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Effect of Sedation on sleep EEG recording

Effect of Triclofos versus Melatonin on sleep EEG recording- A Prospective Randomised Controlled study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/04/041952
Enrollment
150
Registered
2022-04-19
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: G938- Other specified disorders of brain

Interventions

Intervention1: Effect of Triclofos on sleep EEG recording: Dose - 50mg/kg/dose, orally Frequency - once, may be repeated after 2hr if child is not sedated Route of administartion- oral Duration- once

Sponsors

Command Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children (1-10 years) referred for sleep EEG and required medication for induction of sleep were enrolled and were randomly divided in two groups of triclofos and melatonin for sedation

Exclusion criteria

Exclusion criteria: Patients who had hypersensitivity to triclofos or melatonin or hepatic or renal impairment.

Design outcomes

Primary

MeasureTime frame
To compare the effect of triclofos versus melatonin on sleep EEG recording for children between 1 -10 years of ageTimepoint: Baseline and after 24hrs of EEG recording—

Secondary

MeasureTime frame
1. To measure mean sleep onset latency in both the group 2. To measure sleep duration and requirement of 2nd dose of drug 3. To study the side effect of both the drugsTimepoint: 24-48hrs—

Countries

India

Contacts

Public ContactDr Rahul Sinha

Command Hospital

drrahul_2000@yahoo.com8800630109

Outcome results

None listed

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