caa a22 4500 47705644X CHVBK 20180405111347.0 cr unu---uuuuu 170330e19960901xx s 000 0 eng 10.1007/s002280050156 doi (NATIONALLICENCE)springer-10.1007/s002280050156 Asessment of analgesia in man: tramadol controlled release formula vs. tramadol standard formulation [Elektronische Daten] [T. Hummel, S. Roscher, E. Pauli, M. Frank, J. Liefhold, W. Fleischer, G. Kobal] Objective: The present study tested analgesia produced by a new controlled release formulation of tramadol. The investigation employed an experimental pain model based on chemo-somatosensory event-related potentials (CSSERP) in response to painful chemical stimuli applied to the nasal mucosa. Study: Twenty healthy volunteers participated in the experiments, which followed a controlled, randomised, double-blind, 3-way cross-over design. Each of the three medications (tramadol 100 mg [T100], tramadol controlled release 100 mg [TCR100] and tramadol controlled release 150 mg [TCR150]) was administered orally to fasting subjects. There was at least a 6 day washout period between tests. Each experiment was divided into five sessions, which took place before and 2, 4, 6, and 12 h after drug administration. In addition to the assessment of CSSERP, subjects rated the intensity of both the tonic and phasic painful stimuli. Nonspecific drug effects were also monitored by means of frequency analysis of the spontaneous EEG, ratings of adverse effects, and the subjects' performance in a tracking task. Results: The significant reduction of amplitude N1 at central recording positions indicated that TCR150 was the most effective analgesic 12 h after administration. Both 6 and 12 h after administration TCR100 was more effective in terms of analgesia compared to T100. In addition, TCR100 appeared to produce fewer adverse effects than the standard formulation of tramadol. Conclusions: The controlled release formulation can be expected to become a valuable tool in peroral therapeutic regimens for chronic pain. Springer-Verlag Berlin Heidelberg, 1996 Key words Nociception nationallicence Tramadol nationallicence chemo-somato-sensory event-related potential nationallicence innervation nationallicence trigeminal nationallicence opioid nationallicence controlled release formulation nationallicence Hummel T. Department of Experimental and Clinical Pharmacology and Toxicology, University of Erlangen-Nürnberg, Krankenhausstrasse D-9, 91054 Erlangen, FRG, XX aut Roscher S. Department of Experimental and Clinical Pharmacology and Toxicology, University of Erlangen-Nürnberg, Krankenhausstrasse D-9, 91054 Erlangen, FRG, XX aut Pauli E. Department of Neurology, University of Erlangen-Nürnberg, Schwabachanlage 6, D-91054 Erlangen, FRG, XX aut Frank M. Department of Medicine, Research and Development, Mundipharma GmbH, Mundipharmastrasse 2, D-65549 Limburg, FRG, XX aut Liefhold J. Department of Medicine, Research and Development, Mundipharma GmbH, Mundipharmastrasse 2, D-65549 Limburg, FRG, XX aut Fleischer W. Department of Medicine, Research and Development, Mundipharma GmbH, Mundipharmastrasse 2, D-65549 Limburg, FRG, XX aut Kobal G. Department of Experimental and Clinical Pharmacology and Toxicology, University of Erlangen-Nürnberg, Krankenhausstrasse D-9, 91054 Erlangen, FRG, XX aut https://doi.org/10.1007/s002280050156 text/html Onlinezugriff via DOI 1 research-article jats NATIONALLICENCE 856 40 https://doi.org/10.1007/s002280050156 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Hummel T. Department of Experimental and Clinical Pharmacology and Toxicology, University of Erlangen-Nürnberg, Krankenhausstrasse D-9, 91054 Erlangen, FRG, XX aut NATIONALLICENCE 700 1- Roscher S. Department of Experimental and Clinical Pharmacology and Toxicology, University of Erlangen-Nürnberg, Krankenhausstrasse D-9, 91054 Erlangen, FRG, XX aut NATIONALLICENCE 700 1- Pauli E. Department of Neurology, University of Erlangen-Nürnberg, Schwabachanlage 6, D-91054 Erlangen, FRG, XX aut NATIONALLICENCE 700 1- Frank M. Department of Medicine, Research and Development, Mundipharma GmbH, Mundipharmastrasse 2, D-65549 Limburg, FRG, XX aut NATIONALLICENCE 700 1- Liefhold J. Department of Medicine, Research and Development, Mundipharma GmbH, Mundipharmastrasse 2, D-65549 Limburg, FRG, XX aut NATIONALLICENCE 700 1- Fleischer W. Department of Medicine, Research and Development, Mundipharma GmbH, Mundipharmastrasse 2, D-65549 Limburg, FRG, XX aut NATIONALLICENCE 700 1- Kobal G. Department of Experimental and Clinical Pharmacology and Toxicology, University of Erlangen-Nürnberg, Krankenhausstrasse D-9, 91054 Erlangen, FRG, XX aut Metadata rights reserved Springer special CC-BY-NC licence nationallicence BK010053 XK010053 XK010000 NATIONALLICENCE NATIONALLICENCE NL-springer