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临床试验/CTRI/2024/01/061815
CTRI/2024/01/061815已完成2/3 期

Comparative Evaluation of Intranasal Dexmedetomidine-Ketamine, Ketamine-Midazolam and Nitrous oxide-Oxygen inhalation for conscious sedation of 5-10 year old Anxious Children Undergoing Dental Treatment: A Randomised Clinical Trial

Saveetha Dental College and Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年1月29日最近更新:

试验速览

阶段
2/3 期
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Level of sedation

研究概览

简要总结

Any medical or dental procedure aims to complete treatment with least or no discomfort. In pediatric patiets , anxiety and fear are the most common reasons for difficulty in behaviour management.There are two different kinds of behaviour management techniques - non pharmacological and pharmacological.When non pharmacological behvaiour management techniques fail , pharmacological sedatives are used as alternatives.There are various drugs and routes of administration employed.In this study the intranasal route is opted as it is non-invasive ,less traumatic to pediatric patients and has faster onset as it bypassess the first pass metabolism.Previous literature showed evidence of individual drugs used for intranasal sedation . In this study combination of such drugs(dexmedetomidine-ketamine and ketamine-midazolam) are used to check if there are any added advantages such as faster onset of sedation and recovery.And also to check if one drug overcomes the disadvantage of another.For example, midazolam casues bradycardia ad ketamine causes tachycardia,the combination might cause a nullification of the individual effects.

研究设计

研究类型
Interventional
分配方式
Other
盲法
None

入排标准

年龄范围
5.00 Year(s) 至 10.00 Year(s)(—)
性别
All

入选标准

  • ASA 1 Frankl behaviour rating 1 Pulpotomy Pulpectomy.

排除标准

  • Not cleared by anaesthetist for sedation Any known allergy,hypersensitive reaction Recent administration of erythromycin,anticonvulsant.
  • as they may interfere with pharmacokinetics of midazolam,ketamine.

结局指标

主要结局

Level of sedation

时间窗: Before start of treatment , After administration of local anaesthetic , during biomechanical preparation , after completion of treatment.

次要结局

  • Behaviour rating(Before start of treatment , After administration of local anaesthetic , during biomechanical preparation , after completion of treatment.)
  • total sedation time(from onset of sedation to recovery (in minutes))
  • Pulse rate (in bpm)(At start ,10 minutes, 20 minutes, 30 minutes , 40 minutes , 50 minutes, 60 minutes, 70 minutes , 80 minutes , at time of discharge)
  • Oxygen Saturation(At start ,10 minutes, 20 minutes, 30 minutes , 40 minutes , 50 minutes, 60 minutes, 70 minutes , 80 minutes , at time of discharge)

研究者

发起方
Saveetha Dental College and Hospital
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Nandini Devi M

Saveetha Dental College and Hospitals

研究点 (1)

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