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Melatonin and Triclofos Sodium comparison to produce sleep in children during CT

Oral Melatonin vs Oral Triclofos sodium for sedation during computerised tomography in children: A single Blinded Randomised Controlled Trial. - Nil

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/06/053793
Enrollment
120
Registered
2023-06-13
Start date
Unknown
Completion date
Unknown
Last updated
2023-06-26

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

Conditions

Health Condition 1: G01- Meningitis in bacterial diseases classified elsewhere

Interventions

Intervention1: Randomized Parallel Group Trial: 1. Children Will Be Enrolled After Fulfilling Inclusion And Exclusion Criteria. 2. Randomization Into Two Groups , Group A: Will Receive Oral Melatonin

Sponsors

Dr Janhavi Sushil Zambani
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) All children between 6 months to 12 years admitted in Paediatric Ward requiring Brain CT Scan. 2) These children should be in American Society of Anaesthesiology (ASA) class 1 or 2.

Exclusion criteria

Exclusion criteria: 1) Presence of gastritis, any other serious systemic disease, or severe systemic reaction. 2) Children receiving sedative-hypnotic agents within the past 48 hours. 3) Children with acute respiratory illnesses, chronic severe respiratory problems, severe cardiac, renal or hepatic diseases. 4) Those who were already on Melatonin or Trichlofos Sodium were excluded. 5) Patients whose parents didnâ??t give consent.

Design outcomes

Primary

MeasureTime frame
To compare efficacy of oral melatonin with oral Triclofos Sodium for sedation during elective computerized tomography of the brain in children.Timepoint: December 2024

Secondary

MeasureTime frame
1.TO COMPARE TIME OF ADMINISTRATION TO ADEQUATE SEDATION BETWEEN TWO DRUGS 2.TO COMPARE TOTAL STAY TIME BETWEEN TWO GROUPS 3.TO STUDY ADVERSE EFFECTSTimepoint: AT THE START AND END OF CT

Countries

India

Contacts

Public ContactDr Janhavi Sushil Zambani

GMC Aurangabad

SMITA.MUNDADA@gmail.com9224287215

Outcome results

None listed

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