Oral Oxycodone After Major Cardiac Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kurt Rutzler, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01816581
First received: March 15, 2013
Last updated: March 25, 2014
Last verified: March 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Medical University of Vienna:

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


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

  • level of sedation [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]
    Level of Sedation using the Ramsey Sedation Score.

  • rate of spontaneous breathing [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]
    spontaneous breathing rate per minute

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

  • in hospital stay [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • ICU stay [ Time Frame: 1 month ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01816581

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

No publications provided

Responsible Party: Kurt Rutzler, senior staff physician, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01816581     History of Changes
Other Study ID Numbers: 1043/2010
Study First Received: March 15, 2013
Last Updated: March 25, 2014
Health Authority: Austria: Austrian Medicines and Medical Devices Agency

Additional relevant MeSH terms:
Morphine
Naloxone
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
Narcotic Antagonists

ClinicalTrials.gov processed this record on July 28, 2014