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The comparison of nalbuphine and fentanyl on paIn management for percutaneous endoscopic debridement in patients with infected necrotizing pancreatitis: an open-label, observational study

The comparison of nalbuphine and fentanyl on paIn management for percutaneous endoscopic debridement in patients with infected necrotizing pancreatitis: an open-label, observational study

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000033302
Enrollment
Unknown
Registered
2020-05-27
Start date
2020-06-01
Completion date
Unknown
Last updated
2020-06-01

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

Conditions

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Interventions

Nalbuphine Group :Intravenous nalbuphine
Fentanyl Group :Intravenous fentanyl

Sponsors

Chinese people's Liberation Army General Hospital of Eastern Theater Command
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-70 years old and American Society of Anesthesiologists Physical Status Classification (ASA grade) <= II; 2. Diagnosed as infected necrotizing pancreatitis; 3. Patients stay awake and cooperate well without mechanical ventilation; 4. Patients receive PED without contraindication; 5. Informed consents were obtained from enrolled patients.

Exclusion criteria

Exclusion criteria: 1. Death is deemed imminent and inevitable; 2. Pregnancy (confirmed or suspected); 3. Patients are allergy to opioids; 4. A percutaneous measurement of oxygen saturation (SpO2) by pulse oximetry of <= 90% when delivering oxygen through a nasal cannula at 5L/min; 5. Patients with severe cardiovascular, renal or hepatic disease defined as (1) NYHA functional class III-IV, (2) ALT and/or AST level more than 1.5 times the upper limit of normal value or (3) creatinine level exceeds the upper limit of normal value.

Design outcomes

Primary

MeasureTime frame
qualified rate of analgesia;

Secondary

MeasureTime frame
Heart rate;Respiratory rate;oxygen saturation;diastolic pressure;systolic pressure;Heart rate variability;incidence of operation interruption;incidence of adverse events;Total does of analgesic;

Countries

China

Contacts

Public ContactLu Ke

Jinling Hospital affiliated to Nanjing University

ctgkelu@nju.edu.cn+86 15850768312

Outcome results

None listed

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