Effects of Tapentadol Versus Oxycodone After Hysterectomy.
Status:
Completed
Trial end date:
2019-02-28
Target enrollment:
Participant gender:
Summary
Opioids remain the first-line drugs for the treatment of moderate to severe postoperative
pain, but the use is limited by well-known side-effects, most of which are dose-dependent.
The opioid oxycodone is standard therapeutic treatment for acute postoperative pain, either
in immediate-release formulation, OxyNorm®, or as extended-release formulation, OxyContin®.
Oxycodone provides analgesic effects through µ-opioid receptors in the central nervous
system.
Tapentadol hydrochloride/depot (Palexia/depot®) is a novel, centrally acting, strong
analgesic with a dual mechanism of action on µ-opioid receptors and noradrenaline reuptake in
the central nervous system. Tapentadol is an active compound, devoid of active metabolites
and not reliant on enzyme systems. For these reasons, it has a low drug interaction
potential. This dual mechanism also translates clinically into less adverse effects than with
pure opioid agonists like oxycodone. This is probably due to less µ-opioid receptor
stimulation.
Tapentadol has been shown effective in models of acute, osteoarthritic, neuropathic and
cancer pain. There is now an increasing use of tapentadol in postoperative pain treatment in
Norway. However, there is a lack of broad-based evidence for the use of tapentadol in the
post-surgical setting. So far, to our knowledge, there are only published studies on
postoperative pain treatment after orthopedic and dental surgery, but none related to deep
abdominal pain.
Tapentadol is shown in several studies on chronic pain patients to have comparable analgesic
effects to traditional opioid pain medications like oxycodone and morphine, but with a more
tolerable side-effect profile. In the postoperative setting after dental or orthopedic
surgery, studies have shown less nausea and constipation. It has also been suggested a lower
frequency of pruritus compared with oxycodone, but no difference in central nervous system
symptoms such as sleepiness or dizziness. The most dangerous side-effect from opioids is
respiratory depression with the potential of fatal outcome. The investigators have not found
any publications from short-term postoperative pain management comparing the respiratory
effect of tapentadol to the traditional opioids.
The aim of the study is to compare the analgesic effect and side-effects of this new
analgesic, tapentadol, to the standard treatment to day, oxycodone, in the acute
postoperative period after hysterectomy.