Determination of the 90% effective dose of oral midazolam with intranasal eskatamine 0.25mg/kg for premedication in children: a biased-coin up-and-down sequential allocation trial

Determination of the 95% effective dose of oral midazolam with intranasal eskatamine 0.25mg/kg for preoperative sedation in children: a biased-coin up-and-down sequential allocation trial

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100044635

Enrollment

Unknown

Registered

2021-03-25

Start date

2021-04-01

Completion date

Unknown

Last updated

2021-10-26

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

Conditions

preoperative sedation for children undergoing surgery

Interventions

midazolam with eskatamine 0.25mg/kg:Finding the optimal dose range for midazolam

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Children 1-6 years old, ASA I-II, undergoing elective general surgery, urology or orthopedic surgery.

Exclusion criteria

Exclusion criteria: Children weighing more than 30 kg, with recent upper respiratory tract infections or obvious rhinitis and runny nose, psychological disorders, severe central system diseases, increased intracranial pressure, or combined with other serious cardiopulmonary diseases, preoperative use of other sedatives, allergy to midazolam or esketamine and parental refusal to use preoperative medication.

Design outcomes

Primary

Measure	Time frame
midazolam doses;	—

Secondary

Measure	Time frame
Sedation level score;Separation reaction;Face mask acceptance;Acceptance to IV cannulation;	—

Countries

China

Contacts

Public ContactYue Huang

Shanghai Children's Medical Center Affiliated to School of Medicine, Shanghai Jiao Tong University

doctorscmc@126.com+86 13916557269

Outcome results

None listed

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