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To Compare the Effectiveness and Safety of oral syrup Melatonin versus oral syrup Triclofos Sodium for the Sedation of Children in short pediatric procedures

To Compare the Effectiveness and Safety of Melatonin versus Triclofos Sodium in Procedural Sedation of Children - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/10/096551
Enrollment
70
Registered
2025-10-29
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Sedation induced by oral medication, Melatonin and Triclofos Sodium, respectively: Randomized administration of drugs to induce sedation for elective procedures. Melatonin: Syrup Mela

Sponsors

Dr Ruchika Myrtle Calton
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children aged 3 to 18 years of age. Children posted for elective procedures (BERA, EEG, and CT scan)

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
compare time taken to achieve effective sedationTimepoint: level of sedation monitoring to be done for each 5 minute for one hour after giving drug.

Secondary

MeasureTime frame
compare the safety profile of both the drugsTimepoint: 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.

Countries

India

Contacts

Public ContactRuchika Myrtle Calton

Christian Medical College Ludhiana

drsmonika@gmail.com9814861205

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026