COMPARISON OF THE EFFICACY OF INHALATIONAL, INTRANASAL AND ORAL SEDATIVES IN PEDIATRIC DENTAL PATIENT MANAGEMENT: A RANDOMIZED CONTROLLED TRIAL
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Level of sedation of the patient will be assessed by Modified
研究概览
简要总结
Dental fear significantly impacts pediatric dentistry, with prevalence ranging from 5.7% to 19.5%, often deterring children from regular visits and increasing oral health risks. Addressing dental anxiety is crucial to improving immediate care and preventing long-term oral health issues. Non-pharmacological methods like Tell-Show-Do, distraction, and cognitive-behavioral therapy (CBT) are effective, while pharmacological options, including sedation, are necessary for some patients.
Conscious sedation, using agents like midazolam, triclofos, and nitrous oxide, plays a key role in managing dental anxiety. Each sedation method has distinct benefits, with nitrous oxide offering rapid onset and recovery, intranasal midazolam providing effective anxiolysis, and triclofos acting as an oral sedative. However, limited randomized clinical trials compare their efficacy. This study aims to evaluate the sedative effectiveness of nitrous oxide, intranasal midazolam, and oral triclofos in pediatric dental patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 4.00 Year(s) 至 8.00 Year(s)（—）
- 性别
- All
入选标准
- •Anxious children aged between 4-8 years.
- •Children having a physical status of ASA I according to the American Society of Anaesthesiologists.
- •Children having Frankl behaviour rating scale- positive.
- •Children who require a dental procedure under local anaesthesia.
- •Fasting status of children – light meal 2 hours before undergoing dental procedure.
排除标准
- •Very uncooperative children (frankl behaviour rating – definitive negative) .
- •Children who recently used medications like erythromycin or anticonvulsants that may interfere with the pharmacokinetics of midazolam.
- •Children with known hypersensitivity to nitrous oxide -oxigen sedation, intranasal midazolam and triclofos.
- •Children with any systemic disease and special health care needs.
- •Children with any condition that predisposes them to airway obstruction or difficulties (eg COPD, allergic rhinitis, adenoid hyperplasia, nasal septum problems, enlarged turbinates or nasal polyp).
- •Children with upper or lower respiratory tract infections.
结局指标
主要结局
Level of sedation of the patient will be assessed by Modified
时间窗: immediate
Ramsay sedation sale.
时间窗: immediate
pain perception will be assessed by using wong-baker faces pain
时间窗: immediate
rating scale.
时间窗: immediate
次要结局
- overall behaniour will be asses by using Houpt Sedation Rating(Scale.)
研究者
Dr Aanchal Singh
Subharti Dental College and Hospital