Evaluation of Efficacy, Acceptance and Reactivity of Intranasal Midazolam with Lignocaine for Conscious Sedation in 5-8 year Old Children for Dental Procedures in Primary Teeth : A Clinical Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The results of the present study will provide the dental professionals, the best evidence for co-relation of mode of intranasal sedation using INM with MAD
研究概览
简要总结
Very young children often lack cooperative ability and need to be sedated for extensive dental treatment. Hence a needless and painless route of drug administration may be useful to obtain short-term sedation for diagnostic and painful procedures in uncooperative children which can be achieved by INM which is successfully used in a variety of Pediatric clinical situations.By INM with Lignocaine we can enhance the patient’s physical comfort and safety and to control anxiety and behavior, as well as to allow for the completion of the procedure this will lead better patient compliance
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 5.00 Year(s) 至 8.00 Year(s)（—）
- 性别
- All
入选标准
- •Frankle behaviour rating scale Class III or IV children will be included Patient without any systemic illness Preoperative heart rate of 55 to 100 beats per minute and Respiratory rate of 14 to 16 beats per minute Maximum blood pressure reading of 140 100 mmHg Patients who require at least one restoration or extraction of grade II or III mobile primary tooth Parents giving consent for the study.
排除标准
- •A history of any systemic disease where benzodiazepam is contraindicated An upper respiratory tract infection with nasal discharge or respiratory distress A history of allergy or intolerance to benzodiazepines.
结局指标
主要结局
The results of the present study will provide the dental professionals, the best evidence for co-relation of mode of intranasal sedation using INM with MAD
时间窗: outcome will be assessed/estimated at the time of adminstration of drug and post op with one day follow up
次要结局
- evaluate and acceptance of INM(outcome will be assessed/estimated at the time of adminstration of drug and post op with one day follow up)