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临床试验/CTRI/2025/07/091863
CTRI/2025/07/091863尚未招募4 期

A Comparative Evaluation Of Intranasal Ketamine And Intranasal Midazolam For Premedication In Children

Shri Guru Ram Rai Institute Of Medical And Health Sciences1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2025年8月9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
72
试验地点
1
主要终点
Parent Separation Score

研究概览

简要总结

A Comparative Evaluation Of Intranasal Ketamine And Intranasal Midazolam For Premedication In Children Aged Between Three To Eight Years Coming To Shri Guru Ram Rai Institute Of Medical And Health Sciences For Elective Paediatric Surgeries Will Be Conducted And Parent Separation Score Will Be Seen As Primary Outcome. Mask Acceptance Score Generalised Anxiety Score And Ramsay Sedation Score Will Be Evaluated As Secondary Outcome In Seventy Two Patients After Taking Written Informed Consent

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
3.00 Year(s) 至 8.00 Year(s)(—)
性别
All

入选标准

  • Weight between 10 To 20 Kilogram And ASA Class One.

排除标准

  • Emergency Surgeries And Patients Allergic To Study Drugs.

结局指标

主要结局

Parent Separation Score

时间窗: Baseline (10 Minutes Before Shifting To Operation Theatre)

次要结局

  • Mask Acceptance Score(Immediate Preoperatively)
  • Generalised Anxiety Score(Immediate Preoperatively)
  • Vital Parameters(Perioperative Period Till 24 Hours)
  • Drug Related Complications(Till 24 Hours Postoperatively)
  • Ramsay Sedation Score(Immediate Preoperatively Before Shifting To Operation Theatre to 24 hours Postoperatively)

研究者

发起方
Shri Guru Ram Rai Institute Of Medical And Health Sciences
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Vishal Pratap Singh

Shri Guru Ram Rai Institute Of Medical And Health Sciences

研究点 (1)

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