Safety and efficacy of Esketamine in children with restlessness during recovery from general anesthesia

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300069754

Enrollment

Unknown

Registered

2023-03-24

Start date

2023-04-01

Completion date

Unknown

Last updated

2023-05-29

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

Conditions

Emergency agitation

Interventions

LEK:Esketamine was administered nasally at 0.5mg/kg

HEK:Esketamine was administered nasally at 1.0 mg/kg

CON:Normal saline was administered nasally

Eligibility

Sex/Gender

All

Age

3 Years to 6 Years

Inclusion criteria

Inclusion criteria: 1.3 to 6 years old 2. American Society of Anesthesiologists (ASA) Grade ? or ? 3.BMI 15~20 kg/m2 4. Elective tonsil adenoidectomy is planned 5. The legal guardian agrees to participate in the study

Exclusion criteria

Exclusion criteria: 1. Upper respiratory tract infection 2. Runny nose or nasal discharge 3. Sleep apnea syndrome 4. Allergy or contraindication to the test drug 5. Severe systemic disease 6. Children who had general anesthesia within 2 weeks before medication 7. Use of narcotic analgesics within 24 hours prior to medication

Design outcomes

Primary

Measure	Time frame
PEAD;	—

Secondary

Measure	Time frame
Ramsay calm score;m-CHEOPS;Recovery time;	—

Countries

China

Contacts

Public ContactJiajia Li

The Second Affiliated Hospital and Yuying Children’s Hospital of Wenzhou Medical University

ljj1568@163.com18267727779

Outcome results

None listed

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