Background: Dexketoprofen trometamol (DKP.TRIS) is the tromethamine salt of dexketoprofen, the S-enantiomer responsible for the pharmacological activity of ketoprofen. DKP.TRIS has rapid absorption and onset of action in pain relief. Objective: To compare the efficacy and tolerability of DKP.TRIS and diclofenac, a nonsteroidal anti-inflammatory drug widely accepted as reference therapy for symptomatic treatment of osteoarthritis, in patients with chronic pain due to knee osteoarthritis. Design: This was a multicentre, randomised, comparative, double-blind study. Methods: Radiological evidence of osteoarthritis, shown by the presence of Kellgren grade 2 to 4 changes, was required. Patients were evaluated before and after a washout period of 7 to 14 days and after 1 and 2 weeks of treatment with DKP.TRIS 25 mg three times daily orally or diclofenac 50 mg three times daily orally. Primary end-points were reduction of pain measured on a visual analogue scale (VAS, 0 to 100 mm) and disability measured by the Lequesne index of severity for knee osteoarthritis (ISK). Tolerability was evaluated by laboratory parameters and frequency and nature of adverse events. Results: Of 117 patients recruited to the study, 115 were treated (61 with DKP.TRIS, 54 with diclofenac) and 99 (54/45) completed the 2-week treatment period. Patient characteristics were homogenous between groups. Pain measured on the VAS decreased by 43% from 61.7 ± 18.5 mm (mean ± SD) at baseline to 34.7 ± 22.3 mm at the end of treatment with DKP.TRIS compared with a 29% decrease from 62.1 ± 22.7 mm to 40.6 ± 22.2 mm for diclofenac [p = 0.027; 95% confidence interval (CI) for the difference between treatments: 1.7, 27.9]. Median ISK scores improved from 11 (range 9 to 12) to 8 (6 to 10) in the DKP.TRIS group versus 10.75 (9 to 12.5) to 8.5 (6 to 10.5) in the diclofenac group. There were no group differences for secondary end-points. Adverse events were comparable overall between groups. Conclusion: Oral DKP.TRIS 25 mg three times daily is at least as effective as diclofenac 50 mg three times daily for the short term treatment of pain in patients with osteoarthritis of the knee.
OBJECTIVE: The aim of this study was to assess the efficacy and safety of a single intravenous (i.v.) bolus of dexketoprofen trometamol compared with an i.v. infusion of dipyrone in patients with moderate to severe pain due to renal colic.
METHODS: A total of 308 patients with renal colic and visual analog scale (VAS) score >/=40 mm participated in a multicenter, randomized, double blind, double-dummy, parallel, and active-controlled study and were randomized to dexketoprofen 25 mg (n = 101), dexketoprofen 50 mg (n = 104), and dipyrone 2 g (n = 103).
RESULTS: Mean [+/- standard deviation (SD)] total pain relief (TOTPAR) scores were similar in the dexketoprofen 50 mg (15.3 +/- 8.6) and dipyrone (15.5 +/- 8.6) and slighly higher than in dexketoprofen 25 mg (13.5 +/- 8.6), although significant differences were not achieved. In the same way, patients in the dexketoprofen 50 mg and dipyrone groups showed higher scores in the sum of pain intensity differences (SPID) and the sum of analogue pain intensity differences (SAPID) than patients in the dexketoprofen 25 mg group, reaching statistical significance in comparison with dexketoprofen 25 mg and dipyrone for SPID and SAPID (p < 0.05). The time-effect course for pain intensity differences and pain relief showed significantly higher values for both doses of dexketoprofen during the first 30 min after drug administration (p < 0.05). Dexketoprofen 50 mg and dipyrone groups had 66% and 70%, respectively, of patients with at least 50% of maximum obtainable TOTPAR in comparison with 56% in the dexketoprofen 25 mg group. The study medications were well tolerated.
CONCLUSIONS: Dexketoprofen 50 mg administered as a single i.v. bolus was effective for the relief of moderate to severe pain in patients with renal colic, with a good safety profile and efficacy similar to i.v. dipyrone 2 g. Dexketoprofen produced analgesia that was faster in onset.
