Oxycodone Hydrochloride Injection in the Postoperative Pain Relieving Treatment

A Prospective, Randomized, Blind, Multicentre, Parallel Group Study to Investigate the Efficacy and Safety of Oxycodone Hydrochloride Injection in the Postoperative Pain Relieving Treatment

To determine the efficacy and safety of oxycodone i.v. patient-controlled analgesia (PCA) in the pain relieving treatment during 48h postoperative period, by comparing with morphine i.v. PCA.

Study Overview

• Status: Completed
• Conditions: Other Acute Postoperative Pain
• Intervention / Treatment: Drug: Oxycodone; Drug: Morphine

• Study Type: Interventional
• Enrollment (Actual): 240
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100022
      • Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients of either sex aged 18 to 65 years old, with a standard body weight [standard body weight = height (cm) - 100] ±15%.
2. ASA I and II.
3. Scheduled on elective open upper abdominal surgery under general anesthesia (liver, gall bladder, spleen, stomach, kidney, colon surgery), of which predicted operation duration is between 2-4h.
4. Hospitalized patients on non-emergency condition who have been given appropriate preoperative treatments.
5. Patients who are willing to participate in the study and have signed the written informed consent.
6. Negative pregnancy test result should be obtained for women of child-bearing age.

Exclusion Criteria:

1. Long-term analgesics or psychotropic drugs (including opioids, NSAIDs, sedatives, antidepressants) taken for the chronic pain, or patients abusing alcohol.
2. Body weight is less than or over ±15% of the standard body weight.
3. Severe impairment of liver and renal function at preoperative stage (ALT, AST, BUN, Cr).
4. Medical history of recovering from abnormal surgery anesthesia.
5. Medical history of hypertension (Systolic blood pressure ≥180Hg, Diastolic blood pressure 110Hg).
6. Esophagus reflux disease.
7. Sedatives, anti-emetics, and anti-pruritic drugs were taken 24 hours before operation.
8. Have known hypersensitivity to opioids.
9. Monoamine oxidase inhibitors and antidepressant drugs were taken within 15 days.
10. Patients with shock.
11. Patients with COPD.
12. Patients can not understand the VAS or unable to use PCA.
13. Pregnant or parturient women.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oxycodone i.v.; To determine the efficacy and safety of oxycodone i.v. patient-controlled analgesia (PCA)	Drug: Oxycodone; dosage:10mg/l dosage form:injection frequency:via PCA pump, background rate:0.5ml/h, 2ml/time duration:48 hours; Other Names: Oxycodone Injection
Active Comparator: Morphine i.v.; To determine the efficacy and safety of oxycodone i.v. patient-controlled analgesia (PCA)	Drug: Morphine; dosage: 10mg/ml dosage form: injection frequency: via PCA pump, background rate: 0.5ml/h, 2ml/times duration: 48 hours; Other Names: Morphine Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measuring VAS	Measuring resting and coughing VAS, assessing the intensity of pain	3h post-operation
Measuring VAS	Measuring resting and coughing VAS, assessing the intensity of pain	24 hours post operation
Measuring VAS	Measuring resting and coughing VAS, assessing the intensity of pain	48 hours post operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dosage	Total dosage of study drugs within 48h.	Within 48h
The dosage of other rescue analgesic drugs used within 48h post-operation.	The dosage of other rescue analgesic drugs used within 48h post-operation.	48hrs
The invalid times and the total times of PCA application	The invalid times and the total times of PCA application	48hrs
Satisfaction degree for analgesia	Satisfaction degree for analgesia after the treatment	48hrs
AE occurrence and abnormal lab value	AE and normal lab value will be recorded during the study	48hrs

Collaborators and Investigators

• Sponsor: Mundipharma (China) Pharmaceutical Co. Ltd
• Investigators: Principal Investigator: Mundipharma China Ltd., Investigational Site Beijing, China

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): August 1, 2010
• Study Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: February 23, 2011
• First Submitted That Met QC Criteria: February 23, 2011
• First Posted (Estimate): February 25, 2011

Study Record Updates

• Last Update Posted (Estimate): August 11, 2015
• Last Update Submitted That Met QC Criteria: August 10, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Morphine; Oxycodone
• Other Study ID Numbers: OXYI09-CN-302