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Efficacy and safety of oxycodone for postoperative controlled intravenous analgesia in children undergoing laparoscopic surgery

Efficacy and safety of oxycodone for postoperative controlled intravenous analgesia in children undergoing laparoscopic surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500109884
Enrollment
Unknown
Registered
2025-09-26
Start date
2025-10-01
Completion date
Unknown
Last updated
2025-09-29

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

Conditions

Laparoscopic surgery, Children

Interventions

Oxycodone group:Postoperative analgesic formula: oxycodone 50mg ? normal saline 100ml, loading dose 0.1mg/kg, bolus dose 0.05mg/kg, locked interval 15min (no background dose)
Sufentanil group:Postoperative analgesia formula: sufentanil 50ug ? normal saline 100ml, loading dose 0.1µg/kg, bolus dose 0.05µg/kg, locked interval 15min (no background dose).

Sponsors

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

Eligibility

Sex/Gender
All
Age
6 Years to 12 Years

Inclusion criteria

Inclusion criteria: The age ranged from 6 to 12 years. American Society of Anesthesiologists (ASA) grade ?-?; Children undergoing laparoscopic major abdominal surgery (operation duration >2 hours) under general anesthesia; BMI 18-24 kg/m^2. Informed consent was obtained from the children's guardians.

Exclusion criteria

Exclusion criteria: Age 12 years old; The patient had a history of allergy to the test drugs. Severe systemic diseases, such as severe liver and kidney dysfunction; Recent history of analgesic use, drug abuse, or chronic pain; Impaired language communication; The child and his guardian declined to participate in the study.

Design outcomes

Primary

MeasureTime frame
The FLACC score at 24h after operation was recorded;

Secondary

MeasureTime frame
Postoperative FLACC score;Otal dose of PCIA administered 48h after surgery;Effective number of compressions;Rescue analgesia;Satisfaction of family members;Postoperative adverse reactions;Length of PACU stay;

Countries

China

Contacts

Public ContactZhang Feng

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

fzhang2022@163.com+86 138 3315 1759

Outcome results

None listed

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