Hyperalgesia Clinical Trial
Official title:
Can Opioid-induced Hyperalgesia be Prevented by Gradual Dose Reduction vs. Abrupt Withdrawal of Remifentanil?
Remifentanil is a rapid-acting opioid which has been widely used in pain treatment during
surgery for the last 15 years 1. Remifentanil is rapidly eliminated (minutes) from the body
after end of infusion, and this makes it easily manageable compared to other opioids.
However, there are both experimental and clinical studies indicating that remifentanil,
after end of infusion, triggers increased pain sensation and increased opioid consumption
post-operatively. Increased post-operative opioid consumption should be avoided due to the
adverse effects of these drugs (nausea/vomiting, pruritus, dizziness, fatigue and reduced
respiratory rate). Thus, it's important to investigate relevant strategies to avoid the
increased pain sensation (opioid-induced hyperalgesia = hypersensitivity to pain stimuli)
after end of infusion of remifentanil after surgery. Several experimental and clinical
trials have been conducted in this field. Ketamine has been shown to block this effect, but
its adverse effect profile (i.a. hallucinations) makes it not suitable in normal clinical
use. In a study of healthy volunteers, it has been demonstrated that parecoxib (a COX-2
selective NSAID) can prevent remifentanil-induced hyperalgesia. Our group has previously
shown that a relatively COX-1 selective NSAID (ketorolac) can prevent hyperalgesia in an
experimental pain model.
This is of interest since NSAIDs are frequently administered as premedication before
surgery. There are several disadvantages associated with the use of COX-2 inhibitors, e.g.
the risk of myocardial infarction after long-term use (> 1 year), and potentially reduced
bone healing after orthopedic surgery. However, this has not been shown with short-term use
(days/week). The disadvantages associated with the use of e.g. ketorolac (a COX-1 inhibitor)
are i.a. increased bleeding tendency, which is unfavourable for the surgeon, and increased
risk of gastric ulcer. Therefore, it is of interest to investigate other ways of preventing
opioid-induced hyperalgesia. In a recent animal study it has been shown that gradual dose
reduction of remifentanil (vs. abrupt withdrawal of a relatively high remifentanil dose) can
prevent the development of hyperalgesia after end of infusion. In this study we will i.a.
investigate whether this is also the case in humans. In this new model, the study
participants will get remifentanil infusion with two different dose reduction regimes:
gradual reduction or abrupt withdrawal.
n/a
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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