Oxycodone Hydrochloride Injection in the Postoperative Pain Relieving Treatment
Information source: Mundipharma (China) Pharmaceutical Co. Ltd
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Other Acute Postoperative Pain
Intervention: Oxycodone (Drug); Morphine (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Mundipharma (China) Pharmaceutical Co. Ltd Official(s) and/or principal investigator(s): Mundipharma China Ltd., Study Chair, Affiliation: Mundipharma China Ltd. Mundipharma China Ltd., Principal Investigator, Affiliation: Investigational Site Beijing, China
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Primary outcome: Measuring VASMeasuring VAS Measuring VAS
Secondary outcome: DosageThe dosage of other rescue analgesic drugs used within 48h post-operation. The invalid times and the total times of PCA application Satisfaction degree for analgesia AE occurrence and abnormal lab value
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Investigational site, Beijing, Beijing 100022, China
Additional Information
Starting date: March 2010
Last updated: August 10, 2015
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