| CTRI Number |
CTRI/2025/10/096551 [Registered on: 29/10/2025] Trial Registered Prospectively |
| Last Modified On: |
27/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Compare the Effectiveness and Safety of oral syrup Melatonin versus oral syrup Triclofos Sodium for the Sedation of Children in short pediatric procedures |
|
Scientific Title of Study
|
To Compare the Effectiveness and Safety of Melatonin versus Triclofos Sodium in Procedural Sedation of Children |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ruchika Myrtle Calton |
| Designation |
Junior Resident |
| Affiliation |
Christian Medical College Ludhiana |
| Address |
C/O Department of Pediatrics, Christian Medical College Ludhiana, Brown Road, Ludhiana, Punjab
Ludhiana
PUNJAB
141008
India |
| Phone |
8427810666 |
| Fax |
|
| Email |
ruchicalton@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Monika Sharma |
| Designation |
Professor |
| Affiliation |
Christian Medical College Ludhiana |
| Address |
C/O Department of Pediatrics, Christian Medical College Ludhiana, Brown Road, Ludhiana, Punjab, 141008
Department of Pediatrics, Christian Medical College Ludhiana, Brown Road, Ludhiana, Punjab, 141008
Ludhiana
PUNJAB
141008
India |
| Phone |
9814861205 |
| Fax |
|
| Email |
drsmonika@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ruchika Myrtle Calton |
| Designation |
Junior Resident |
| Affiliation |
Christian Medical College Ludhiana |
| Address |
C/O Department of Pediatrics, Christian Medical College Ludhiana, Brown Road, Ludhiana, Punjab
Ludhiana
PUNJAB
141008
India |
| Phone |
8427810666 |
| Fax |
|
| Email |
ruchicalton@yahoo.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Ruchika Myrtle Calton |
| Address |
C/O Department of Pediatrics, Christian Medical College Ludhiana, Brown Road, Ludhiana, Punjab, 141008 |
| Type of Sponsor |
Other [self] |
|
|
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 Ruchika Myrtle Calton |
Christian Medical College, Ludhiana |
C/O Department of Pediatrics, Christian Medical College Ludhiana, Brown Road, Ludhiana, Punjab
Ludhiana
PUNJAB |
08427810666
ruchicalton@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Christian Medical College, Ludhiana |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
for elective procedures (BERA, EEG, CT Scan) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Effectiveness |
to compare the effectiveness of sedation provided using the RASS score |
| Comparator Agent |
Safety |
to compare safety of sedation provided by monitoring child after administration of drug, during and after procedures |
| Intervention |
Sedation induced by oral medication, Melatonin and Triclofos Sodium, respectively |
Randomized administration of drugs to induce sedation for elective procedures.
Melatonin:
Syrup Melatonin will be administered orally according to weight. 10 kg: 0.3 mg/kg,
10-15kg: 3 mg, and 15 kg: 6mg.
• Maximum dose according to age: 3-6 year: 10 mg, 6 years: 20 mg.
• Initial Dose to be given 30 mins prior to procedure.
• Dose can be repeated if sleep not obtained within 40 mins of initial dose.
Triclofos Sodium:
• Syrup Triclofos will be administered orally at an initial dose of 50mg/kg.
• Maximum dose according to age: 1-5 years age: 250-500mg, 6-12years: 500-1000 mg,
11-18years: till 2000 mg.
• Initial Dose To be given 30mins prior to procedure.
• Dose can be repeated if sleep not obtained within 40 mins of initial dose. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Children aged 3 to 18 years of age.
Children posted for elective procedures (BERA, EEG, and CT scan)
|
|
| ExclusionCriteria |
| Details |
Children with Weight less than 5 Kilograms. High risk children defined by ASA-PS Score more than or equal to 3. History of adverse events during prior sedation with either of the study drugs. Invasive procedures such as biopsies and aspirations or tapping. Long procedures more than 60 mins duration. requiring long sedation. Children already on sedation for ventilation.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| compare time taken to achieve effective sedation |
level of sedation monitoring to be done for each 5 minute for one hour after giving drug. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| compare the safety profile of both the drugs |
vital monitoring to be done for each 5 minute for one hour after giving drug. then for each 5 minute for one hour after sedation achieved. |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
10/11/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| 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 Applicable |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [ruchicalton@yahoo.in].
- For how long will this data be available start date provided 15-05-2025 and end date provided 15-10-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
To compare the effectiveness and safety of the drugs Melatonin and Triclofos Sodium in the procedural sedation of children. Oral form of each medications will be given to respective groups of equal number of participants and the quality and time required to achieve sedation will be recorded. also, the vital monitoring of participants will be done after giving drug, once sedation is achieved and during the procedure to assess the safety profile of the drugs. |