Performance of diagnostic medical procedures needs patient’s cooperation that is often refused by children. The EEG procedure is especially not well tolerated by children with developmental disa Epilepsy Electroencephalography Melatonin Sleep deprivation Chloral hydrate Sleep onset latency Duration of sleep
Conditions
Interventions
Melatonin only group
Do not have sleep deprivation.
The melatonin is contained in capsule (Swanson®,
manufactured by Swanson Health Products in the USA 3mg/capsule). When giving to the patients,
the capsule will be removed then dissolve 3mg melatonin powder with the water. If the patients do not sleep,
they would be received second dose of melatonin in the same dose apart from first dose 60 minutes.
If the patients have the hypersensitivity type I allergy symptoms (acute urticaria or anaphylaxis) or
the patients will be treated and the study will be stopped.
,Combined melatonin and sleep deprivation group
The patients must follow sleep deprivation protocol.
Sleep deprivation protocol
The night
patients have to sleep 2 hours later than usual and wake up at the usual schedule. If the patients have EEG schedule in the afternoon,
they do not sleep during the day.
Do not stop the antiepileptic drugs and others patients drugs.
Refrain from food and drink at least 4 hours before the EEG procedure.
The melatonin is contained in ca
they will received second dose of melatonin in the same dose apart from first dose 60 minutes.
If the patients have the hypersensitivity type I allergy symptoms (acute urticaria or anaphylaxis) or oth
the patients will be treated and the study will be stopped.
,combined chloral hydrate and sleep deprivation group
The patients must follow sleep de
Active Comparator Drug,Active Comparator Drug,Active Comparator Drug
Given melatonin before EEG recording,Given melatonin with done the sleep deprivation protocol before EEG recording,Given chloral hydrate with done the sleep deprivation protocol before EEG recording
Sponsors
The Ratchadapiseksompotch Fund (RA 62/064)
Eligibility
Sex/Gender
All
Age
1 Years to 5 Years
Inclusion criteria
Inclusion criteria: -Patients whom were consulted for EEG recording at King Chulalongkorn Memorial hospital -Age between 1-5 years or older but do not co-operate
Exclusion criteria
Exclusion criteria: -History of allergy to chloral hydrate or melatonin patients -Patients have current respiratory infection problems or abnormal -respiratory signs and symptoms such as dyspnea which risk to -respiratory insufficiency -Alteration of consciousness patients -Patients who can not follow the sleep deprivation protocol children nor parents factors -Enteral feeding contraindicated patients -Patients who have clinically seizure during the EEG performance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compare the efficacy of melatonin versus melatonin and sleep deprivation versus chloral hydrate and 8 months time to sleep, duration of sleep | — |
Secondary
| Measure | Time frame |
|---|---|
| Factors associated with sleep duration and sleep latency 8 months multivariate group comparison | — |
Countries
Thailand
Contacts
Public ContactKornkamol Holsakul
King Chulalongkorn Memorial Hospital
Outcome results
None listed