Study to identify the most effective method of inducing sleep during EEG for children between 6 months and 12 years undergoing sleep EEG

Randomized Controlled Trial to identify the most effective method of sleep induction during EEG in children 6m-12years undergoing sleep EEG

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/05/042479

Enrollment

477

Registered

2022-05-12

Start date

Unknown

Completion date

Unknown

Last updated

2023-05-29

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

Conditions

Health Condition 1: G40- Epilepsy and recurrent seizures

Interventions

Intervention1: Arm A: Sleep Deprivation and Syrup Trichlorofos (@50mg/kg/dose) Intervention2: Arm B: Sleep deprivation and Syrup melatonin in a dose of 3mg for those who weigh â?¤15kg and 6mg for thos

Eligibility

Inclusion criteria

Inclusion criteria: All children who are booked for sleep EEG by the treating physician or those who are unable to keep still for an awake EEG

Exclusion criteria

Exclusion criteria: Individuals/ caregivers not consenting for participating in the study

Design outcomes

Primary

Measure	Time frame
Compare the efficacy of melatonin with sleep deprivation, trichlorofos with sleep deprivation, and sleep deprivation alone for inducing sleep among 6 months to 12 years old children undergoing sleep EEGTimepoint: At completion of EEG At 24h	—

Secondary

Measure	Time frame
Compare the quality of EEG recordingsTimepoint: During EEG analysis after recording;Determine sleep duration with each interventionTimepoint: While undergoing EEG and for 24 hours after administration of drug;Determine sleep onset latency with each interventionTimepoint: While undergoing EEG;Determine the number of patients needing a second dose of the drug or alternative drugTimepoint: While undergoing EEG;Estimate drug-related adverse eventsTimepoint: Over the 24 hours after drug administration	—

Measure

Time frame

Compare the quality of EEG recordingsTimepoint: During EEG analysis after recording;Determine sleep duration with each interventionTimepoint: While undergoing EEG and for 24 hours after administration of drug;Determine sleep onset latency with each interventionTimepoint: While undergoing EEG;Determine the number of patients needing a second dose of the drug or alternative drugTimepoint: While undergoing EEG;Estimate drug-related adverse eventsTimepoint: Over the 24 hours after drug administration

—

Countries

India

Contacts

Public ContactPriyamol TM

Armed Forces Medical College

dramitdevgan@gmail.com9836111939

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 5, 2026