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The comparison of melatonin and chloral hydrate on sleep induction for electroencephalography recording

Comparison of melatonin and chloral hydrate on sleep induction for recording Electroencephalography in children aged six months to five years old

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20221227056944N1
Enrollment
78
Registered
2023-05-17
Start date
2021-11-14
Completion date
Unknown
Last updated
2023-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Seizure. Epilepsy and recurrent seizures

Interventions

Intervention 1: Intervention group 1: Melatonin tablets (Three milligrams) from Razak Pharmaceutical Company with a dose of 0.4 Milligram per Kilogram, dissolved in water, were given to the patients o

Sponsors

Gorgan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Months to 5 Years

Inclusion criteria

Inclusion criteria: The existence of seizures or other seizure-like attacks requiring electroencephalography examination Age between six months to five years Class one and two of the American Society of Anesthesiologists (ASA) classification Complete relative sleep deprivation

Exclusion criteria

Exclusion criteria: Severe allergic reaction to Chloral hydrate and Melatonin History of recent head injury Use of Sedation drugs in the last two days Other severe systemic diseases

Design outcomes

Primary

MeasureTime frame
Sedation induction. Timepoint: From the beginning to the end of sedation. Method of measurement: Ramsay Sedation Score to determine success or failure of sedation.

Secondary

MeasureTime frame
Sedation onset. Timepoint: Sedation score 4 and above based on Ramsay Sedation Score (RSC). Method of measurement: Ramsay Sedation Score.;Sedation Duration. Timepoint: The interval between complete sedation and withdrawal from sedation. Method of measurement: Steward Recovery Score.;Recovery time. Timepoint: The interval between complete withdrawal from sedation and complete recovery. Method of measurement: Calculate time in hours and minutes using a clock.;Side effects. Timepoint: After recovery. Method of measurement: Patient assessment.;Epileptiform discharges in Electroencephalography (EEG). Timepoint: After Electroencephalography (EEG) recording. Method of measurement: Examination by a neurologist.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSeyed-Ahmad Hosseini

Gorgan University of Medical Sciences

parnianah@yahoo.com+98 17 3244 0721

Outcome results

None listed

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