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临床试验/CTRI/2024/05/066745
CTRI/2024/05/066745尚未招募4 期

To study and compare efficacy of anaesthetic premedication in the form of intranasal dexmedetomidine and ketamine v/s intranasal midazolam v/s intranasal ketamine and midazolam in the paediatric age group

Swami Rama Himalayan University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年5月14日最近更新:

试验速览

阶段
4 期
状态
尚未招募
入组人数
120
试验地点
1
主要终点
parental separation anxiety based on a 4 point scoring system

研究概览

简要总结

AIMS AND OBJECTIVES

1.    To study and compare efficacy of anaesthetic premedication in the form of intranasal dexmedetomidine and ketamine v/s intranasal midazolam v/s intranasal ketamine v/s intranasal midazolam in the paediatric age group

2.To compare the different groups on the basis of proportion of children achieving acceptable parental separation as the primary outcome and sedation onset time, degree of sedation, mask acceptance, emergence delirium, post operative agitation, post operative nausea and vomiting, Perioperative opoid use and hemodynamics as the secondary outcome

BRIEF SUMMARY :

Hospitalisation and surgery can provoke significant stress and anxiety in children. The induction of anaesthesia may be the most distressing procedure a child experiences during the entire perioperative period .It has been shown that children who are extremely anxious and fearful during anaesthetic induction are likely to develop adverse clinical outcomes such as emergence delirium, increased analgesic requirements and negative postoperative behavioural changes such as sleep disturbance, separation anxiety, eating problems, new-onset enuresis and aggression towards authority which can sometimes persist upto 4-6 months after the procedure and is also associated with poor clinical recovery. A stressful perioperative experience can also result in poor compliance with future medical therapy, including anaesthesia. Minimising distress is thus not only an ethical imperative but also important for preventing long-term behavioural problems .Premedication refers to the administration of medication before induction of anaesthesia. In the pharmacological component, the available routes of premedication are rectal, intramuscular, oral, intranasal, topical (eg-before cannulation), intravenous . The benefits of intranasal route include non invasiveness, easy administration, more compliance, requires minimal training, shorter time of onset (rapid absorption), higher bioavailability (no first pass metabolism) so drug delivery is directly to the target organ, decreased systemic adverse effects, better absorption due to highly vascularised subepithelial tissue, no gastric adverse effects, safe and convenient.Owing to the challenges with individual drugs, the need arises to consider ideal drug combinations that can provide us the desired effect with minimal adverse events . A combination of ketamine and midazolam produces 90% successful anxiolysis as compared to <75% when either drug is given alone. The combination also works in achieving a greater degree of sedation and better analgesia and amnesia

We are taking a combination of dexmedetomidine with ketamine as it has a faster onset of action, prolonged sedation and also the combination of dexmedetomidine with ketamine reduces its cardiovascular effects and slowers the elimination, as dexmedetomidine is a strong inhibitor of the N-demethylation of ketamine to norketamine. Dexmedetomidine does not appear to be the ideal agent for painful procedures but when used together with ketamine, dexmedetomidine may limit the tachycardia, hypertension, salivation, and emergence phenomena from ketamine, whereas ketamine may prevent the bradycardia and hypotension from dexmedetomidine. A combination of ketamine and dexmedetomidine has low incidence of adverse effects, good analgesic, predictable recovery and no cardiorespiratory depression.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Double

入排标准

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

入选标准

  • Children in the age group of 2-10 years ASA grade 1 or 2 Either sex Undergoing elective surgery procedures requiring GA with either Endotracheal Tube/Laryngeal mask airway for those patients in which consent has been given.

排除标准

  • children less than 2 and more than 10 years ASA grade more than 2 emergency surgeries known allergies to the above mentioned drugs developmental delays/mental retardation history of sedative/analgesic intake history of congential heat disease/arrythmias case of URTI significant nasal discharge/obstruction severe trauma of nose.

结局指标

主要结局

parental separation anxiety based on a 4 point scoring system

时间窗: time interval taken to achieve a parental separation score of more than or equal to 2 as a desirable parameter

次要结局

  • mask acceptance(intraop opiod use)

研究者

申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Tanmaya Sachdeva

Swami Rama Himalayan University

研究点 (1)

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