactivity disorder.
- •Allergy or hypersensitivity to nitrous oxide or local anesthetic agents.
- •Children with significant nasal congestion or conditions affecting nasal breathing.
- •Recent history of sedative or anxiolytic medication use within the past twenty four hours.
- •Severe gag reflex or conditions making nitrous oxide administration difficult.
- •Children who have undergone recent dental procedures with sedation within the last four weeks.
结局指标
主要结局
To evaluate the pain perceived at different concentrations of nitrous oxide sedation (30% and 40%) and control (no sedation) during local anesthesia administration
时间窗: Subjective pain scale scored during administration of local anesthesia injection using Face, Legs, Activity, Cry, Consolability scale. | Objective pain scale scored Immediately after completion of local anesthesia injection using Wong Baker faces pain rating scale.
次要结局
- To evaluate & compare anxiety levels before & after local anesthesia administration under thirty percent & forty percent nitrous oxide sedation.(To determine the depth of sedation achieved with thirty percent & forty percent nitrous oxide.)
研究者
Charanya S
SRM Dental College, Ramapuram