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Oral Oxycodone After Major Cardiac Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01816581
First Posted: March 22, 2013
Last Update Posted: March 26, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kurt Rutzler, Medical University of Vienna
  Purpose

Postoperative pain and analgesic treatment still remains a challenge in daily perioperative medicine. Skin incisions, intraoperative tissue retraction and -dissection, intravasal cannulations and drainages, sternotomy and pericardiotomy are the most important reasons for postoperative pain. Poorly controlled pain can contribute directly or indirectly to postoperative complications, such as myocardial ischemia, pulmonary dysfunction like hypoventilation, pneumonia and atelectasis, a delayed return of gastrointestinal function and decreased mobility. In addition, prolonged acute pain also results in chronic pain.

Opioids are internationally recognized as the golden standard in the treatment of acute postoperative pain. On one side, the high potency of opioids in pain relief is clearly undisputed, but on the other hand, the administration of opioids is associated with nausea, vomiting, sedation and with the development of bowel dysfunction, which encompasses symptoms including bloating, abdominal spasm, cramps and constipation. Opioid-induced constipation is a frequently reported adverse effect and sometimes requires discontinuation of therapy, which results in analgesic under-treatment, severely impairing quality of life. However, there are many different regimes for the treatment of postoperative pain using opioids. Patient-controlled analgesia (PCA) using morphine is widely used, but requires trained staff and expensive equipment. Once patients are able to tolerate oral medications, the oral route is preferred postoperatively because it is more convenient, noninvasive and less expensive.


Condition Intervention Phase
Heart; Dysfunction Postoperative, Cardiac Surgery Drug: Targin Drug: Oxynorm Drug: Morphine Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective, Randomized Clinical Pilot Study: Oral Opiate Targin In Treatment Of Postoperative Pain After Major Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by Kurt Rutzler, Medical University of Vienna:

Primary Outcome Measures:
  • total opioid dosage in terms of so-called morphine equivalents [ Time Frame: 3 days ]
    total administrated opioid dosage during 3 days after surgery


Secondary Outcome Measures:
  • VAS pain score [ Time Frame: 3 days ]
    Pain Scores on the Visual Analog Scale (0-100)

  • level of sedation [ Time Frame: 3 days ]
    Level of Sedation using the Ramsey Sedation Score.

  • rate of spontaneous breathing [ Time Frame: 3 days ]
    spontaneous breathing rate per minute

  • possible side effects [ Time Frame: 3 days ]
    open documentation of any side effects like dizziness, vomiting, allergic reaction

  • in hospital stay [ Time Frame: 1 month ]
  • ICU stay [ Time Frame: 1 month ]

Enrollment: 50
Study Start Date: July 2011
Study Completion Date: March 2013
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Targin/OxyNorm
Patients randomized to this study arm will receive Targin as basis pain medication and additional OxyNorm (Oxycodone), if requested by the patients.
Drug: Targin
Other Name: Oxycodonhydrochlorid and naloxone hydrochloride dihydrate
Drug: Oxynorm
Other Name: oral medication consisting of Oxycodonhydrochlorid
Active Comparator: PCA
Patients randomized to this group will receive a PCA pump with morphine. The basic rate is 0.3 mg/h. Patients will be allowed to administer 1 mg each five minutes after a vesting period of five minutes, if subjectively needed.
Drug: Morphine

  Eligibility

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age from 18 to 90 years
  • ASA physical status 1-3
  • Elective major cardiac surgery requiring sternotomy
  • Oral and written consent
  • Postoperative extubation within four hours after arrival at the ICU
  • Cognitive ability in the use of the PCA pump and the VAS

Exclusion Criteria:

  • Chronic use of opioids in the last three months
  • Chronic use of tranquilizer or pain medications
  • Hypersensitivity against opioids
  • Use of monoamine oxidase inhibitors in the last two weeks before surgery
  • Alcohol or drug abuse
  • Renal dysfunction (GFR < 30 or necessity of dialysis)
  • Liver Dysfunction defined as Child-Pugh-Score 7-15
  • Ejection fraction (EF< 40%)
  • Malabsorption syndrome
  • Neurologic or cognitive dysfunction
  • Pregnancy
  • Participation in another clinical trial
  • Severe respiratory depression with hypoxia and/or hypercapnia
  • Severe chronic obstructive pulmonary disease
  • Severe bronchial asthma
  • Non-opioid induced paralytic ileus
  • Risk of seizures
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01816581


Locations
Austria
Medical University Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kurt Rutzler, senior staff physician, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01816581     History of Changes
Other Study ID Numbers: 1043/2010
First Submitted: March 15, 2013
First Posted: March 22, 2013
Last Update Posted: March 26, 2014
Last Verified: March 2014

Additional relevant MeSH terms:
Morphine
Oxycodone
Naloxone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists