To compare the ease of inducing sleep in children posted for EEG between Intranasal Dexmedetomidine, oral Triclofos and oral Melatoni
- Conditions
- Health Condition 1: G40- Epilepsy and recurrent seizures
- Registration Number
- CTRI/2023/11/059517
- Lead Sponsor
- Child Neurology Division, Department of pediatrics, AIIMS New Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1.Children of either sex aged 1-12 years scheduled to have a sleep deprived sleep EEG recording at Pediatric EEG lab, Department of Pediatrics, AIIMS.
•Sleep deprived is defined as letting the child sleep 2 hours later and waking up 2 hours earlier than his usual sleep and awake time.
•Sleep deprivation will be classified as
- no sleep deprivation ( <30 mins)
- partial sleep deprivation (30 mins-4hr)
- adequate sleep deprivation ( > 4)
1.Children suffering from an acute upper respiratory tract infection.
2.Children already diagnosed with sleep related movement disorders.
3.Children with previously diagnosed cardiac rhythm disorder or heart block.
4.Children diagnosed with acute cerebrovascular event within the last six months.
5.Children who have received any sedative medication (including investigation drugs) other than antiepileptics within the last 48 hours
6.Children with status epilepticus within the last 48 hours
7.Weight < 8 kg and > 40 kg
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the sleep onset latency (1) between intranasal dexmedetomidine with oral triclofos, (2) oral melatonin with oral triclofos and (3) intranasal dexmedetomidine with oral melatonin, when used as procedural sedative for drug induced sleep EEG in children 01-12 years. <br/ ><br>Timepoint: Baseline and 24 hours
- Secondary Outcome Measures
Name Time Method (1)To compare the sleep duration between intranasal dexmedetomidine, oral Melatonin & oral Triclofos <br/ ><br>(2)To compare the proportion of children with good quality EEG recording between intranasal dexmedetomidine, oral triclofos & oral melatonin <br/ ><br>(3)To compare proportion of children achieving adequate sedation with first dose between intranasal dexmedetomidine, oral triclofos & oral melatonin. <br/ ><br>(4)To compare the proportion of children with abnormal EEG between intranasal dexmedetomidine, oral melatonin & oral triclofos <br/ ><br>(5)To compare immediate & short-term adverse effects (24 hrs) between intranasal dexmedetomidine, oral melatonin & oral triclofos <br/ ><br>(6)To compare parent satisfaction rating on a 5-point Likert scale between intranasal dexmedetomidine, oral melatonin & oral triclofos <br/ ><br>Timepoint: Baseline & 24 hour