Pain Clinical Trial
Official title:
Evaluation of the Effect of Ketamine on Remifentanil-induced Hyperalgesia Using Filaments, an Algometer, and Interleukins: a Double-blind, Randomized Study
The aim of this study was to determine if the addition of ketamine reduces remifentanil-induced hyperalgesia, improves its analgesic effect, inhibits IL(interleukin)-6 and IL-8 (inflammatory cytokines), and stimulates IL-10 (an anti-inflammatory cytokine).
Opioids are very effective in pain relief, but they might lower pain threshold, making the
patient more sensitive to a pain stimulus, a condition known as hyperalgesia [Angst; Clarck,
2006]. Opioid-induced hyperalgesia (OIH) is usually defined as a reduction in nociceptive
thresholds in the peripheral field of the sensitized fibers [Koppert et al., 2003], and it
is associated with increased pain and higher demand for postoperative analgesia [Guignard et
al., 2000]. This phenomenon adversely impacts pain control, and has been suggested to occur
in the peri-operative context, especially associated with the use of remifentanil, a
short-acting opioid [Guignard et al., 2000].
Several mechanisms have been proposed to explain the hyperalgesia phenomenon, but the most
important seems to be the activation of N-methyl-D-aspartate (NMDA) receptors [Célèrier et
al., 2000]. Ketamine is a NMDA receptor antagonist that has been shown to reduce
postoperative pain and the need for postoperative anesthetics and analgesics. Therefore, it
is proposed that ketamine could prevent hyperalgesia, resulting in more effective and
long-lasting postsurgical analgesia [Célèrier et al. 2000].
The results of studies of low dose of ketamine in the prevention of remifentanil-induced
hyperalgesia are controversial. Joly et al. [2005] demonstrated a reduction in the
consumption of opioids and in hyperalgesia assessed with monofilaments. However, Engelhardt
et al [2008] showed no differences in pain scores or in postoperative opioid consumption.
In addition, some authors observed higher levels of proinflammatory cytokines, associated
with increased pain in mice receiving chronic opioid (morphine) infusion [Johnston et al.,
2004; Liang et al., 2008]. Also, administration of proinflammatory cytokine inhibitors
reduced phosphorylation of NMDA receptors [Zhang et al., 2008]. However, no study has
examined the relationship between the use of remifentanil, the most frequently implicated
opioid in OIH [Guignard et al., 2000], ketamine (drug capable of inhibiting NMDA-receptors
and cytokines) [Dale et al., 2012], and the inflammatory response.
The aim of this study was to determine if the addition of ketamine reduces
remifentanil-induced hyperalgesia, improves its analgesic effect, inhibits IL-6 and IL-8
(inflammatory cytokines), and stimulates IL-10 (an anti-inflammatory cytokine) in patients
submitted to laparoscopic cholecystectomy, a procedure with an usually neglected potential
for postoperative pain and that has been poorly investigated in association with OIH.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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