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

March 15, 2013
March 25, 2014
July 2011
May 2012   (final data collection date for primary outcome measure)
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
total opioid dosage in terms of so-called morphine equivalents [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]
total administrated opiod dosage during 3 days after surgery
Complete list of historical versions of study NCT01816581 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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
  • in hospital stay [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • ICU stay [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Oral Oxycodone After Major Cardiac Surgery
Prospective, Randomized Clinical Pilot Study: Oral Opiate Targin In Treatment Of Postoperative Pain After Major Cardiac Surgery

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Heart; Dysfunction Postoperative, Cardiac Surgery
  • Drug: Targin
    Other Name: Oxycodonhydrochlorid and naloxone hydrochloride dihydrate
  • Drug: Oxynorm
    Other Name: oral medication consisting of Oxycodonhydrochlorid
  • Drug: Morphine
  • 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.
    Interventions:
    • Drug: Targin
    • Drug: Oxynorm
  • 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.
    Intervention: Drug: Morphine
Ruetzler K, Blome CJ, Nabecker S, Makarova N, Fischer H, Rinoesl H, Goliasch G, Sessler DI, Koinig H. A randomised trial of oral versus intravenous opioids for treatment of pain after cardiac surgery. J Anesth. 2014 Aug;28(4):580-6. doi: 10.1007/s00540-013-1770-x. Epub 2013 Dec 28.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
March 2013
May 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT01816581
1043/2010
No
Kurt Rutzler, Medical University of Vienna
Medical University of Vienna
Not Provided
Not Provided
Medical University of Vienna
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP