Comparison of effectiveness of chloral hydrate and promethazine in electroencephalography

Comparison of efficacy of oral chloral hydrate and promethazine in sedation induction for electroencephalography in children

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT138903032639N2

Enrollment

Registered

2010-05-24

Start date

2010-06-22

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: Promethazin, 1mg/kg single dose, Orally. Intervention 2: Chloral hydrate, 70 mg/kg single dose, orally.

Treatment - Drugs

Promethazin, 1mg/kg single dose, Orally

Chloral hydrate, 70 mg/kg single dose, orally

Eligibility

Sex/Gender

All

Age

1 Years to 18 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: children who are referred to EEG center but don’t obey, age 1-18 years old, class 1 or 2 of ASA Exclusion criteria: Presence of gastritis or any other serious systemic diseases, severe systemic reaction

Exclusion criteria

Exclusion criteria:

Design outcomes

Secondary

Measure	Time frame
Side effects. Timepoint: evert 15 minutes. Method of measurement: clinical exam.;Level of consciousness based on GCS number. Timepoint: every 15 minutes. Method of measurement: clinical exam.;Time to induction of sedation,. Timepoint: eyery 30 minutes. Method of measurement: clinical exam.;Vital signs(blood pressure , pulse rate , respiratory rate. Timepoint: every 10 minutes. Method of measurement: clinical exam.;Serious adverse events (hypotension, hypoxia and cyanosis, severe vomiting, irritability, apnea, laryngospasm, and bradycardia). Timepoint: every 10 minutes. Method of measurement: clinical exam.;Caregiver’s satisfaction. Timepoint: after 2 hours of drug use. Method of measurement: asking from caregiver.;Total stay time in EEG unit. Timepoint: after 2 hours of drug use. Method of measurement: asking from parents.;Efficacy of drugs in sedation induction for EEG. Timepoint: after 2 hours of drug use. Method of measurement: asking from parents.	—

Measure

Time frame

Side effects. Timepoint: evert 15 minutes. Method of measurement: clinical exam.;Level of consciousness based on GCS number. Timepoint: every 15 minutes. Method of measurement: clinical exam.;Time to induction of sedation,. Timepoint: eyery 30 minutes. Method of measurement: clinical exam.;Vital signs(blood pressure , pulse rate , respiratory rate. Timepoint: every 10 minutes. Method of measurement: clinical exam.;Serious adverse events (hypotension, hypoxia and cyanosis, severe vomiting, irritability, apnea, laryngospasm, and bradycardia). Timepoint: every 10 minutes. Method of measurement: clinical exam.;Caregiver’s satisfaction. Timepoint: after 2 hours of drug use. Method of measurement: asking from caregiver.;Total stay time in EEG unit. Timepoint: after 2 hours of drug use. Method of measurement: asking from parents.;Efficacy of drugs in sedation induction for EEG. Timepoint: after 2 hours of drug use. Method of measurement: asking from parents.

—

Primary

Measure	Time frame
Sedation until Ramsay score of four be attained. Timepoint: every 15 minutes. Method of measurement: clinical.	—

Countries

Iran (Islamic Republic of)

Outcome results

None listed

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