BACKGROUND: Low back pain is an important medical problem in Western industrialised countries. NSAIDs are one of the main options for symptomatic pain relief in the early management of this painful condition. Dexketoprofen is an NSAID belonging to the arylpropionic acid group that has demonstrated good analgesic efficacy and a good safety profile in different acute and chronic painful conditions.
METHODS: A randomised, double-blind, parallel, active controlled, multicentre study that included 370 outpatients with acute low back pain was conducted to compare the analgesic efficacy of dexketoprofen 50mg twice daily versus diclofenac 75mg twice daily administered intramuscularly for 2 days. Efficacy outcomes were assessment of pain intensity (PI) measured on a visual analogue scale, total PI scores from baseline to 6 hours after the first-dose administration (primary efficacy endpoint; SAPID(0-6)), score on a physical disability scale using the Roland Disability Questionnaire (RDQ), and use of rescue medication. Tolerability and safety were also assessed as secondary variables.
RESULTS: The adjusted mean (SAPID(0-6)) scores were very similar, 117.3 mm/h with dexketoprofen and 114.7 mm/h with diclofenac. The adjusted ratio of means was 1.023 and the lower 95% confidence limit was 0.81, demonstrating non-inferiority of dexketoprofen (defined by a lower limit of the 95% CI >0.80) in comparison with diclofenac (per-protocol analysis). The median change in the RDQ was -6 points for both groups (p = 0.69), showing an overall improvement on the disability scale. No significant differences between groups were observed regarding the percentage of patients needing rescue medication or in the mean values of pain after repeated doses (SAPID(0-last)). Dexketoprofen was well tolerated, with a reported incidence of adverse events similar to that of diclofenac. No serious adverse events were reported in either treatment group.
CONCLUSION: From the results of this study it can be concluded that dexketoprofen 50mg administered twice daily intramuscularly provides a clinically relevant analgesic effect with good tolerability after single and repeated doses in patients with acute severe low back pain.
OBJECTIVE: This study aimed to evaluate the analgesic efficacy and tolerability of dexketoprofen trometamol, a nonsteroidal anti-inflammatory drug, in comparison with that of racemic ketoprofen (both administered by intravenous infusion), in patients with postoperative pain.
METHODS: This was a multicentre, randomised, double-blind, parallel-group study. 252 patients with moderate to severe pain following hip or knee replacement surgery performed under general anaesthesia were randomly assigned to receive either dexketoprofen trometamol 50 mg or ketoprofen 100 mg, both administered by intravenous infusion every 8 hours over 2 days. A level of > or =40 mm on a 100 mm visual analogue scale (VAS) for pain was required for inclusion in the study. Pain intensity on the VAS at different time-points after the administration of the first dose was assessed and the sum of pain intensity differences (SAPID(0-8 h)) was calculated as the primary efficacy variable. The use of rescue medication, maximum pain intensity difference (PID(max)), time to PID(max) and safety were also evaluated.
RESULTS: The mean (+/- SE) adjusted SAPID(0-8 h) scores in the per-protocol population were 310.9 +/- 19.2 and 326.3 +/- 19.0 mm x h after dexketoprofen trometamol and ketoprofen treatment, respectively. The 95% CI for the difference between treatments (-59.1 to 28.3) was fully included within the range of equivalence of +/-65.3 mm x h. There were no significant differences with regard to secondary variables. The need for rescue analgesia was high in both groups; 81.3% of patients receiving dexketoprofen trometamol treatment and 87.1% receiving ketoprofen treatment required rescue analgesia. The time to achieve PID(max) was 284.7 and 308.5 min after dexketoprofen and ketoprofen, respectively. Treatment- related adverse events were experienced by 16% of patients in the dexketoprofen trometamol group compared with 21.3% in the ketoprofen group. Most patients were concomitantly treated with low-molecular-weight heparin (94.4%), and no haemorrhagic events related to the surgical procedure were reported. No adverse events related to renal function were detected during the study.
