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Midazolam oral solution for preoperative sedation in children with left-to-right shunt congenital heart disease in ED90

Midazolam oral solution for preoperative sedation in children with left-to-right shunt congenital heart disease in ED90

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500111281
Enrollment
Unknown
Registered
2025-10-29
Start date
2025-11-05
Completion date
Unknown
Last updated
2025-11-03

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

Conditions

Atrial septal defect, ventricular septal defect, and patent ductus arteriosus.

Interventions

infant group (6 months to 1 year):Midazolam Oral Solution Sedation
preschool group (3 to 6 years):Midazolam Oral Solution Sedation
toddler group (1 to 3 years):Midazolam Oral Solution Sedation

Sponsors

Children's Hospital of Chongqing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 6 Years

Inclusion criteria

Inclusion criteria: 1.Left-to-right shunt type congenital heart disease; 2.Age 6 months to 6 years; 3.ASA grade ?-?;

Exclusion criteria

Exclusion criteria: 1. Refusal to participate by the child's guardian; 2. Allergy to midazolam; 3. Acute closed-angle glaucoma or open-angle glaucoma without effective treatment; 4. Abnormalities in the child's liver and kidney function; 5. Abnormalities in the child's heart function; 6. Preoperative use of other sedative drugs;

Design outcomes

Primary

MeasureTime frame
Calming effect;Calming effect;

Secondary

MeasureTime frame
Respiratory rate;heart rate;Non-invasive blood pressure;Oxygen saturation;

Countries

China

Contacts

Public ContactLifei Liu

Children's Hospital of Chongqing Medical University

54099645@qq.com+86 23 6363 2143

Outcome results

None listed

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