Comparison of Hydroxyzine with Triclofos for achieving sleep in children for EEG recording
Phase 4
Completed
- Conditions
- Health Condition 1: G40- Epilepsy and recurrent seizures
- Registration Number
- CTRI/2021/04/033074
- Lead Sponsor
- Christian Medical College Fluid Research Fund
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 228
Inclusion Criteria
Children in whom EEG recording was not possible under natural sleep
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Acceptability of SedationTimepoint: Technician - Likert Scale <br/ ><br>Neurologist - VAS score <br/ ><br>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