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Oxycodone Hydrochloride Injection in the Postoperative Pain Relieving Treatment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mundipharma
ClinicalTrials.gov Identifier:
NCT01304134
First received: February 23, 2011
Last updated: August 27, 2012
Last verified: June 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Other Acute Postoperative Pain
 Drug: Oxycodone
Drug: Morphine
 Phase 3

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mundipharma:

Primary Outcome Measures:
  • Measuring VAS from 3h post-operation. [ Time Frame: 3h post-operation ] [ Designated as safety issue: No ]
    Measuring resting and coughing VAS at 3h, 24h, 48h post-operation, assessing the intensity of pain.


Secondary Outcome Measures:
  • Dosage [ Time Frame: Within 48h ] [ Designated as safety issue: No ]
    Total dosage of study drugs within 48h.

  • The dosage of other rescue analgesic drugs used within 48h post-operation. [ Time Frame: 48hrs ] [ Designated as safety issue: Yes ]
    The dosage of other rescue analgesic drugs used within 48h post-operation.

  • The invalid times and the total times of PCA application [ Time Frame: 48hrs ] [ Designated as safety issue: No ]
    The invalid times and the total times of PCA application

  • Satisfaction degree for analgesia [ Time Frame: 48hrs ] [ Designated as safety issue: No ]
    Satisfaction degree for analgesia after the treatment

  • AE occurrence and abnormal lab value [ Time Frame: 48hrs ] [ Designated as safety issue: Yes ]
    AE and normal lab value will be recorded during the study


Enrollment: 240
Study Start Date: March 2010
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oxycodone i.v.
To determine the efficacy and safety of oxycodone i.v. patient-controlled analgesia (PCA)
 Drug: Oxycodone
dosage:10mg/l dosage form:injection frequency:via PCA pump, background rate:0.5ml/h, 2ml/time duration:48 hours
Other Name: Oxycodone Injection
Active Comparator: Morphine i.v.
To determine the efficacy and safety of oxycodone i.v. patient-controlled analgesia (PCA)
 Drug: Morphine
dosage: 10mg/ml dosage form: injection frequency: via PCA pump, background rate: 0.5ml/h, 2ml/times duration: 48 hours
Other Name: Morphine Injection

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01304134

Locations
China, Beijing
Investigational site
Beijing, Beijing, China, 100022
Sponsors and Collaborators
Mundipharma
Investigators
Study Chair: Mundipharma China Ltd. Mundipharma China Ltd.
Principal Investigator: Mundipharma China Ltd. Investigational Site Beijing, China
  More Information

No publications provided

Responsible Party: Mundipharma
ClinicalTrials.gov Identifier: NCT01304134     History of Changes
Other Study ID Numbers: OXYI09-CN-302
Study First Received: February 23, 2011
Last Updated: August 27, 2012
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Morphine
Oxycodone
Analgesics, Opioid
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotics

ClinicalTrials.gov processed this record on May 22, 2013