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Comparison of the efficacy of oral and intranasal midazolam premedication on sedation before undergoing MRI in children

Comparison of the efficacy of oral and intranasal midazolam premedication on sedation before undergoing MRI in children

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20151221025641N8
Enrollment
90
Registered
2024-05-26
Start date
2024-06-04
Completion date
Unknown
Last updated
2024-06-24

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

Conditions

Preanesthetic sedation. Sedative, hypnotic, or anxiolytic related disorders

Interventions

Intervention 1: Intervention group: 0.5 mg/kg syrup Midazolam PO, 20 minutes prior parental separation to conducting anesthesia. Intervention 2: Intervention group: 0.2 mg/kg nasal spray Midazolam int

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Months to 6 Years

Inclusion criteria

Inclusion criteria: The patient is classified as ASA class 1 to 2 according to the American Society of Anesthesiologists; The patient's age is between 6 months to 6 years; The patient is a candidate for MRI under anesthesia;

Exclusion criteria

Exclusion criteria: The patient has upper gastrointestinal tract problems; The patient has an active infection; The patient has structural disorders of the upper respiratory system; The patient is cyanotic; Having a history of drug allergy to benzodiazepines; Severe crying and restlessness of the child immediately before administering the medicine;

Design outcomes

Primary

MeasureTime frame
Sedation scale. Timepoint: 0, 5, 10, 15 and 20 minutes after receiving the intervention. Method of measurement: Scoring system and clinical assessment.

Secondary

MeasureTime frame
Parental separation anxiety scale. Timepoint: 20 minutes after receiving the intervention. Method of measurement: Scoring system and clinical assessment.;Mask acceptance score. Timepoint: 20 minutes after receiving the intervention. Method of measurement: Scoring system and clinical assessment.;Recovery score. Timepoint: Recovery time. Method of measurement: Scoring system and clinical assessment.;Agitation score. Timepoint: At discharge. Method of measurement: Scoring system and clinical assessment.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAshkan Taghizadeh

Tehran University of Medical Sciences

cmcpr@tums.ac.ir+98 21 6147 9000

Outcome results

None listed

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