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Completed

NCT Number: NCT01304134

Oxycodone Hydrochloride Injection in the Postoperative Pain Relieving Treatment

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Investigational site

Beijing, Beijing Municipality, 100022, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients of either sex aged 18 to 65 years old, with a standard body weight [standard body weight = height (cm) - 100] ±15%.
  • ASA I and II.
  • 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.
  • Hospitalized patients on non-emergency condition who have been given appropriate preoperative treatments.
  • Patients who are willing to participate in the study and have signed the written informed consent.
  • Negative pregnancy test result should be obtained for women of child-bearing age.

Exclusion criteria

  • Long-term analgesics or psychotropic drugs (including opioids, NSAIDs, sedatives, antidepressants) taken for the chronic pain, or patients abusing alcohol.
  • Body weight is less than or over ±15% of the standard body weight.
  • Severe impairment of liver and renal function at preoperative stage (ALT, AST, BUN, Cr).
  • Medical history of recovering from abnormal surgery anesthesia.
  • Medical history of hypertension (Systolic blood pressure ≥180Hg, Diastolic blood pressure 110Hg).
  • Esophagus reflux disease.
  • Sedatives, anti-emetics, and anti-pruritic drugs were taken 24 hours before operation.
  • Have known hypersensitivity to opioids.
  • Monoamine oxidase inhibitors and antidepressant drugs were taken within 15 days.
  • Patients with shock.
  • Patients with COPD.
  • Patients can not understand the VAS or unable to use PCA.
  • Pregnant or parturient women.

Treatment and study plan

Oxycodone

Drug

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

Other names: Oxycodone Injection

Morphine

Drug

dosage: 10mg/ml dosage form: injection frequency: via PCA pump, background rate: 0.5ml/h, 2ml/times duration: 48 hours

Other names: Morphine Injection

Primary outcomes

  1. Measuring VAS

    Time frame: 3h post-operation

    Measuring resting and coughing VAS, assessing the intensity of pain

  2. Measuring VAS

    Time frame: 24 hours post operation

    Measuring resting and coughing VAS, assessing the intensity of pain

  3. Measuring VAS

    Time frame: 48 hours post operation

    Measuring resting and coughing VAS, assessing the intensity of pain

Secondary outcomes

  1. Dosage

    Time frame: Within 48h

    Total dosage of study drugs within 48h.

  2. The dosage of other rescue analgesic drugs used within 48h post-operation.

    Time frame: 48hrs

    The dosage of other rescue analgesic drugs used within 48h post-operation.

  3. The invalid times and the total times of PCA application

    Time frame: 48hrs

    The invalid times and the total times of PCA application

  4. Satisfaction degree for analgesia

    Time frame: 48hrs

    Satisfaction degree for analgesia after the treatment

  5. AE occurrence and abnormal lab value

    Time frame: 48hrs

    AE and normal lab value will be recorded during the study

Sponsors and collaborators

Lead sponsor

Mundipharma (China) Pharmaceutical Co. Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Feb 25, 2011
Registry last updated
Aug 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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