Sedation for Children Undergoing MRINCT06606899
A Comparison Between Oral Melatonin With Nasal Sevoflurane Versus Oral Chloral Hydrate With Nasal Sevoflurane in Sedation of Children Undergoing Brain MRI
A study testing Melatonin 3 MG, Chloral Hydrate and Sevoflurane in people with Sedation for Children Undergoing MRI, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Sedation for Children Undergoing MRI
- What is being tested?
- Melatonin 3 MG, Chloral Hydrate and Sevoflurane
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Sep 2024to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients American Society of anesthesiologists' physical status (ASA) I to II.
- Aged 2 to 5 years.
- Both sexes.
- Patients scheduled for Brain MRI.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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%.
Read more
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
Read the 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 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
- Conditions
- Sedation for Children Undergoing MRI
- Being tested
- Melatonin 3 MG, Chloral Hydrate, Sevoflurane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melatonin 3 MGDrug
Also called Melatonin
Oral syrup melatonin 3 mg
Chloral HydrateDrug
Also called Cloral hydrate
Oral chloral hydrate (50 mg/kg, maximum 2 g)
SevofluraneDrug
Inhalational Sevoflurane
| Study group | Role | What they receive |
|---|---|---|
| Group Melatonin | Experimental | Group A: will receive oral Melatonin and nasal Sevoflurane. Receives: Drug: Melatonin 3 MG; Drug: Sevoflurane |
| Group Chloral-Hydrate | Experimental | Group B: will receive oral Chloral Hydrate and nasal Sevoflurane. Receives: Drug: Chloral Hydrate; Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start20 Sep 2024
- Primary completion30 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedation for Children Undergoing MRIStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, riham fathy galal, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06606899
- Sponsor's protocol ID
- FAMSU R202/2024
- Status last verified
- Nov 2025
- First submitted
- 14 Sep 2024
- Last updated
- 20 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06606899
- Acronym / sponsor ID
- FAMSU R202/2024
- Conditions
- Sedation for Children Undergoing MRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 20 Sep 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 23 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Melatonin | Experimental | Drug: Melatonin 3 MG, Drug: SevofluraneGroup A: will receive oral Melatonin and nasal Sevoflurane. |
| Group Chloral-Hydrate | Experimental | Drug: Chloral Hydrate, Drug: SevofluraneGroup B: will receive oral Chloral Hydrate and nasal Sevoflurane. |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Patients American Society of anesthesiologists' physical status (ASA) I to II.
- Aged 2 to 5 years.
- Both sexes.
- Patients scheduled for Brain MRI.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Melatonin 3 MGAlso: MelatoninOral syrup melatonin 3 mg | Drug | Group Melatonin |
| Chloral HydrateAlso: Cloral hydrateOral chloral hydrate (50 mg/kg, maximum 2 g) | Drug | Group Chloral-Hydrate |
| SevofluraneInhalational Sevoflurane | Drug | Group Chloral-Hydrate, Group Melatonin |
Primary outcome
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).
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Melatonin 3 MG, Chloral Hydrate and Sevoflurane in people with Sedation for Children Undergoing MRI, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.