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Melatonin and oral midazolam in sedation for electroencephalography of childre

Not Applicable
Conditions
Epilepsy.
Episodic and paroxysmal disorders
G40- G47
Registration Number
IRCT201107182639N5
Lead Sponsor
Deputy of research -Shahid Sadoughi University of Medical Sciences , Yazd, Iran
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
80
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

Not provided

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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 Outcome Measures
NameTimeMethod
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.
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