Oral Oxycodon 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 emcompasses 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.
Heart; Dysfunction Postoperative, Cardiac Surgery
|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|
- 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
- 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 ]
|Study Start Date:||July 2011|
|Study Completion Date:||March 2013|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
Active Comparator: Targin/OxyNorm
Patients randomized to this study arm will receive Targin as basis pain medication and additional OxyNorm (Oxycodon), if requested by the patients.
Other Name: Oxycodonhydrochlorid and naloxone hydrochloride dihydrateDrug: 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.