Dexketoprofen/tramadol 25 mg/75 mg: randomised double-blind trial in moderate-to-severe acute pain after abdominal hysterectomy

Abstract

BackgroundDexketoprofen trometamol plus tramadol hydrochloride is a new oral combination of two analgesics, which have different mechanisms of action for the treatment of moderate to severe acute pain.MethodsRandomised, double-blind, parallel, placebo and active-controlled, single and multiple-dose study to evaluate the analgesic efficacy and safety of dexketoprofen/tramadol 25 mg/75 mg in comparison with the single agents (dexketoprofen 25 mg and tramadol 100 mg) in moderate to severe acute pain after abdominal hysterectomy.Patients received seven consecutive doses of study drug within a 3-day period, each dose separated by an 8-hour interval. A placebo arm was included during the single-dose phase to validate the pain model.Efficacy assessments included pain intensity, pain relief, patient global evaluation and use of rescue medication. The primary endpoint was the mean sum of pain intensity differences over the first 8 h (SPID8).ResultsThe efficacy analysis included 606 patients, with a mean age of 48 years (range 25–73). The study results confirmed the superiority of the combination over the single agents in terms of the primary endpoint (p <0.001). Secondary endpoints were generally supportive of the superiority of the combination for both single and multiple doses.Most common adverse drug reactions (ADRs) were nausea (4.6 %) and vomiting (2.3 %). All other ADRs were experienced by less than 2 % of patients.ConclusionsThe study results provided robust evidence of the superiority of dexketoprofen/tramadol 25 mg/75 mg over the single components in the management of moderate to severe acute pain, as confirmed by the single-dose efficacy, repeated-dose sustained effect and good safety profile observed.Trial registrationEU Clinical Trials Register (EudraCT number 2012-004545-32, registered 04 October 2012); Clinicaltrials.gov (NCT01904149, registered 17 July 2013).Electronic supplementary materialThe online version of this article (doi:10.1186/s12871-016-0174-5) contains supplementary material, which is available to authorized users.

Evaluation of the effectiveness of the Quadratus Lumborum Block type I using ropivacaine in postoperative analgesia after a cesarean section — a controlled clinical study

“…The side effects and limits in systemic and intrathecal usage of opioids after a C-section are: respiratory depression, nausea and vomiting, itching, excessive sedation, slowing peristaltic intestine activity and pruritus [19]. One cannot ignore the possibility of using Tramadol, which, in many cases of post-operative pain therapy after laparotomy, is more positive than morphine because, for example, there is less risk of pruritus and of respiratory depression [20]. Regional anesthesia used with non-opioid analgesics aims to reduce the total dose of opioids taken by patients during both the intra-and post-operative periods, which is the main point of multimodal analgesia [8].…”

“…Over the next 48 hours, all patients received 1 g of paracetamol iv at constant intervals of time (every 6 hours) and 5 mg of morphine subcutaneously depending on their intensity of pain (NRS > 3), or, on demand with the proviso of a 4-hour administration frequency. Next, the the level of pain intensity was evaluated, only in rest among the newly delivered mothers (using NRS scale 0-10 in which 0 = no pain and 10 = worst pain imaginable) and consecutively after 2,4,8,12,16,20,24,30,36, 42 and 48 hours. At every postoperative time-point the following parameters were measured: sedation (Ramsey scale); nausea, vomiting and itching (0 = none, 1 = mild, 2 = moderate, 3 = severe); the possibility of the free movement of limbs or any other possible side effects.…”

What place is there for tramadol/dexketoprofen?

“…The review included three randomised double-blind controlled trials, involving a total of 1,853 participants who had undergone surgery for removal of impacted wisdom teeth (who received only a single dose of the trial medication),4 hysterectomy (participants received study medication every 8 hours for 3 days)7 or hip replacement (participants received study medication every 8 hours for 5 days) 8. The main exclusion criteria for the studies were a contraindication to any of the study medication, a significant medical condition that might interfere with the study, including moderate or severe renal dysfunction, severe hepatic or cardiac dysfunction, chronic opioid use, a history of gastrointestinal disorder or drug or alcohol abuse 1.…”

Refuerzo de la vía oral como actitud de cara al futuro. Edad avanzada

“…Tramadol en combinación con dexketoprofeno trometamol (DT) es una combinación analgésica en una misma presentación farmacéutica que se ha indicado en dolor moderado-intenso (51). El dexketopreno es un antinflamatorio no esteroideo de acción periférica que tiene como característica ser de inicio rápido.…”