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临床试验/CTRI/2026/02/102691
CTRI/2026/02/102691尚未招募4 期

Evaluation of the effectiveness of oral Melatonin as a premedication to intranasal Dexmedetomidine for sedation in paediatric patients undergoing magnetic resonance imaging

Government Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2026年2月11日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
80
试验地点
1

研究概览

简要总结

Magnetic Resonance Imaging (MRI) in children requires complete immobility in a noisy and confined environment, which is often not achievable without sedation. Intranasal dexmedetomidine is an effective, non-invasive sedative agent that provides deep sedation while preserving spontaneous respiration, yet higher doses may prolong recovery or cause haemodynamic effects. However, intravenous rescue sedation may be required in some children. Oral melatonin, a natural hormone regulating circadian rhythm, has also been used safely in paediatric practice as a premedication and in combination with other sedatives, where it has caused anxiolysis, smoother recovery, and reduced emergence agitation. Previous attempts to combine dexmedetomidine with agents like midazolam, ketamine or propofol have been constrained by adverse effects, but combining it with melatonin offers a more promising and complementary approach. However, the role of melatonin as a premedication with intranasal dexmedetomidine in paediatric MRI has been evaluated sparingly. Whether melatonin enhances sedation success, reduces the requirement of rescue intravenous sedation, shortens onset time, and improves recovery when combined with intranasal dexmedetomidine remains unknown. This knowledge gap forms the basis of the present study. We hypothesize that oral melatonin given as a premedication to intranasal dexmedetomidine will increase the rate of successful MRI sedation (completion without IV rescue and with UMSS of more than or equal to 3), shorten the onset time to adequate sedation, and improve recovery characteristics, compared with intranasal dexmedetomidine alone.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

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

入选标准

  • 1.Children aged 1 to 10 years of either sex 2.American Society of Anaesthesiologists, physical status 1 to 3 3.Scheduled for elective, non contrast brain MRI.

排除标准

  • 1.Refusal of consent by parents/guardians Recent 2.upper respiratory tract infection (less than 2 weeks) 3.Inadequate fasting status (solids less than 6h, clear fluids less than 2h) 4.Nasal deformity/obstruction (e.g. Choanal atresia) 5.Anticipated difficult airway 6.Significant systemic disease or contraindication to study drugs.

研究者

发起方
Government Medical College and Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Ishita Gupta

Government Medical College and Hospital, Chandigarh

研究点 (1)

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