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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.


 
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