Back to resultsOxycodone Hydrochloride Injection in the Postoperative Pain Relieving Treatment
Primary Purpose
Other Acute Postoperative Pain
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Oxycodone
Morphine
Sponsored by
About this trial
This is an interventional treatment trial for Other Acute Postoperative Pain
Eligibility Criteria
Inclusion Criteria:
- Patients of either sex aged 18 to 65 years old, with a standard body weight [standard body weight = height (cm) - 100] ±15%.
- ASA I and II.
- 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.
- Hospitalized patients on non-emergency condition who have been given appropriate preoperative treatments.
- Patients who are willing to participate in the study and have signed the written informed consent.
- Negative pregnancy test result should be obtained for women of child-bearing age.
Exclusion Criteria:
- Long-term analgesics or psychotropic drugs (including opioids, NSAIDs, sedatives, antidepressants) taken for the chronic pain, or patients abusing alcohol.
- Body weight is less than or over ±15% of the standard body weight.
- Severe impairment of liver and renal function at preoperative stage (ALT, AST, BUN, Cr).
- Medical history of recovering from abnormal surgery anesthesia.
- Medical history of hypertension (Systolic blood pressure ≥180Hg, Diastolic blood pressure 110Hg).
- Esophagus reflux disease.
- Sedatives, anti-emetics, and anti-pruritic drugs were taken 24 hours before operation.
- Have known hypersensitivity to opioids.
- Monoamine oxidase inhibitors and antidepressant drugs were taken within 15 days.
- Patients with shock.
- Patients with COPD.
- Patients can not understand the VAS or unable to use PCA.
- Pregnant or parturient women.
Sites / Locations
- Investigational site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Oxycodone i.v.
Morphine i.v.
Arm Description
To determine the efficacy and safety of oxycodone i.v. patient-controlled analgesia (PCA)
To determine the efficacy and safety of oxycodone i.v. patient-controlled analgesia (PCA)
Outcomes
Primary Outcome Measures
Measuring VAS
Measuring resting and coughing VAS, assessing the intensity of pain
Measuring VAS
Measuring resting and coughing VAS, assessing the intensity of pain
Measuring VAS
Measuring resting and coughing VAS, assessing the intensity of pain
Secondary Outcome Measures
Dosage
Total dosage of study drugs 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.
The invalid times and the total times of PCA application
The invalid times and the total times of PCA application
Satisfaction degree for analgesia
Satisfaction degree for analgesia after the treatment
AE occurrence and abnormal lab value
AE and normal lab value will be recorded during the study
Full Information
NCT ID
NCT01304134
First Posted
February 23, 2011
Last Updated
August 10, 2015
Sponsor
Mundipharma (China) Pharmaceutical Co. Ltd
1. Study Identification
Unique Protocol Identification Number
NCT01304134
Brief Title
Oxycodone Hydrochloride Injection in the Postoperative Pain Relieving Treatment
Official Title
A Prospective, Randomized, Blind, Multicentre, Parallel Group Study to Investigate the Efficacy and Safety of Oxycodone Hydrochloride Injection in the Postoperative Pain Relieving Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mundipharma (China) Pharmaceutical Co. Ltd
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Other Acute Postoperative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
240 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oxycodone i.v.
Arm Type
Experimental
Arm Description
To determine the efficacy and safety of oxycodone i.v. patient-controlled analgesia (PCA)
Arm Title
Morphine i.v.
Arm Type
Active Comparator
Arm Description
To determine the efficacy and safety of oxycodone i.v. patient-controlled analgesia (PCA)
Intervention Type
Drug
Intervention Name(s)
Oxycodone
Other Intervention Name(s)
Oxycodone Injection
Intervention Description
dosage:10mg/l dosage form:injection frequency:via PCA pump, background rate:0.5ml/h, 2ml/time duration:48 hours
Intervention Type
Drug
Intervention Name(s)
Morphine
Other Intervention Name(s)
Morphine Injection
Intervention Description
dosage: 10mg/ml dosage form: injection frequency: via PCA pump, background rate: 0.5ml/h, 2ml/times duration: 48 hours
Primary Outcome Measure Information:
Title
Measuring VAS
Description
Measuring resting and coughing VAS, assessing the intensity of pain
Time Frame
3h post-operation
Title
Measuring VAS
Description
Measuring resting and coughing VAS, assessing the intensity of pain
Time Frame
24 hours post operation
Title
Measuring VAS
Description
Measuring resting and coughing VAS, assessing the intensity of pain
Time Frame
48 hours post operation
Secondary Outcome Measure Information:
Title
Dosage
Description
Total dosage of study drugs within 48h.
Time Frame
Within 48h
Title
The dosage of other rescue analgesic drugs used within 48h post-operation.
Description
The dosage of other rescue analgesic drugs used within 48h post-operation.
Time Frame
48hrs
Title
The invalid times and the total times of PCA application
Description
The invalid times and the total times of PCA application
Time Frame
48hrs
Title
Satisfaction degree for analgesia
Description
Satisfaction degree for analgesia after the treatment
Time Frame
48hrs
Title
AE occurrence and abnormal lab value
Description
AE and normal lab value will be recorded during the study
Time Frame
48hrs
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients of either sex aged 18 to 65 years old, with a standard body weight [standard body weight = height (cm) - 100] ±15%.
ASA I and II.
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.
Hospitalized patients on non-emergency condition who have been given appropriate preoperative treatments.
Patients who are willing to participate in the study and have signed the written informed consent.
Negative pregnancy test result should be obtained for women of child-bearing age.
Exclusion Criteria:
Long-term analgesics or psychotropic drugs (including opioids, NSAIDs, sedatives, antidepressants) taken for the chronic pain, or patients abusing alcohol.
Body weight is less than or over ±15% of the standard body weight.
Severe impairment of liver and renal function at preoperative stage (ALT, AST, BUN, Cr).
Medical history of recovering from abnormal surgery anesthesia.
Medical history of hypertension (Systolic blood pressure ≥180Hg, Diastolic blood pressure 110Hg).
Esophagus reflux disease.
Sedatives, anti-emetics, and anti-pruritic drugs were taken 24 hours before operation.
Have known hypersensitivity to opioids.
Monoamine oxidase inhibitors and antidepressant drugs were taken within 15 days.
Patients with shock.
Patients with COPD.
Patients can not understand the VAS or unable to use PCA.
Pregnant or parturient women.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mundipharma China Ltd.
Organizational Affiliation
Mundipharma China Ltd.
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mundipharma China Ltd.
Organizational Affiliation
Investigational Site Beijing, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Investigational site
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100022
Country
China
12. IPD Sharing Statement
Learn more about this trial
Oxycodone Hydrochloride Injection in the Postoperative Pain Relieving Treatment
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