Comparison of Melatonin and Triclofos for Inducing Sedation for Sleep EEG in Children: An open labeled Randomized Controlled Trial
Phase 4
- Conditions
- Health Condition 1: G89-G99- Other disorders of the nervous system
- Registration Number
- CTRI/2024/01/061446
- Lead Sponsor
- Dr Poonam Dalal
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Children aged 1-14years
2. Children with an indication of sedation for EEG; either for sleep EEG or where co-operation is needed to do EEG, like in young children and children with behavioral disorders and/or developmental delay.
Exclusion Criteria
1. A previously diagnosed sleep disorder
2. Hypersensitivity to either of the drugs or one of its substances
3. Inability to comply with the study protocol
4. Consent not given by parents/caregivers for enrollment as well as randomization.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparison of Melatonin & Triclofos for Inducing Sedation for Sleep EEG in Children. <br/ ><br>percentage of children with successful EEG recording with first dose of melatonin or triclofos.Timepoint: 4hours
- Secondary Outcome Measures
Name Time Method The other outcomes will be the proportion of children with developmental/behavioral problems in whom sleep EEG could be recorded, proportion with successful sleep EEG after repeat dose of these medications, the yield of epileptiform abnormalities, percentage of children with artifacts in sleep EEG related to sedatives.Timepoint: 4hours