A study to compare effectiveness of oral Triclofos versus Melatonin for inducing sedation in children for recording EEG in a Tertiary care centre: A Randomised Control Trial

Effectiveness of oral Triclofos versus Melatonin for inducing sedation in children for recording EEG in a Tertiary care centre: A Randomised Control Trial - Nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/10/059031

Enrollment

Registered

2023-10-23

Start date

Unknown

Completion date

Unknown

Last updated

2023-11-13

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

Conditions

Health Condition 1: F01-F99- Mental, Behavioral and Neurodevelopmental disorders

Interventions

Intervention1: Melatonin: First dose is 5mg per kg body weight. If the child does not sleep after an hour, a second dose of 5 mg/kg body weight will be given followed by waiting for another hour for s

Eligibility

Inclusion criteria

Inclusion criteria: Provisional diagnosis of Epilepsy, Behavioural disorders, Neurodevelopmental disorders, Learning disabilities, according to DSM 5 Criteria

Exclusion criteria

Exclusion criteria: 1.Patients having significant comorbidities or life threatening conditions 2. Consent to participate not given 3. Patients having adverse reactions to Triclofos or Melatonin 4.Patients having significant respiratory or cardiac disease

Design outcomes

Primary

Measure	Time frame
Sedation assessed by Richmond Agitation Sedation ScaleTimepoint: 60 min	—

Secondary

Measure	Time frame
Adverse drug reactionTimepoint: 8 hour;Duration of sleepTimepoint: 2 hrs;Interference with EEGTimepoint: 2 hrs	—

Countries

India

Contacts

Public ContactDrSukanto Sarkar

AIIMS Kalyani

sukanto.psy@aiimskalyani.edu.in9655489210

Outcome results

None listed

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