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Comparison of oral Midazolam, Clonidin and Melatonin with Chloral hydrate for recording sleep EEG in children

Comparison of oral Midazolam, Clonidin and Melatonin with Chloral hydrate for recording sleep EEG in children

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201106286907N1
Enrollment
400
Registered
2011-10-01
Start date
2011-01-01
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Induction of sedation for recording sleep EEG. Epilepsy, unspecified

Interventions

Intervention 1: Midazolam prescribed as oral solution(Amsed oral liquid 2.5 mg in 1 ml) 0.5 mg/kg/dose . Intervention 2: Clonidin prescribed as tablet( 0.2mg) 2-4 microgram/kg/dose . Intervention 3: C
Treatment - Drugs
Midazolam prescribed as oral solution(Amsed oral liquid 2.5 mg in 1 ml) 0.5 mg/kg/dose .
Clonidin prescribed as tablet( 0.2mg) 2-4 microgram/kg/dose .
Chloral hydrate prescribed as solution of 10% 1cc/kg/dose
Parents informed that to put their children to sleep 2 h later than the usual time , awaken them at 6.00 am and not to let them fall asleep until the time of EEG recording . Melatonin prescribed as Sy

Sponsors

Tehran University of Medical Sciences
Lead Sponsor
Behinpad Company
Collaborator

Eligibility

Sex/Gender
All
Age
No minimum to 6 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria; non cooperative children aged between 1 month to 72 months and patients that refered for Sleep EEG. Exclusion criteria ; Hypersensensivity to Chloral hydrate, Melatonin, Midazolam and Clonidin; hepatic or renal diseases; severe cardiac disease; peptic ulcer; severe tonsillar or adenoid hypertrophy and being under treatment with medications that have serious interaction with these drugs .

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Time to sleep, Sleep duration and time to awakeness. Timepoint: Immediately after consumption. Method of measurement: Examination.

Secondary

MeasureTime frame
Possible side effect of drugs. Timepoint: While treatment. Method of measurement: Questionaire.

Countries

Iran (Islamic Republic of)

Outcome results

None listed

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