Comparative evaluation of the efficacy of intranasal atomised dexmedetomidine, atomised midazolam and nitrous oxide-oxygen inhalation for conscious sedation of 6-8 year old anxious children undergoing dental treatment: A Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Intra- and Post-op pain
研究概览
简要总结
Dental treatment has always been considered as an anxiety-provoking experience for many children. For these children, many different forms and different drugs have been used by operators for their sedation and dental treatment. These commonly include midazolam (i.v, oral or intranasally), dexmedetomidine or nitrous oxide-oxygen. Midazolam is considered as the “ potentially idel sedative agent†with a wide toxic/therapeutic ratio and safety margin. Dexmedetomidine is one of the safest drugs causing least respiratory depression. Nitrous oxide-oxygen is the “standard technique’†used in dental operatories for concious sedation. All 3 agents have their own advantages and comparing them will help us to conclude which is the most effective and safest for paediatric dental treatment. Moreover, intranasal route allows patient to maintain nil per oral and therefore chances of aspiration are very less.
**Aim:**To compare the efficacy of intranasal atomized intranasal dexmedetomidine, atomized midazolam and nitrous oxide-oxygen inhalation for conscious sedation of 6-8 year old anxious children undergoing dental treatment
Objectives :
To evaluate & compare:
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the sedative efficacy of atomized intranasal dexmedetomidine, atomized midazolam and nitrous oxide-oxygen for concious sedation in pediatric dental treatment.
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the effect on behaviour after the use of atomized intranasal dexmedetomidine, atomized intranasal midazolam and nitrous oxide-oxygen for concious sedation in pediatric dental treatment.
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the recovery time after administration of atomized intranasal dexmedetomidine, atomized intranasal midazolam and nitrous oxide- oxygen for concious sedation in pediatric dental treatment.
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the intra- & post-op pain during treatment after administration of atomized intranasal dexmedetomidine, atomized midazolam and nitrous oxide-oxygen for concious sedation in pediatric dental treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 6.00 Year(s) 至 8.00 Year(s)（—）
- 性别
- All
入选标准
- •1.ASA I Category 2.Behavior category: Frankl Scale 2 negative 3.Requiring pulpectomy in at least three posterior teeth in the lower arch 4.No cognitive impairment.
排除标准
- •1.Patients who recently used medications like erythromycin or anticonvulsants that may interfere with the pharmacokinetics of midazolam.
- •2.Children with any condition that predisposes them to airway obstruction or difficulties (eg adenoid hyperplasia, nasal septum problems, enlarged turbinates or nasal polyp).
- •3.Frankl scale #1 (definitely negative) 4.Children with upper or lower respiratory tract infections
- •Children with special health care needs.
结局指标
主要结局
Intra- and Post-op pain
时间窗: Assessment of sedation and behaviour | Intra- and Post-op pain
Assessment of sedation and behaviour
时间窗: Assessment of sedation and behaviour | Intra- and Post-op pain
次要结局
- Physiologic signs (Blood pressure, SPO2, Pulse rate)(Recovery time)