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Comparison of Hydroxyzine with Triclofos for achieving sleep in children for EEG recording

Hydroxyzine versus Triclofos for sedation for Electroencephalography recording in children- a non-inferiority randomized controlled trial - HYTEC

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/04/033074
Enrollment
230
Registered
2021-04-23
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: G40- Epilepsy and recurrent seizures

Interventions

Intervention1: Hydroxyzine: Syrup Hydroxyzine will be administered for sedation for Electroencephalography recording in children Control Intervention1: Triclofos: Syrup Triclofos will be administered

Sponsors

Christian Medical College Fluid Research Fund
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children in whom EEG recording was not possible under natural sleep

Exclusion criteria

Exclusion criteria: 1. Previous allergic reaction to the agents 2. Concurrent use of other anti-histaminic preparations for treatment 3. Any marked hepatic or renal impairment, cardiac, pulmonary or neuromuscular conditions that preclude sedation 4. Intercurrent illness

Design outcomes

Primary

MeasureTime frame
Successful EEG completion with no arousal in the study periodTimepoint: Successful EEG completion will be considered as obtaining a sleep record of at least 40 minutes

Secondary

MeasureTime frame
Acceptability of SedationTimepoint: Technician - Likert Scale Neurologist - VAS score Caregiver - Likert scale;Need for second dose of sedative agentTimepoint: After one hour;Ramsay Sedataion ScoreTimepoint: equal to or more than four;Time taken for sedationTimepoint: Time from drug administration to onset of sleep

Countries

India

Contacts

Public ContactNarmadham K B

Christian Medical College

narmadham.bharathi@gmail.com9600703964

Outcome results

None listed

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