Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06606899
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-14
Brief Title:
A Comparison Between Oral Melatonin With Nasal Sevoflurane Versus Oral Chloral Hydrate With Nasal Sevoflurane in Sedation of Children Undergoing Brain MRI
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 mgkg 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 parentscarers 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 parentscarers Prior to entering the scanning room the children and parentscarers 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 parentscarers will be allowed to go home if the child feels well All scans will be done on a 15 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
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 mgkg 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 parentscarers 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 parentscarers Prior to entering the scanning room the children and parentscarers 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 parentscarers will be allowed to go home if the child feels well All scans will be done on a 15 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
Detailed Description:
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 mgkg 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 parentscarers 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 parentscarers Prior to entering the scanning room the children and parentscarers 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 parentscarers will be allowed to go home if the child feels well All scans will be done on a 15 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
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 mgkg 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 parentscarers 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 parentscarers Prior to entering the scanning room the children and parentscarers 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 parentscarers will be allowed to go home if the child feels well All scans will be done on a 15 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None