Opioid Related Disorders, Postoperative Pain
Conditions
Keywords
Naloxone, Oxycodone, Constipation, Pain, postoperative, Physiological effects of drugs, Analgesics, Opioid
Brief summary
The aim of the study is to describe the effects of oxycodone/naloxone combination in comparison to oxycodone for the treatment of postoperative pain in patients undergoing cardiac surgery. The hypothesis is that the duration of opioid-induced bowel dysfunction and the need of laxatives will decrease.
Detailed description
Opioid-induced bowel dysfunction is common in cardiac surgery patients postoperatively. Opioids are needed to treat severe postoperative pain, but they have troublesome side-effects such as nausea, vomiting and bowel dysfunction. These symptoms also limit the use of gastrointestinal tract for nutrition and medication. Combined prolonged-releases oxycodone and naloxone has been shown to provide as effective analgesia as PR oxycodone. Oxycodone/naloxone has also been suggested to improve bowel function without compromising analgesic efficacy. The aim of the study is to describe the effects of oxycodone/naloxone combination in comparison to oxycodone for the treatment of postoperative pain in patients undergoing cardiac surgery. During the first three months of the study, all cardiac surgery patients will be treated with PR oxycodone. During the second part of the study (3 months), all cardiac surgery patients will be treated with PR oxycodone/naloxone. The primary end point is the duration of opioid-induced bowel dysfunction. Need of laxatives will be recorded.
Interventions
DRUGOxycodone
Prolonged-release oxycodone 10-30 mg twice daily
DRUGProlonged-release oxycodone/naloxone
Prolonged-release oxycodone/naloxone 10-30 mg twice daily
Sponsors
Kati Järvelä
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult cardiac surgery patient
Exclusion criteria
* Preoperative continuous use of laxatives * Known anatomic or functional gastrointestinal disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of opioid-induced bowel dysfunction postoperatively | Participants will be followed for the duration of hospital stay, an expected average of 5 days |
Secondary
| Measure | Time frame |
|---|---|
| Need of laxatives postoperatively | Participants will be followed for the duration of hospital stay, an expected average of 5 days |
Countries
Finland
Outcome results
None listed