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Clinical study of effective dose of midazolam oral solution before operation in children

Clinical study of effective dose of midazolam oral solution before operation in children

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300078404
Enrollment
Unknown
Registered
2023-12-07
Start date
2022-06-01
Completion date
Unknown
Last updated
2023-12-10

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

Conditions

Pediatric sedation

Interventions

Infant group:The initial dose of the child is 0.25mg/kg, and the dose of the second child is determined by the sedation effect of the connected child. If the preoperative sedation effect of the former
Toddler group:The initial dose of the child is 0.25mg/kg, and the dose of the second child is determined by the sedation effect of the connected child. If the preoperative sedation effect of the forme
Preschool group:The initial dose of the child is 0.25mg/kg, and the dose of the second child is determined by the sedation effect of the connected child. If the preoperative sedation effect of the for

Sponsors

Qing Dao Women and children's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Months to 6 Years

Inclusion criteria

Inclusion criteria: Children with laparoscopic oblique hernia surgery or tonsillectomy, aged 2 months to 6 years, ASA I - II, parents (or legal guardians) of the children give informed consent and sign an informed consent form

Exclusion criteria

Exclusion criteria: ? have a history of allergy to benzodiazepines; ? have cardiovascular abnormalities and central nervous system diseases; ? have liver / kidney dysfunction or use drugs induced by chronic liver enzymes; ? have severe respiratory infection; ? have mental retardation; ? unwilling to comply with protocols or test procedures.

Design outcomes

Primary

MeasureTime frame
5-point facial hedonic scale;Ramsay scale;The onset time of sedation;The duration time of sedation;

Secondary

MeasureTime frame
Heart Rate;Blood Pressure;Pulse Oximetry;

Countries

China

Contacts

Public ContactFan Wenjie

Women and children's Hospital Affiliated to Qingdao University

qdfehospital@163.com+86 185 0532 1105

Outcome results

None listed

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