| CTRI Number |
CTRI/2026/02/102691 [Registered on: 02/02/2026] Trial Registered Prospectively |
| Last Modified On: |
31/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Impact of oral Melatonin on sedation and recovery with intranasal Dexmedetomidine in children undergoing MRI. |
|
Scientific Title of Study
|
Evaluation of the
effectiveness of oral Melatonin as a premedication to intranasal Dexmedetomidine for
sedation in paediatric patients undergoing magnetic resonance imaging |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ishita Gupta |
| Designation |
Juinor resident |
| Affiliation |
Government Medical College and Hospital, Chandigarh |
| Address |
Department of Anaesthesia and Intensive care, Block D, Level 5, GMCH, Sector 32-B, Chandigarh
Chandigarh CHANDIGARH 160030 India |
| Phone |
9501411147 |
| Fax |
|
| Email |
ishitagupta1999@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Richa Saroa |
| Designation |
Professor |
| Affiliation |
Government Medical College and Hospital, Chandigarh |
| Address |
Department of Anaesthesia and Intensive care, Block D, Level 5, GMCH, Sector 32-B, Chandigarh
Chandigarh CHANDIGARH 160030 India |
| Phone |
9646121513 |
| Fax |
|
| Email |
richajayant@rediffmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sanjeev Palta |
| Designation |
Professor |
| Affiliation |
Government Medical College and Hospital, Chandigarh |
| Address |
Department of Anaesthesia and Intensive care, Block D, Level 5, GMCH, Sector 32-B, Chandigarh
Chandigarh CHANDIGARH 160030 India |
| Phone |
9646121523 |
| Fax |
|
| Email |
sanjeev_palta@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College and Hospital, sector 32-B, Chandigarh |
|
|
Primary Sponsor
|
| Name |
Government Medical College and Hospital |
| Address |
Department of Anaesthesia and Intensive care, Block D, Level 5, GMCH, Sector 32-B, Chandigarh |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ishita Gupta |
Government Medical College and Hospital, sector 32-B Chandigarh |
Department of Anaesthesia and Intensive care, Block D, Level 5, GMCH, Sector 32-B, Chandigarh
Chandigarh
CHANDIGARH
160030
India Chandigarh CHANDIGARH |
9501411147
ishitagupta1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE(GMCH, Chandigarh) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G00-G99||Diseases of the nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
oral Melatonin |
Oral melatonin syrup (0.25 mg per kg up to a maximum of 3
mg for children more than or equal to 15 kg, or up to a maximum of 6 mg for children more than or equal to 15 kg)
administered 40 minutes before MRI, followed by intranasal dexmedetomidine (2.5
µg per kg) administered 30 minutes before MRI. |
| Comparator Agent |
placebo |
Placebo syrup (honey solution, equal volume) administered 40
minutes before MRI, followed by intranasal dexmedetomidine (2.5 µg per kg)
administered 30 minutes before MRI. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1.Children aged 1 to 10 years of either sex
2.American Society of Anaesthesiologists, physical status 1 to 3
3.Scheduled for elective, non contrast brain MRI |
|
| ExclusionCriteria |
| Details |
1.Refusal of consent by parents/guardians Recent 2.upper respiratory tract infection (less than 2 weeks)
3.Inadequate fasting status (solids less than 6h, clear fluids less than 2h)
4.Nasal deformity/obstruction (e.g. Choanal atresia)
5.Anticipated difficult airway
6.Significant systemic disease or contraindication to study drugs |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Time to onset of adequate sedation which will be measured as the interval (in minutes) from
intranasal dexmedetomidine administration to achievement of a University of Michigan
Sedation Scale (UMSS) score more than or equal to 3 in both groups. |
Time after administration of Intranasal Dexmedetomidine in minutes at which University of Michigan Sedation Scale score more than or equal to 3 achieved. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Compliance during IV cannulation, assessed using the Children’s Emotional
Manifestation Scale (CEMS) in both groups. |
After administration of oral Melatonin when the UMSS Score of more than or equal to 3 will be achieved. |
Success rate of sedation, proportion of children achieving successful sedation, defined as completion of MRI without intravenous (IV) rescue sedation and maintaining a UMSS
of more than or equal to 3 throughout imaging, compared between the two groups. |
Immediately after completion of MRI |
| Requirement for rescue sedation, number of patients requiring IV rescue sedation and the total cumulative dose (µg/kg) of rescue sedation administered during MRI, compared between the two groups. |
During MRI |
| Movement episodes during MRI via the Movement Score |
During MRI |
| Monitoring of parameters including HR, NIBP, Oxygen Saturation(baseline,every 5 min) |
During MRI |
Parental satisfaction will be assessed post-procedure using a 5-point Likert Scale in both
groups. |
At the time of discharge |
Time to discharge measured as the interval (in minutes) from completion of MRI to
achievement of a Modified Aldrete Score more than or equal to 9, compared between the two groups. |
After completion of MRI |
Following Adverse events will be noted: hypotension, bradycardia,
desaturation, airway obstruction, prolonged sedation, Emergence agitation/delirium via
the Paediatric Anaesthesia Emergence Delirium Scale (PAED) scale |
After administration of Oral melatonin, During MRI, After the completion of MRI |
| Total Sedation Time from UMSS more than or equal to 3 to Modified Aldrete Score more than or equal to 9 |
After administration of the oral Melatonin to before the discharge of the patient |
| Total hospital stay post-MRI |
After Completion of MRI |
|
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
11/02/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
11/02/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Magnetic Resonance Imaging (MRI) in children requires complete immobility in a noisy and confined environment, which is often not achievable without sedation. Intranasal dexmedetomidine is an effective, non-invasive sedative agent that provides deep sedation while preserving spontaneous respiration, yet higher doses may prolong recovery or cause haemodynamic effects. However, intravenous rescue sedation may be required in some children. Oral melatonin, a natural hormone regulating circadian rhythm, has also been used safely in paediatric practice as a premedication and in combination with other sedatives, where it has caused anxiolysis, smoother recovery, and reduced emergence agitation. Previous attempts to combine dexmedetomidine with agents like midazolam, ketamine or propofol have been constrained by adverse effects, but combining it with melatonin offers a more promising and complementary approach. However, the role of melatonin as a premedication with intranasal dexmedetomidine in paediatric MRI has been evaluated sparingly. Whether melatonin enhances sedation success, reduces the requirement of rescue intravenous sedation, shortens onset time, and improves recovery when combined with intranasal dexmedetomidine remains unknown. This knowledge gap forms the basis of the present study. We hypothesize that oral melatonin given as a premedication to intranasal dexmedetomidine will increase the rate of successful MRI sedation (completion without IV rescue and with UMSS of more than or equal to 3), shorten the onset time to adequate sedation, and improve recovery characteristics, compared with intranasal dexmedetomidine alone.
|