Oxycodone Hydrochloride Injection in the Postoperative Pain Relieving Treatment

Phase 3

Completed

• Conditions: Other Acute Postoperative Pain
• Interventions: Drug: Morphine; Drug: Oxycodone

• Registration Number: NCT01304134
• Lead Sponsor: Mundipharma (China) Pharmaceutical Co. Ltd

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Study First Submitted: 2011-02-23
• Study First Submitted QC: 2011-02-23
• Study First Posted: 2011-02-25
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-10
• Last Update Posted: 2015-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Morphine i.v.	Morphine	To determine the efficacy and safety of oxycodone i.v. patient-controlled analgesia (PCA)
Oxycodone i.v.	Oxycodone	To determine the efficacy and safety of oxycodone i.v. patient-controlled analgesia (PCA)

Primary Outcome Measures

Name	Time	Method
Measuring VAS	48 hours post operation	Measuring resting and coughing VAS, assessing the intensity of pain

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Investigational site; 🇨🇳 Beijing, Beijing, China