Oral Oxycodone After Major Cardiac Surgery
|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.|
|ClinicalTrials.gov Identifier: NCT01816581|
Recruitment Status : Completed
First Posted : March 22, 2013
Last Update Posted : March 26, 2014
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 or disease||Intervention/treatment||Phase|
|Heart; Dysfunction Postoperative, Cardiac Surgery||Drug: Targin Drug: Oxynorm Drug: Morphine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective, Randomized Clinical Pilot Study: Oral Opiate Targin In Treatment Of Postoperative Pain After Major Cardiac Surgery|
|Study Start Date :||July 2011|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||March 2013|
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.
Other Name: Oxycodonhydrochlorid and naloxone hydrochloride dihydrate
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.
- total opioid dosage in terms of so-called morphine equivalents [ Time Frame: 3 days ]total administrated opioid dosage during 3 days after surgery
- 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 ]
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
|Medical University Vienna|
|Vienna, Austria, 1090|