No effect of the cyclooxygenase-2 inhibitor etoricoxib on pre-emptive and post-operative analgesia in visceral surgery: results of a randomized controlled trial.

BACKGROUND: Pre-emptive analgesia in perioperative care has potential benefits for patients. The pre-emptive and postoperative analgesic effects of the cyclooxygenase-2 inhibitor etoricoxib have been investigated using a 2 × 2 factorial trial design. METHODS: According to the 2 × 2 factorial study design, 103 patients scheduled for visceral surgery, were randomly allocated to two groups prior to surgery. Patients could receive either etoricoxib or placebo (to investigate pre-emptive analgesia). Subsequent to surgery, patients randomly received either etoricoxib or placebo, again. It follows, that four treatment modalities (continuous or replaced intervention) result, to investigate postoperative analgesia. Main Outcome Measure was the cumulative morphine use 48 h post-surgery. Other outcomes included pain intensities, pain thresholds and sensory detection. RESULTS: Eighty-six patients (female n = 42; mean age 53.82 ± 13.61 years) were evaluated on the basis of an intention to treat analysis. Pre-emptive administration of 120 mg etoricoxib did not significantly reduce the cumulative morphine dose within the first 48 h after surgery, when compared to the administration of placebo. The analysis of the post-operative treatment groups showed a non-significant 8% reduction in morphine dose during the continuous administration of etoricoxib. There were no changes in sensory perception as detected with QST before and after surgery or between groups. CONCLUSIONS: The effect of administering etoricoxib was not superior to placebo in reducing the morphine dose required for postoperative analgesia. The lack of changes in peripheral nociception suggests that central algetic mechanisms are of higher impact in the development of postoperative pain following abdominal or thoracic surgery.

Influence of antiretroviral therapy on immunogenicity of simultaneous vaccinations against influenza, pneumococcal disease and hepatitis A and B in human immunodeficiency virus positive individuals.

OBJECTIVES: Immune response to many vaccinations is impaired in human immunodeficiency virus (HIV) positive patients. METHODS: A total of n = 131 HIV positive patients were vaccinated against influenza, pneumococcal disease, hepatitis A and B, with n = 82 patients (62.6%) receiving 2 or more simultaneous vaccinations. Safety and immunogenicity of simultaneous vaccinations were assessed. Current antiretroviral therapy (ART) regimens were evaluated as potential predictors for antibody response. RESULTS: Immune response rates were 45% (influenza), 68% (pneumococcus), 63.6% (hepatitis A) and 62.5% (hepatitis B). Adverse reactions after vaccination were documented in 2 of 131 patients (1.5%). No statistically significant difference between pre- and post-vaccination CD4+ T-cell counts (CD4) and HIV plasma load was observed. 85% of patients received ART containing nucleotide reverse transcriptase inhibitors, non-nucleotide reverse transcriptase inhibitors and/or protease inhibitors (PI). Higher ratio of CD4 to CD8 and intake of PI were statistically significant, independent predictors for antibody response after influenza vaccination (OR 1.9 and 2.8, p = 0.01 and 0.04, respectively). CONCLUSIONS: Simultaneous vaccinations in HIV positive patients were safe and well tolerated. The positive effect of PI on antibody response after influenza vaccination should be confirmed in larger studies.