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NALDEBAIN vs Fentanyl PCA for Post-Laparotomy Pain
NCT03296488Phase 4
Key facts
- Status
- Unknown
- Start
- Aug 2017
- Primary completion
- Dec 2018
- Countries
- 1
- Sponsor
- Kaohsiung Medical University Chung-Ho Memorial Hospital
- Modality
- Small Molecules
- Conditions
- postoperative pain
01
Overview
Phase 4, randomised, open-label trial of dinalbuphine sebacate in postoperative pain (2 arms), sponsored by Kaohsiung Medical University Chung-Ho Memorial Hospital. Primary endpoint: Pain assessment (VAS) at 48 hours. Status: unknown.
02
Design
2 arms- Study design
- RandomizedOpen-label
Nalbuphine Sebacate
Single dose of Naldebain (150 mg) IM 24±12 hours before surgery.
Fentanyl Citrate
IV PCA with Fentanyl for 48 hours after surgery.
03
Who it enrols
Adult patients (20-80 years) scheduled for elective open-laparotomy with ASA class 1-3. Excludes patients with BMI <18 or >30, chronic opioid consumption, pregnancy, or inability to use PCA.
04
Endpoints
Primary
Pain assessment (VAS)
Secondary
Supplemental analgesics
Pain assessment (post-OP to Day 6)
Brief Pain Inventory (BPI)
Patient satisfaction
Length of postoperative hospital stay
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