To compare the ease of inducing sleep in children posted for EEG between Intranasal Dexmedetomidine, oral Triclofos and oral Melatonin

To compare the efficacy of Intranasal Dexmedetomidine vs oral Melatonin vs oral Triclofos as procedural sedative for drug induced sleep EEG in children: A double-blind, parallel design, randomized clinical trial - NIL

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/11/059517

Enrollment

195

Registered

2023-11-03

Start date

Unknown

Completion date

Unknown

Last updated

2024-01-22

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: Dexmedetomidine: Intranasal dexmedetomidine would be given as per weight band ranging from 1.75 to 2.25 mcg per kg. Second dose may be repeated if the child does not sleep after 3o minu

Eligibility

Inclusion criteria

Inclusion criteria: 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 ( - partial sleep deprivation (30 mins-4hr) - adequate sleep deprivation ( > 4)

Exclusion criteria

Exclusion criteria: 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 40 kg

Design outcomes

Primary

Measure	Time frame
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. Timepoint: Baseline and 24 hours	—

Secondary

Measure	Time frame
(1)To compare the sleep duration between intranasal dexmedetomidine, oral Melatonin & oral Triclofos (2)To compare the proportion of children with good quality EEG recording between intranasal dexmedetomidine, oral triclofos & oral melatonin (3)To compare proportion of children achieving adequate sedation with first dose between intranasal dexmedetomidine, oral triclofos & oral melatonin. (4)To compare the proportion of children with abnormal EEG between intranasal dexmedetomidine, oral melatonin & oral triclofos (5)To compare immediate & short-term adverse effects (24 hrs) between intranasal dexmedetomidine, oral melatonin & oral triclofos (6)To compare parent satisfaction rating on a 5-point Likert scale between intranasal dexmedetomidine, oral melatonin & oral triclofos Timepoint: Baseline & 24 hour	—

Measure

Time frame

(1)To compare the sleep duration between intranasal dexmedetomidine, oral Melatonin & oral Triclofos (2)To compare the proportion of children with good quality EEG recording between intranasal dexmedetomidine, oral triclofos & oral melatonin (3)To compare proportion of children achieving adequate sedation with first dose between intranasal dexmedetomidine, oral triclofos & oral melatonin. (4)To compare the proportion of children with abnormal EEG between intranasal dexmedetomidine, oral melatonin & oral triclofos (5)To compare immediate & short-term adverse effects (24 hrs) between intranasal dexmedetomidine, oral melatonin & oral triclofos (6)To compare parent satisfaction rating on a 5-point Likert scale between intranasal dexmedetomidine, oral melatonin & oral triclofos Timepoint: Baseline & 24 hour

—

Countries

India

Contacts

Public ContactDr Shankar Dhungel

AIIMS, NEW DELHI

pjauhari0@gmail.com9914521820

Outcome results

None listed

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