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comparison of 2 medicines: Melatonin and Triclofos to achieve sleep for EEG

Randomized controlled trial to compare the efficacy and tolerability of melatonin with triclofos in inducing sleep for pediatric electroencephalograms

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/01/016917
Enrollment
202
Registered
2019-01-04
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: G409- Epilepsy, unspecified

Interventions

Intervention1: Melatonin: Syrup or Tablet melatonin will be given to achieve sedation Control Intervention1: Triclofos: Syrup will be given to achieve sedation

Sponsors

Bharati Hospital research Centre Pune
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Al children coming for EEG who meet the age criteria

Exclusion criteria

Exclusion criteria: Children with acute illness, chronic heart disease, hepatic or renal disease, myopathy or had a prior complication on sedation

Design outcomes

Primary

MeasureTime frame
1. Number of EEG successfully completed 2. Sleep onset latency 3. Period of sleep 4. Incidence of adverse eventsTimepoint: 1. Number of EEG successfully completed at the end of procedure, usually half an hour 2. Sleep onset latency in minutes after onset of EEG procedure 3. Period of sleep in minutes, during and fater EEG 4. Incidence of adverse events within first 24 hours of drug administration

Secondary

MeasureTime frame
1. Yield of epileptiform discharges on EEG 2. Need for second dose to achieve sedation 3. Artifacts in EEGTimepoint: Till successful completion of EEG

Countries

India

Contacts

Public ContactSiddhant Lalwani

Bharati Vidyapeeth Deemed to be University Medical College, Pune

kavisri1970@gmail.com09850825791

Outcome results

None listed

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