Postoperative Pain Clinical Trial
Official title:
A Comparison of PR Oxycodone/Naloxone and PR Oxycodone After Cardiac Surgery
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.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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