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chloral hydrate -hydroxyzine and chloral hydrate – oral midazolam in sedation induction for MRI in children

Comparison of efficacy of chloral hydrate -hydroxyzine and chloral hydrate – oral midazolam in sedation induction for MRI in children

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT201302092639N10
Enrollment
60
Registered
2013-02-23
Start date
2012-11-30
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

CNS diseases. Other disorders of the nervous system

Interventions

Intervention 1: combination of 40 mg/kg of chloral hydrate and 1mg/kg hydroxyzine. Intervention 2: 40 mg/kg of chloral hydrate and 0.5mg/kg oral midazolam.
combination of 40 mg/kg of chloral hydrate and 1mg/kg hydroxyzine
40 mg/kg of chloral hydrate and 0.5mg/kg oral midazolam

Sponsors

Deputy of Research of Shahid Sadoughi University of Medical Sciences,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 MRI Unit but don’t obey, 2. Age 1-7 years old 3. Class 1 or 2 of ASA 4. Do not receive a sedative hypnotic agent within the past 48 hours 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
Adequate sedation (Ramsay score of four is attained). Timepoint: every 15 minutes. Method of measurement: clinical exam.;Success in taking of MRI. Timepoint: every 15 minutes. Method of measurement: clinical exam.

Secondary

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

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr.Razieh Fallah

Shahid Sadoughi University of Medical Sciences , Yazd , Iran

FALLAH@ssu.ac.ir+98 35 1822 4000

Outcome results

None listed

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