Analysis of PCIA effect of esketamine combined with sufentanil after lower limb orthopedic surgery in children

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300078468

Enrollment

Unknown

Registered

2023-12-08

Start date

2023-06-19

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

Postoperative analgesia in children

Interventions

Sufentanil alone group (S group):Sufentanil alone

Esketamine combined with sufentanil group (ES group) :Esketamine combined with sufentanil

Eligibility

Sex/Gender

All

Age

6 Years to 14 Years

Inclusion criteria

Inclusion criteria: ? Unilateral lower limb correction surgery due to talipes equinovarus; ? Age 6-14 years old; ? BMI 18-24kg/m2; ? ASA grading I/II; ? No abnormalities were found in important organs such as the heart and lungs, as well as coagulation function.

Exclusion criteria

Exclusion criteria: ? Having uncontrolled underlying diseases; ? Simultaneously perform bilateral talipes equinovarus surgery; ? Allergy to the drug in this study; ? Delayed development, intellectual disability, inability to communicate normally with medical staff; ? Abnormal liver and kidney function; ? Have taken mental grade analgesics within the past month; ? Having a history of contraindications to esketamine, such as hyperthyroidism, epilepsy, etc.; ? Have a history of respiratory tract infection in the past 2 weeks.

Design outcomes

Primary

Measure	Time frame
Wong Banker Facial Expression Scale (FPS-R);	—

Secondary

Measure	Time frame
Ramsay Sedation Scale;	—

Countries

China

Contacts

Public ContactYang Renmeng

Shandong Rehabilitation Research Center (Shandong Rehabilitation Hospital)

88692169@163.com+86 186 6898 7913

Outcome results

None listed

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