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Oxycodone Injection for Postoperative Pain
NCT01304134Phase 3
Key facts
- Status
- Completed
- Start
- Mar 2010
- Primary completion
- Aug 2010
- Countries
- 1
- Sponsor
- Mundipharma
- Modality
- Small Molecules
- Drugs
- oxycodone
- Conditions
- postoperative pain
01
Overview
Phase 3, randomised, double-blind trial of oxycodone in postoperative pain (2 arms), sponsored by Mundipharma. Primary endpoint: Visual Analog Scale at 48 hours. Started Mar 2010; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Oxycodone i.v.
Oxycodone i.v. PCA (10mg/l, background 0.5ml/h, 2ml/time)
Morphine i.v.
Morphine i.v. PCA (10mg/ml, background 0.5ml/h, 2ml/time)
03
Who it enrols
Patients aged 18-65 undergoing elective open upper abdominal surgery (liver, gall bladder, spleen, stomach, kidney, colon) with ASA I-II. Excludes patients with severe liver/renal impairment, hypertension, COPD, shock, or history of substance abuse.
04
Endpoints
Primary
Visual Analog Scale
Secondary
Total Drug Dosage
Rescue Analgesic Dosage
PCA Application Times
Satisfaction Degree for Analgesia
Adverse Event Occurrence
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