CONCLUSION: The two medications were equivalent in terms of analgesic activity in the management of postoperative pain after orthopaedic surgery. The high use of rescue analgesics indicates a need for a multimodal approach to analgesia in this type of surgery. Dexketoprofen trometamol appeared to show a trend towards a better tolerability profile compared with the racemic compound.
Dexketoprofen trometamol is a water-soluble salt of the dextrorotatory enantiomer of nonsteroidal anti-inflamatory drug ketoprofen. The aim of the study was to investigate the effect of dexketoprofen on postoperative pain. This study was performed on 50 (ASA I-II) patients planned for abdominal hysterectomy. Fifty patients were randomized into two equal groups. Patients received oral placebo (group I) and 25 mg dexketoprofen (group II) 1h before surgery and 8 -16 h after surgery. All patients received a standard anesthetic protocol. At the end of surgery, all patients received tramadol IV via a PCA (Patient Controlled Analgesia) -device. Pain scores and sedation scores were assessed at 3, 6, 12 and 24 h after surgery. Tramadol consumption, adverse effects, and patient satisfaction were noted during 24 h after the surgery. The pain scores were significantly lower in the dexketoprofen group compared with the placebo group (p<0.05). The cumulative tramadol consumption was lower in the dexketoprofen group than placebo group (p<0.05). No significant difference was observed in sedation scores, adverse effects and patient satisfaction between the groups (p>0.05). We conclude that the preoperative and postoperative administration of dexketoprofen provided a significant analgesic benefit and decreased the opioid requirements in patients undergoing abdominal hysterectomy.
ZIELE: Vergleichen Sie die analgetische Wirksamkeit von zwei nichtsteroidale entzündungshemmende Medikamente (NSAIDs) zur Familie der Propionsäure nach oraler Chirurgie gehören, um zu beurteilen, was man am effektivsten mit den minimalen Nebenwirkungen und die niedrigste Dosis ist. Normalerweise wird der Schmerz nach der oralen Chirurgie als moderat-intensive berücksichtigt und NSAIDs sind die erste Wahl bei der Behandlung von postoperativen Zahnschmerzen. Wie wir wissen, ist das große Problem dieser Medikamente in ihrer unerwünschten Wirkungen gefunden. Das Enantiomer-S (+) Komponente bekannt mit Analgesie bezogen werden und die Notwendigkeit einer geringeren Dosis dieser Arzneimittel.
DESIGN: Die Patienten gegeben werden Fragebögen mit Schmerzbeurteilung Tabellen und verschiedene Beobachtungen gemacht: postoperative Schmerzen, Schmerzen in der ersten Stunde nach der Einnahme des Schmerzmittels, Entzündungen, Blutungen, Hämatome etc. Wir beurteilen die Wirkung der verschiedenen Medikamente in die verwendete Studie über die Wirksamkeit-Zeit-Koordinaten sowie die anti-inflammatorische Wirkung und ihre Nebenwirkungen.
ERGEBNISSE: Es ist nachgewiesen, dass es moderate Schmerzen nach der Oralchirurgie und die verwendeten Medikamente wirksam in den Dosen und Intervalle angegeben sind. Während der ersten Stunde nach der Einnahme der schmerzlindernd, präsentiert die Patienten mit Dexketoprofen Trometamol (DKT) behandelt weniger Schmerzen im Vergleich zu denen, die mit Ibuprofen (IBU) behandelt wurden. Es ist nachgewiesen, dass es Entzündungen in den meisten Interventionen, die Extraktionen der Halb beeinflusst Weisheitszähne (SITM) vorhanden größere Blutung am ersten Tag und die Extraktionen der betroffenen dritten Molaren (ITM) vorhanden mehr Blutungen am dritten Tag. Diese letzten beiden Interventionen (ITM) ebenfalls anwesend Hämatom.
SCHLUSSFOLGERUNGEN: Es zeigen die stärkere analgetische Wirksamkeit von Dexketoprofen Trometamol in der ersten Stunde nach der oralen chirurgischen Eingriff und seine größere entzündungshemmende Wirkung.
