Sedation Spectrum: Navigating Pediatric Comfort With Oral Midazolam, Intranasal Midasolam And Nitrous Oxide In Pediatric Dentistry.
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
研究概览
简要总结
A total n= 90 anxious pediatric patients aged 4-10 years with Frankl behavior rating 2 & ASA 1 whose treatment require pulpotomy/pulpectomy would be randomized by chit picking method like 90 chits 30 of each group would be made and patient would be asked to pick one to receive oral midazolam (Group 1), intranasal midazolam (Group 2) & inhalational nitrous oxide – oxygen combination (Group 3).Total 90 patients are divided equally into 3 groups. Before enrollment of the patients into the study, the risks and benefits of the study would be explained to the parents/guardians and written consent would be obtained from the parents. The patient would be instructed to follow the pre procedural guidelines.Group 1 – would receive 0.5mg/kg oral midazolam (MIDAZOLAM HYDROCHLORIDE IV SOLUTION) combine with sweet orange flavored glucose syrup to avoid patients’ anxiety about having the medicine before treatment.Group 2 – would receive 0.5mg/kg intranasal midazolam spray (INSED ATOMIZER) using mucosal atomizer attached to the medicine itself.Group 3 - would receive nitrous oxide oxygen inhalation at concentration 40-60%.
**Observational Parameters:**Behavior of patient using Houpt’s sedation scale, Ramsay Sedation Scale, Acceptance of drug, Time of Onset of sedation and Parental satisfaction.
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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 and Outcome Assessor Blinded
入排标准
- 年龄范围
- 4.00 Year(s) 至 10.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Children aged 4 to 10 years 2 ASA 1 score & Frankl behavior rating 2 3 Need to undergo dental procedure like pulpectomy under local anesthesia 4 In whom non pharmacological behavior technique have not been successful.
排除标准
- •1 Who would not be cleared by anesthetist for sedation 2 Any known allergy or hypersensitivity reaction to the drugs being used 3 Who would be given any analgesics 6 hours before the procedure 4 Who would be recently administered drugs like erythromycin, clarithromycin, fluconazole or anticonvulsants which interfere with pharmacokinetics of midazolam 5 Any known case of any type of systemic medical illness like breathing difficulties, cognitive impairment, etc.
研究者
Dr Rajal Udaybhai Dave
Government Dental College And Hospital, Ahmedabad