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oral chloral hydrate and intranasal midazolam in sedation induction for CT scan

Comparison of efficacy of oral chloral hydrate and intranasal midazolam in sedation for CT scan in children

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT201107082639N4
Enrollment
60
Registered
2011-07-21
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

other disorders of the nervous system. Other disorders of the nervous system

Interventions

Intervention 1: Chloral hydrate, 70 mg/kg single dose, orally. Intervention 2: intranasal midazolam, 0.2mg/kg single dose.
Treatment - Drugs
intranasal midazolam, 0.2mg/kg single dose

Sponsors

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

Eligibility

Sex/Gender
All
Age
1 Years to 18 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria:age 1-18 years old; children who are referred to CT scan center but don’t obey; class 1 or 2 of ASA Exclusion criteria: use of chloral hydrate or midazolam in recently 48 hours ; gastritis or any other serious systemic diseases ; history of drugs allergy ; occurrence of severe systemic drugs reaction

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Sedation until Ramsay score of four be attained. Timepoint: every 15 minutes. Method of measurement: clinical.;Efficacy of drugs in sedation induction. Timepoint: every 15 minutes. Method of measurement: clinical exam.

Secondary

MeasureTime frame
Side effects. Timepoint: every 15 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.;Vital signs(blood pressure , pulse rate , respiratory rate. Timepoint: every 15 minutes. Method of measurement: clinical exam.;Time to induction of sedation,. Timepoint: eyery 30 minutes. Method of measurement: clinical exam.;Total stay time in CT scan unit. Timepoint: after 2 hours of drug use. Method of measurement: asking from parents.;Caregiver’s satisfaction. Timepoint: after 2 hours 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