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Neodolpasse Publications (4)

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Multimodal pain management combines analgesics to improve analgesia and reduce side effects. This study investigates the fixed combination of diclophenac and orphenadrin (Neodolpasse(®) Infusion Solution) in patients after unilateral total hip arthroplasty (THA). This prospective, randomized, double-blind, placebo-controlled, multi-centre clinical study enrolled 120 patients receiving patient-controlled analgesia (PCA). Read More

Isotonic saline was infused as placebo. The primary efficacy goal was defined as reduction of PCA analgesics used over the first 24 h post-surgery. The study used a three-stage group sequential test design with two interim analyses. Analgesia was monitored by visual analogue scale and verbal rating. Infusion of the Neodolpasse(®) Infusion Solution resulted in a significant reduction in the PCA analgesic requirements by approximately 30% (38.7 ± 21.3 mg vs. 55.9 ± 31.1 mg; p = 0.0004) while maintaining adequate analgesia and patient safety. This study demonstrates that Neodolpasse(®) Infusion Solution significantly reduces PCA analgesic requirements without compromising analgesic effectiveness and safety in THA patients.

Blood Coagul. Fibrinolysis

Blood Coagul Fibrinolysis 2007 Dec;18(8):775-80

Department of Anaesthesiology, General Intensive Care, and Pain Control, Vienna Medical University, Vienna, Austria.

Detection of platelet inhibition is of clinical relevance in the preinterventional risk-benefit assessment in chronic low-back-pain patients scheduled for invasive pain therapy. We evaluated the sensitivity of various point-of-care platelet function tests for the detection of platelet inhibition induced by nonopioid analgesic drugs. After Institutional Review Board approval and informed consent, citrated whole blood from 40 patients with chronic unspecific low back pain was investigated before and 30 min after intravenous infusion of the study medication consisting of diclofenac 75 mg (plus orphenadrin 30 mg; Neodolpasse; Fresenius Kabi Austria GmbH, Austria), parecoxib 40 mg (Dynastat; Pharmacia Europe EEIG, UK), paracetamol 1 g (Perfalgan; Bieffe Medital S. Read More

P. A. Italy), or normal saline in a randomized, cross-over, double-blinded, placebo-controlled study. Platelet function was assessed using the PFA-100 platelet function analyzer and thromboelastometry, as well as impedance aggregometry (in the last 17 patients recruited after it became commercially available). Sensitivity for detecting diclofenac-induced platelet inhibition was 85% for the PFA-100 using epinephrine as agonist and 94% for arachidonic acid-induced impedance aggregometry. ADP-induced platelet function tests, as well as cytochalasin D-modified thromboelastometry were unreliable. All tests had a low incidence of false-positive test results after normal saline. Paracetamol and parecoxib had no significant platelet inhibiting effect. The PFA-100 using epinephrine as agonist and arachidonic acid-induced impedance aggregometry are recommended for the detection of cyclooxygenase-I-inhibiting effects of nonsteroidal anti-inflammatory drugs such as diclofenac. Our findings confirm that a single rescue dose of paracetamol and parecoxib has no antiplatelet effect.

Drugs R D 2005 ;6(4):189-99

HPR--Human Pharmacodynamic Research GmbH, Munich, Germany.

The aim of this study was to investigate the analgesic efficacy of Neodolpasse, a fixed-dose combination of orphenadrine and diclofenac, compared with those of its single active ingredients in a human pain model. The study was designed as a randomised, double-blind, placebo-controlled, four-period crossover study. Twenty-four healthy female and male subjects received single infusions of Neodolpasse, orphenadrine, diclofenac or saline solution over 60 minutes. Read More

Infusions were separated by a 1-week washout period. Neurogenic inflammation and hyperalgesia were induced by topical occlusive application of a 1% capsaicin solution for 30 minutes on defined skin areas on the back. The pain response to CO2 laser pulses applied to the capsaicin-pretreated skin was measured by event-related vertex EEG recordings. This allowed us to study the influence of a single infusion on the central P2- and peripheral N1-components of laser-induced somatosensory-evoked potentials (LSEP) as a measure of pain response. Although none of the active treatments had a significant effect on the peripheral N1-component, all active treatments reduced the P2-component of the LSEP, reflecting central/spinal analgesic (anti-hyperalgesic) effects. These effects were statistically significant for orphenadrine (p

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