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chloral hydrate, combination of chloral hydrate - promethazine and combination of chloral hydrate - hydroxyzine in sedation induction for electroencephalography of children

Comparison of efficacy and safety of chloral hydrate, combination of chloral hydrate - promethazine and combination of chloral hydrate - hydroxyzine in sedation induction for electroencephalography of children

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT201204262639N8
Enrollment
90
Registered
2012-07-28
Start date
2012-04-20
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

epilepsy. Epilepsy and paroxysmal disorders

Interventions

Intervention 1: combibation of 1mg/kg hydroxyzine and 40 mg/kg of chloral hydrate. Intervention 2: combination 1mg/kg promethazine and 40 mg/kg of chloral hydrate. Intervention 3: single dose 40 m
Treatment - Other
combibation of 1mg/kg hydroxyzine and 40 mg/kg of chloral hydrate
combination 1mg/kg promethazine and 40 mg/kg of chloral hydrate
single dose 40 mg/kg of chloral hydrate

Sponsors

Ali-ebn-Abitaleb School of Medicine, Islamic Azad University, Yazd Branch, Yazd, Iran
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 7 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: 1. Children who are referred to EEG center but don’t obey, 2. Age 1-7 years old 3. Class 1 or 2 of ASA Exclusion criteria: 1. Presence of gastritis or any other serious systemic diseases 2. Severe systemic reaction 3. History of allergy to drug 4. The patient does not use the drug completely

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Success in recording of EEG. Timepoint: every 15 minutes. Method of measurement: clinical exam.;Adequate sedation (Ramsay score of four is attained). Timepoint: every 15 minutes. Method of measurement: clinical exam.

Secondary

MeasureTime frame
Total stay time in EEG unit. Timepoint: every 30 minutes. Method of measurement: asking from parents.;Side effects. Timepoint: every 15 minutes. Method of measurement: clinical exam.;Time to induction of adequate sedation. Timepoint: every 15 minutes. Method of measurement: clinical exam.;Caregiver’s satisfaction. Timepoint: after one hour of drug use. Method of measurement: asking from caregiver.

Countries

Iran (Islamic Republic of)

Outcome results

None listed

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