Health Condition 1: G40- Epilepsy and recurrent seizures Health Condition 2: Z728- Other problems related to lifestyle
Conditions
Interventions
Intervention1: Oral Melatonin: Melatonin plays an important role in regulation of circadian rhythms. Due to its hypnotic properties and ability to reduce sleep latency in children, Melatonin has been
Sponsors
Dr Prashant Jauhari
Eligibility
Inclusion criteria
Inclusion criteria: 1. Children of either sex aged 1-8 years scheduled to have a sleep deprived sleep EEG recording at Pediatric EEG lab, Department of Pediatrics, AIIMS 2. Children who are sleep deprived as per the guidelines mentioned in the methodology section
Exclusion criteria
Exclusion criteria: 1. Children suffering from an acute upper respiratory tract infection 2. Children diagnosed with autism, ADHD or significant behavioural disorders on CBCL 3. Children already diagnosed with sleep related movement disorders 4. Children who have received any sedative medication (including investigation drugs) other than antiepileptics within the last 48 hours 5. Parents refusing consent for enrolment in the study 6. Children with status epilepticus within the last 48 hours
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sleep duration in minutes as measured by Paediatric Sedation State Scale. Timepoint: after 1st dose of the drug administered | — |
Secondary
| Measure | Time frame |
|---|---|
| 5-point likert scale for parental satisfactionTimepoint: within 24 hours after performing EEG;Adequate sedation defined by achievement of Pediatric sedation state scale level 2 or less in minutesTimepoint: after first dose of drug administered;Drowsiness period in minutes as measured by Paediatric Sedation State Scale.Timepoint: after first dose of drug administered;Percentage of children having adverse effects within 24 hours after performing EEG (telephonically).Timepoint: within 24 hours after performing EEG;Percentage of children requiring second dose in each group.Timepoint: 30 minutes after administring first dose;Quality of EEG assessed by a self-designed EEG scoring systemTimepoint: after 20 minutes of EEG recording as per protocol | — |
Countries
India
Contacts
Public ContactMiss Divya Sree Fachchi
All India Institute of Medical Sciences, New Delhi
Outcome results
None listed