A Comparative Study Between Efficacy of Combined Oral Melatonin With Nasal Sevoflurane Versus Combined Oral Chloral Hydrate With Nasal Sevoflurane in Sedation of Pre-school Children Undergoing Brain Magnetic Resonance Imaging
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Ramsey sedation scale recorded before starting the MRI exam.Ramsey sedation scale is a 6-point scoring system used to assess a patient's level of arousal and sedation. The scores range from 1 (anxious and agitated) to 6 (unresponsive to pain).
研究概览
简要总结
The patients will be randomized into 2 equal groups by a computer-generated random numbers table, named group A, B.
Group A: will receive oral Melatonin and nasal Sevoflurane. Group B: will receive oral Chloral Hydrate and nasal Sevoflurane. In group A, Approximately 45 to 60 min prior to the intended scan time, the children will be given syrup melatonin 3 mg. Before starting the MRI scan, nasal sevoflurane will be started after positioning of the child at a concentration of 1%.
In Group B, the child will receive oral chloral hydrate (50 mg/kg, maximum 2 g) in syrup form was given to patients requiring sedation. Before starting the MRI scan, nasal sevoflurane will be started after positioning of the child at a concentration of 1% and will be increased gradually as needed to achieve adequate level of sedation.
The child will wait on a general hospital bed in a darkened room with its parents/carers at the rest room. When the radiology technicians decide; the child could be scanned, the child will then be transported in the arms of the parents/carers. Prior to entering the scanning room, the children and parents/carers will be checked for metal to ensure safe entrance. The child will then be lifted from the bed onto the MRI scanning table. Children will be scanned with headphones. If children did not fall asleep or if they woke up.
The MRI scan will be started. After the scanning procedure, the child and its parents/carers will be allowed to go home if the child feels well. All scans will be done on a 1.5 Tesla MR system, using a regular head coil. The MRI studies will be performed during daytime, the protocol duration will range from approximately 10 to 30 min, including positioning of the patient on the scan table. In case children move, radiology technicians could pause the study till the patients is adequately sedated and stops movement. An MRI scan will be considered to have failed when; the entire MRI scan was not assessable because of movement or in the presence of moved scans
详细描述
The patients will be randomized into 2 equal groups by a computer-generated random numbers table, named group A, B.
Group A: will receive oral Melatonin and nasal Sevoflurane. Group B: will receive oral Chloral Hydrate and nasal Sevoflurane. In group A, Approximately 45 to 60 min prior to the intended scan time, the children will be given syrup melatonin 3 mg. Before starting the MRI scan, nasal sevoflurane will be started after positioning of the child at a concentration of 1%.
In Group B, the child will receive oral chloral hydrate (50 mg/kg, maximum 2 g) in syrup form was given to patients requiring sedation. Before starting the MRI scan, nasal sevoflurane will be started after positioning of the child at a concentration of 1% and will be increased gradually as needed to achieve adequate level of sedation.
The child will wait on a general hospital bed in a darkened room with its parents/carers at the rest room. When the radiology technicians decide; the child could be scanned, the child will then be transported in the arms of the parents/carers. Prior to entering the scanning room, the children and parents/carers will be checked for metal to ensure safe entrance. The child will then be lifted from the bed onto the MRI scanning table. Children will be scanned with headphones. If children did not fall asleep or if they woke up.
The MRI scan will be started. After the scanning procedure, the child and its parents/carers will be allowed to go home if the child feels well. All scans will be done on a 1.5 Tesla MR system, using a regular head coil. The MRI studies will be performed during daytime, the protocol duration will range from approximately 10 to 30 min, including positioning of the patient on the scan table. In case children move, radiology technicians could pause the study till the patients is adequately sedated and stops movement. An MRI scan will be considered to have failed when; the entire MRI scan was not assessable because of movement or in the presence of moved scans
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 2 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients American Society of anesthesiologists' physical status (ASA) I to II.
- •Aged 2 to 5 years.
- •Both sexes.
- •Patients scheduled for Brain MRI.
排除标准
- •Parent refusal.
- •ASA physical status III or more.
- •Patients with known allergy to any of the study drugs.
- •Children with COSA.
- •Patients with history of cardiovascular disease.
- •Patients older than 5 years.
- •Patients with neuromuscular disease.
- •Patients younger than 2 years.
- •Patients suffering from respiratory tract infection.
- •Patients with family history of malignant hyperthermia.
- •Patients with any Musculoskeletal disorder.
研究组 & 干预措施
Group Melatonin
Group A: will receive oral Melatonin and nasal Sevoflurane.
干预措施: Melatonin 3 MG (Drug)
Group Melatonin
Group A: will receive oral Melatonin and nasal Sevoflurane.
干预措施: Sevoflurane (Drug)
Group Chloral-Hydrate
Group B: will receive oral Chloral Hydrate and nasal Sevoflurane.
干预措施: Chloral Hydrate (Drug)
Group Chloral-Hydrate
Group B: will receive oral Chloral Hydrate and nasal Sevoflurane.
干预措施: Sevoflurane (Drug)
结局指标
主要结局
Ramsey sedation scale recorded before starting the MRI exam.Ramsey sedation scale is a 6-point scoring system used to assess a patient's level of arousal and sedation. The scores range from 1 (anxious and agitated) to 6 (unresponsive to pain).
时间窗: 3 months
Ramsey sedation scale recorded before starting the MRI exam. After completion of data collection, we also analyzed 'Ramsey seadtion scale' because it was clinically relevant but not prospectively specified. This analysis is therefore post-hoc.
次要结局
未报告次要终点
研究者
riham fathy galal
Lecturer
Ain Shams University