Oxycodone Hydrochloride Injection in the Postoperative Pain Relieving Treatment

Other Acute Postoperative Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01304134
• Other study ID #: OXYI09-CN-302
• Status: Completed
• Phase: Phase 3
• First received: February 23, 2011
• Last updated: August 10, 2015
• Start date: March 2010
• Est. completion date: August 2010

Study information

• Verified date: August 2015
• Source: Mundipharma (China) Pharmaceutical Co. Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Other Acute Postoperative Pain
• Pain, Postoperative

Intervention

Drug:
• Oxycodone
dosage:10mg/l dosage form:injection frequency:via PCA pump, background rate:0.5ml/h, 2ml/time duration:48 hours
• Morphine
dosage: 10mg/ml dosage form: injection frequency: via PCA pump, background rate: 0.5ml/h, 2ml/times duration: 48 hours

Locations

Country	Name	City	State
China	Investigational site	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Mundipharma (China) Pharmaceutical Co. Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measuring VAS	Measuring resting and coughing VAS, assessing the intensity of pain	3h post-operation	No
Primary	Measuring VAS	Measuring resting and coughing VAS, assessing the intensity of pain	24 hours post operation	No
Primary	Measuring VAS	Measuring resting and coughing VAS, assessing the intensity of pain	48 hours post operation	No
Secondary	Dosage	Total dosage of study drugs within 48h.	Within 48h	No
Secondary	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	Yes
Secondary	The invalid times and the total times of PCA application	The invalid times and the total times of PCA application	48hrs	No
Secondary	Satisfaction degree for analgesia	Satisfaction degree for analgesia after the treatment	48hrs	No
Secondary	AE occurrence and abnormal lab value	AE and normal lab value will be recorded during the study	48hrs	Yes