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To study the efficacy and safety of oxalidine in the perioperative pain management of ERCP in children

To study the efficacy and safety of oxalidine in the perioperative pain management of ERCP in children

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500109813
Enrollment
Unknown
Registered
2025-09-25
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

ERCP was performed in children

Interventions

The Oxalidine group:Oxalidine was administered intravenously
The Fentanyl group:Fentanyl was administered intravenously

Sponsors

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

Eligibility

Sex/Gender
All
Age
2 Years to 18 Years

Inclusion criteria

Inclusion criteria: The age ranged from 2 to 18 years old. Gender is not limited; Children with pancreaticobiliary diseases requiring endoscopic retrograde cholangiopancreatography (ERCP); American Society of Anesthesiologists (ASA) grade ?-?; Informed consent was obtained from the participants or their guardians voluntarily.

Exclusion criteria

Exclusion criteria: Age 18 years old; The patient had a history of allergy to the test drugs. ASA physical status >?; Children with a history of asthma, severe circulatory diseases, and liver and kidney dysfunction; Children with nervous system and mental diseases; Use of narcotic analgesics within 24 hours, long-term (continuous or intermittent) use of benzodiazepines or opioid analgesics; The child and her guardian declined to participate in the study.

Design outcomes

Primary

MeasureTime frame
Postoperative Pain Score;

Secondary

MeasureTime frame
Incidence of opioid-related adverse events (ORAEs);The incidence of postoperative delirium;Incidence of postoperative adverse events;

Countries

China

Contacts

Public ContactZhangfeng

Shanghai Children's Medical Center

fzhang2022@163.com+86 138 3315 1759

Outcome results

None listed

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