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Comparison of Melatonin and Triclofos for Inducing Sedation for Sleep EEG in Children: An open labeled Randomized Controlled Trial

Comparison of Melatonin and Triclofos for Inducing Sedation for Sleep EEG in Children: An open labeled Randomized Controlled Trial - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/01/061446
Enrollment
100
Registered
2024-01-15
Start date
Unknown
Completion date
Unknown
Last updated
2024-01-22

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

Conditions

Health Condition 1: G89-G99- Other disorders of the nervous system

Interventions

Intervention1: Comparison of Melatonin and Triclofos for Inducing Sedation for Sleep EEG in Children: An open labeled Randomized Controlled Trial: The study sample would be randomised into two groups.

Sponsors

Dr Poonam Dalal
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Children aged 1-14years 2. Children with an indication of sedation for EEG; either for sleep EEG or where co-operation is needed to do EEG, like in young children and children with behavioral disorders and/or developmental delay.

Exclusion criteria

Exclusion criteria: 1. A previously diagnosed sleep disorder 2. Hypersensitivity to either of the drugs or one of its substances 3. Inability to comply with the study protocol 4. Consent not given by parents/caregivers for enrollment as well as randomization.

Design outcomes

Primary

MeasureTime frame
Comparison of Melatonin & Triclofos for Inducing Sedation for Sleep EEG in Children. percentage of children with successful EEG recording with first dose of melatonin or triclofos.Timepoint: 4hours

Secondary

MeasureTime frame
The other outcomes will be the proportion of children with developmental/behavioral problems in whom sleep EEG could be recorded, proportion with successful sleep EEG after repeat dose of these medications, the yield of epileptiform abnormalities, percentage of children with artifacts in sleep EEG related to sedatives.Timepoint: 4hours

Countries

India

Contacts

Public ContactDr Vatan

Pt.B.D.Sharma PGIMS Rohtak

drpoonam12@yahoo.com9992168645

Outcome results

None listed

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