HINTERGRUND: Rofecoxib, ein selektiver Cyclooxygenase-2-Inhibitor, und Dexketoprofen Trometamol, ein einzelnes Isomer nicht-steroidale entzündungshemmende Arzneimittel (NSAID), sind für die Behandlung von akuten Schmerzen. Beide sind angeblich weniger Nebenwirkungen als herkömmliche NSAR haben. Wir haben sie in einer klinischen Umgebung verglichen. Methoden: Wir führten eine doppelblinde, randomisierte, kontrollierte Studie mit 120 Patienten, bei denen eine chirurgische Entfernung eines einzelnen unteren Weisheitszahnes auf dem Edinburgh Dental Institute. Diejenigen, die mäßige Schmerzen innerhalb von 4 h des Verfahrens entwickelt wurden, um eine von drei Gruppen zugeteilt: 50 mg Rofecoxib (Gruppe RO, n = 37); Dexketoprofen-Trometamol 25 mg (Gruppe DE, n = 42) oder Placebo (Gruppe PL, n = 41). Die Teilnehmer überwacht Schmerzintensität und Schmerzlinderung für 24 h mit Hilfe einer visuellen Analogskala (VAS) und verbalen Rating-Skalen (VRS). Das summiert, zeitlich gewichtete Schmerzlinderung Punktzahl zu 8 h von den VRS (TOTPAR 8) abgeleitet wurde als primäre Zielgröße verwendet. Ergebnisse: Kein signifikanter Unterschied zwischen Gruppen RO und DE mit TOTPAR 8 als primäre Zielgröße demonstriert. Beide Medikamente waren signifikant unterschiedlich im Vergleich zu Placebo. Rettung Analgesie während der Probezeit wurde von nur 15 von 37 Probanden in der Gruppe RO, aber 35 von 42 Probanden in der Gruppe DE erforderlich. Die medianen Zeiten bis der Notfallmedikation waren 150 (Gruppe PL), 398 (Gruppe DE) und 1440 min (Gruppe RO). Beide Medikamente wurden gut vertragen und Nebenwirkungen waren mild bis mäßig ausgeprägt. FAZIT: Rofecoxib und Dexketoprofen-Trometamol sind wirksame Behandlungen für akute Schmerzen mit Hilfe eines Zahnschmerzen Modell und sind gut verträglich. Rofecoxib hat eine längere Wirkungsdauer als Einzeldosis und gab eine ausreichende Analgesie für mehr als die Hälfte dieser Studiengruppe; Patienten in der Dexketoprofen-Trometamol Gruppe brauchte mehr Rettungs-Analgesie.
AIMS: Multimodal analgesia is thought to produce balanced and effective postoperative pain control. A combined therapy with nonsteroidal anti-inflammatory drugs (NSAIDs) and opiates could result in synergistic analgesia by acting through different mechanisms. Currently there are very few parenterally administered NSAIDs suitable for the immediate postoperative period. Therefore, this study was undertaken to assess the analgesic efficacy, relative potency, and safety of parenteral dexketoprofen trometamol following major orthopaedic surgery.
METHODS: One hundred and seventy-two patients elected for prosthetic surgery, were randomized to receive two intramuscular injections (12 hourly) of either dexketoprofen 50 mg, ketoprofen 100 mg or placebo in a double-blind fashion. Postoperatively, the patient's pain was stabilized, then they were connected to a patient- controlled analgesia system (PCA) of morphine for 24 h (1 mg with 5 min lockout).
RESULTS: The mean cumulative amount of morphine (CAM) used was of 39 mg in the dexketoprofen group and 45 mg in the ketoprofen group vs 64 mg in the placebo group. (Reduction in morphine use was approximately one-third between the active compounds compared with placebo (adjusted mean difference of -25 mg between dexketoprofen and placebo and -23 mg between ketoprofen and placebo. These differences were statistically significant: P </= 0.0003; 95% CI -35, -14. Pain-intensity scores were consistently lower with the active compounds, the lowest corresponded to the dexketoprofen-treated patients. Regarding sedation, there were statistically significant differences between the two active compounds and placebo only at the 2nd and 13th hours. Wound bleeding was specifically measured with no statistically significant differences found between all the groups.
