Clinical trial NCT01304134: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Other Acute Postoperative Pain
Lead sponsor: Mundipharma (China) Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2011-02-25
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Measuring VAS
timeFrame: 3h post-operation
measure: Measuring VAS
timeFrame: 24 hours post operation
measure: Measuring VAS
timeFrame: 48 hours post operation
Secondary outcomes:
measure: Dosage
timeFrame: Within 48h
measure: The dosage of other rescue analgesic drugs used within 48h post-operation.
timeFrame: 48hrs
measure: The invalid times and the total times of PCA application
timeFrame: 48hrs
measure: Satisfaction degree for analgesia
timeFrame: 48hrs
measure: AE occurrence and abnormal lab value
timeFrame: 48hrs
Other outcomes:
Locations:
city: Beijing
country: China
facility: Investigational site
state: Beijing
Study officials:
affiliation: Mundipharma China Ltd.
name: Mundipharma China Ltd.
role: STUDY_CHAIR
affiliation: Investigational Site Beijing, China
name: Mundipharma China Ltd.
role: PRINCIPAL_INVESTIGATOR
References: