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临床试验/CTRI/2025/08/092844
CTRI/2025/08/092844尚未招募不适用

Premedication in paediatric patients undergoing MRI: comparative study of intramuscular ketamine 3mg/kg with dexmedetomidine 1.5mcg/kg versus ketamine 3mg/kg with midazolam 0.05mg/kg

Sri Sathya Sai Institute of Higher Medical Sciences1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年8月20日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
试验地点
1
主要终点
1.To assess ease of parental separation

研究概览

简要总结

A  total of sixty patients aged between one to ten years undergoing elective MRI will be enrolled in the study and will be randomly divided in to two groups DK-dexmedetomidine ketamine and group MK-midazolam ketamine.DK groups will receive intramuscular injection of ketamine 3mg/kg with dexmedetomidine 1.5mcg/kg and group MK will receive intramuscular injection of ketamine 3 mg/kg with midazolam 0.05mg/kg. Injection glycopyrrolate at dose of 5mcg/kg will be given to both groups. Baseline vitals will be recorded. Following this, intramuscular injection at anterolateral aspect of thigh will be given. After ten minutes of injection, attempt will be made to separate the child from the parent and ease of parent separation will be assessed according to scoring scale. Once child is separated, an attempt for securing an intravenous cannula will be done and the ease of securing the cannula will also be given scores according to the scale. After this, child will be taken into the mri suite. pulse rate, oxygen saturation, respiratory rate and blood pressure will be documented every five minutes till the first thirty minutes of procedure followed by documentation every fifteen mins till two hours. If child awakens during the procedure intravenous propofol at a dose of 0.5mg/kg will be given and the total dose will be recorded. Once the procedure is completed child will be transferred to the recovery room and will be observed till the child meets the discharge criteria. Time taken to fulfill the criteria will also be recorded.

Parent separation anxiety scale

  • Patient unafraid, cooperative, asleep=1
  • Slight fear or crying, cooperative with reassurance=2
  • Moderate fear, crying, not quiet with reassurance=3
  • Crying, need for restraint=4

Ease of IV cannulation

  • No reaction=1
  • Minor resistance=2
  • Fights without success=3
  • Fights with success=4

Discharge criteria

  • Cardiovascular function and airway patency are satisfactory and stable
  • The patient is easily arousable, and protective reflexes are intact
  • The patient can talk/phonate (if age appropriate)
  • The patient can sit up unaided (if age appropriate)
  • For a very young or handicapped child incapable of the usually expected responses, the pre sedation level of responsiveness or a level as close as possible to the normal level for the child should be achieved
  • The state of hydration is adequate

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

  • All patients between the age group of 1 to 10 years belonging to ASA I and II scheduled for elective MRI under sedation will be included in the study.

排除标准

  • Patients with active upper respiratory tract infections.
  • Patients with history of psychiatric illness.
  • Patients with morbid obesity and syndromic children.
  • Patients with raised intracranial tension.
  • Patients with history of known allergy to any of the study drugs, will be excluded from the study.

结局指标

主要结局

1.To assess ease of parental separation

时间窗: Attempt to seperate from parent-Ten minutes after the intramuscular injection. | 2.attempt for iv cannulation -one minute after seperating from parent | 3.To assess the requirement of additional supplementation of IV propofol:propofol will be given if the child awakens during the mri procedure

2.To assess acceptance of iv cannulation

时间窗: Attempt to seperate from parent-Ten minutes after the intramuscular injection. | 2.attempt for iv cannulation -one minute after seperating from parent | 3.To assess the requirement of additional supplementation of IV propofol:propofol will be given if the child awakens during the mri procedure

3.To assess the requirement of additional supplementation of IV propofol during the procedure.

时间窗: Attempt to seperate from parent-Ten minutes after the intramuscular injection. | 2.attempt for iv cannulation -one minute after seperating from parent | 3.To assess the requirement of additional supplementation of IV propofol:propofol will be given if the child awakens during the mri procedure

次要结局

  • 1.To compare heart rate, blood pressure, respiratory rate & oxygen saturation in both groups during procedure.(2.To compare the readiness of discharge from recovery room.)

研究者

申办方类型
Other [Trust Hospital]
责任方
Principal Investigator
主要研究者

Anuja Gopi

Sri Satya Sai Institute of Higher Medical Sciences

研究点 (1)

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