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The comparison study of midazolam and promethazine premedication in MRI outpatients

The comparison study of midazolam and promethazine premedication in MRI outpatients undergone general anesthesia in children, imaging ward of children's medical center 2020

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200521047530N2
Enrollment
116
Registered
2020-09-29
Start date
2020-10-22
Completion date
Unknown
Last updated
2020-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

patients candidate for MRI.

Interventions

Intervention 1: Intervention group: Promethazine/ Half an hour before separation, 1 mg / kg promethazine (with 20 cc of sugar water) will be given. Intervention 2: Control group: midazolam/ Half an ho

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 10 Years

Inclusion criteria

Inclusion criteria: All patients aged 1 to 10 years old ASA class 1 and 2 Patients who have referred to the Pediatric Medical Center Hospital for outpatient MRI under anesthesia.

Exclusion criteria

Exclusion criteria: Dissatisfaction of parents to participate in the project Genetic and congenital diseases History of allergy to the studied drugs behavioral disorders Use of psychiatric drugs and any mental disorders in the child Use sleeping pills before visiting Patients with ASA grade 3 and above Non-Persian speaking family

Design outcomes

Primary

MeasureTime frame
Sedation criteria. Timepoint: Measure immediately after entering recovery. Method of measurement: RAMSAY criteria score.;Delirium emergence score. Timepoint: Measure immediately after entering recovery. Method of measurement: PAED score.

Secondary

MeasureTime frame
Recovery time. Timepoint: After entering the recovery. Method of measurement: Interval from admission to recovery ward until discharge.;Sedation score. Timepoint: After entering the recovery. Method of measurement: Ramsay Score.;Delirium emergence score. Timepoint: After entering the recovery. Method of measurement: PAED score.;Nurses' satisfaction. Timepoint: After entering the recovery. Method of measurement: RN satisfaction score.;Nausea and vomiting. Timepoint: After entering the recovery. Method of measurement: View.;Bronchospasm and laryngospasm. Timepoint: After entering the recovery. Method of measurement: Observation of symptoms and auscultation.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNima Nazari

Tehran University of Medical Sciences

nima.nazari1366@gmail.com00982161479

Outcome results

None listed

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