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ED 50 of esketamine intranasally used for sedation in children with MRI examination when combined with midazolam orally: A prospective dose-finding study using up-and-down sequential allocation method

ED 50 of esketamine intranasally used for sedation in children with MRI examination when combined with midazolam orally: A prospective dose-finding study using up-and-down sequential allocation method

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400087873
Enrollment
Unknown
Registered
2024-08-06
Start date
2024-08-06
Completion date
Unknown
Last updated
2024-08-12

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

Conditions

Pediatric sedation

Interventions

Test group:Subsequently, the child is administered 0.5 mg/kg of midazolam orally. After a waiting period of 5 minutes, a modified sequential method is employed to administer 1 mg/kg of esketamine intr

Sponsors

Sanya Women And Children's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
0.5 Years to 6 Years

Inclusion criteria

Inclusion criteria: Age from 6 months to 6 years old; ASA grade I-II; no mental disorders; no congenital systemic diseases; normal liver and kidney function

Exclusion criteria

Exclusion criteria: Children who are allergic to the medications used in this study;Children with severe liver and kidney dysfunction, children with infectious disease, children with asthma, and children with mental disorders Children who were using or had recently used (< 24 h) a sedative.) The child's guardian was consulted and informed consent was signed for the conduct of the study

Design outcomes

Primary

MeasureTime frame
Sedative effect;Whether the sedation was successful or not;

Secondary

MeasureTime frame
Pulse oxygen saturation;blood pressure;heart rate;Respiratory rate;The number of adverse events that occurred; Aldrete score;

Countries

China

Contacts

Public ContactYujuan Tao

Sanya Women And Children's Hospital

sysfybjymzk@163.com+86 133 3756 6090

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 6, 2026