CONCLUSIONS: Intramuscular administration of dexketoprofen trometamol 50 mg has good analgesic efficacy both in terms of opioid-sparing effect and control of pain after major orthopaedic surgery.
The analgesic efficacy and safety of dexketoprofen trometamol (the active enantiomer of the racemic compound ketoprofen) (25mg q.i.d.) vs. ketorolac (10mg q.i.d.) was assessed in 115 patients with bone cancer pain included in a multicenter, randomized, double-blind, parallel group study. A level of >/=40 mm on the 100 mm visual analog scale (VAS) and >/=10 in the pain rating index were required for inclusion. At the end of treatment on day 7 (+1 day), mean values of VAS were 32+/-24 mm for dexketoprofen and 40+/-30 mm for ketorolac (P=0.12) but the pain rating index was significantly lower in patients given dexketoprofen (8.5+/-2.3 vs. 9.7+/-2.9, P=0.04). Moreover, most of the patients reached a pain intensity difference from baseline >/=20 mm (75% of patients for dexketoprofen and 65% of patients for ketorolac). Around half of patients in both treatments had a pain intensity <30 mm on VAS at the end of treatment (55% for dexketoprofen and 47% for ketorolac). In the overall assessment of efficacy, a higher percentage of both patients and physicians rated dexketoprofen as 'quite effective' or 'very effective' compared to ketorolac. The percentage of patients withdrawn from the study for any reason as well as for insufficient therapeutic effect or due to adverse events was lower in the dexketoprofen group than in the ketorolac group. Treatment-related adverse events occurred in 16% of patients given dexketoprofen and in 24% given ketorolac. Serious adverse events occurred in 3.5% of patients from both groups but only one case of gastrointestinal hemorrhage was considered related to ketorolac. We conclude that dexketoprofen trometamol 25 mg q.i.d. oral route is a good analgesic therapy in the treatment of bone cancer pain, comparable to ketorolac 10 mg q.i.d., with a good tolerability profile.
Background: Dexketoprofen trometamol (DKP.TRIS) is the tromethamine salt of dexketoprofen, the S-enantiomer responsible for the pharmacological activity of ketoprofen. DKP.TRIS has rapid absorption and onset of action in pain relief. Objective: To compare the efficacy and tolerability of DKP.TRIS and diclofenac, a nonsteroidal anti-inflammatory drug widely accepted as reference therapy for symptomatic treatment of osteoarthritis, in patients with chronic pain due to knee osteoarthritis. Design: This was a multicentre, randomised, comparative, double-blind study. Methods: Radiological evidence of osteoarthritis, shown by the presence of Kellgren grade 2 to 4 changes, was required. Patients were evaluated before and after a washout period of 7 to 14 days and after 1 and 2 weeks of treatment with DKP.TRIS 25 mg three times daily orally or diclofenac 50 mg three times daily orally. Primary end-points were reduction of pain measured on a visual analogue scale (VAS, 0 to 100 mm) and disability measured by the Lequesne index of severity for knee osteoarthritis (ISK). Tolerability was evaluated by laboratory parameters and frequency and nature of adverse events. Results: Of 117 patients recruited to the study, 115 were treated (61 with DKP.TRIS, 54 with diclofenac) and 99 (54/45) completed the 2-week treatment period. Patient characteristics were homogenous between groups. Pain measured on the VAS decreased by 43% from 61.7 ± 18.5 mm (mean ± SD) at baseline to 34.7 ± 22.3 mm at the end of treatment with DKP.TRIS compared with a 29% decrease from 62.1 ± 22.7 mm to 40.6 ± 22.2 mm for diclofenac [p = 0.027; 95% confidence interval (CI) for the difference between treatments: 1.7, 27.9]. Median ISK scores improved from 11 (range 9 to 12) to 8 (6 to 10) in the DKP.TRIS group versus 10.75 (9 to 12.5) to 8.5 (6 to 10.5) in the diclofenac group. There were no group differences for secondary end-points. Adverse events were comparable overall between groups. Conclusion: Oral DKP.TRIS 25 mg three times daily is at least as effective as diclofenac 50 mg three times daily for the short term treatment of pain in patients with osteoarthritis of the knee.
