Skip to content

Melatonin and oral midazolam in sedation for electroencephalography of children

Comparison of efficacy of melatonin and oral midazolam in sedation for electroencephalography of children

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT201107182639N5
Enrollment
80
Registered
2011-07-24
Start date
2011-07-23
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. Episodic and paroxysmal disorders

Interventions

Intervention 1: oral melatonin 0.3 mg/kg/dose. Intervention 2: oral midazolam 0.75mg/kg/dose.
oral melatonin 0.3 mg/kg/dose
oral midazolam 0.75mg/kg/dose

Sponsors

Deputy of research -Shahid Sadoughi University of Medical Sciences , Yazd, Iran
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 10 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: age 1-18 years old; children who are referred to EEG center but don’t obey, , class 1 or 2 of ASA Exclusion criteria: Presence of gastritis or any other serious systemic diseases, use of sedative in two days ago ; occurrence of severe systemic reaction wth drugs

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Sedation induction with achieving of a level of four on the Ramsay scale. Timepoint: every 15 minutes. Method of measurement: clinical.;Success in recording of EEG. Timepoint: one hour after drug use. Method of measurement: clinical.

Secondary

MeasureTime frame
Serious adverse events (hypotension, hypoxia and cyanosis, severe vomiting, irritability, apnea, laryngospasm, and bradycardia). Timepoint: every 10 minutes. Method of measurement: clinical.;Side effects. Timepoint: every 15 minutes. Method of measurement: clinical.;Time to induction of sedation. Timepoint: every 15 minutes. Method of measurement: clinical.;Caregiver’s satisfaction scale. Timepoint: after 2 hours of drug use. Method of measurement: asking from caregiver.;Total stay time in EEG unit. Timepoint: every 30 minutes. Method of measurement: asking from parents.

Countries

Iran (Islamic Republic of)

Outcome results

None listed

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