Formulation , development , and evaluation of tramadol Hcl sustained-release dosage form (original) (raw)
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Pain is defined by the International Association for the Study of Pain (IASP) as "an unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage". Pain has now been equated to a " fifth vital sign " highlighting the significance of pain management in patient care. Tramadol is a centrally acting analgesic, structurally related to codeine and morphine .It is effectively used to treat moderate-to-severe acute and chronic pain in diverse conditions. Tramadol is placed on the second step of WHO analgesic ladder and in contrast to traditional opioids, exerts its analgesic activity, a dual mechanism of action inhibiting transmission as well as perception of pain. Tramadol is more suitable than NSAIDs and coxibs for patient with GI, renal and cardiovascular problems. Combined with low dependence/abuse potential, it has proven to be of significant advantage over other agents, especially in the elderly.
Tramadol Safer and Effective Analgesic to Treat Chronic Pain: A Review
International Journal of Biomedical and Advance Research, 2012
Pain is defined by the International Association for the Study of Pain (IASP) as "an unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage". Pain has now been equated to a "fifth vital sign" highlighting the significance of pain management in patient care. Tramadol is a centrally acting analgesic, structurally related to codeine and morphine .It is effectively used to treat moderate-to-severe acute and chronic pain in diverse conditions. Tramadol is placed on the second step of WHO analgesic ladder and in contrast to traditional opioids, exerts its analgesic activity, a dual mechanism of action inhibiting transmission as well as perception of pain. Tramadol is more suitable than NSAIDs and coxibs for patient with GI, renal and cardiovascular problems. Combined with low dependence/abuse potential, it has proven to be of significant advantage over other agents, especially in the elderly.
Canadian Journal of Anaesthesia-journal Canadien D Anesthesie, 1998
Purpose To compare the efficacy of tramadol and morphine for intra-and postoperative analgesia in patients undergoing laparoscopic cholecystectomy. Methods In a prospective, randomized, double-blind study 100 patients were allocated randomly into two groups. Ten minutes before induction of anaesthesia, patients in group I received 100 mg tramadol and those in group 2 received 10 mg morphineiv. Anaesthesia was induced with 5 mg·kg−1 thiopental and was maintained with O2, N2O plus isoflurane with additional doses of tramadol or morphine as decided by the attending anaesthetist. Postoperatively, patients in group I and group 2 received tramadol and morphine, respectively, from a patient-controlled analgesia (PCA) device. Pain, analgesic consumption, vital signs and side effects were recorded postoperatively for 24 hr. Results Intraoperative consumption of tramadol and morphine were 137 ± 37 and 12.2 ± 3 mg, respectively. Compared with morphine, patients receiving tramadol had higher blood pressures and required greater mean ETiso to control haemodynamic variables (P P Conclusions There was no difference between the use of tramadol and morphine to treat pain after laparoscopic cholecystectomy from 90 min after the end of surgery. Morphine was more effective than tramadol as an intraoperative analgesic. Objectif Comparer l’efficacité du tramadol et de la morphine pour l’analgésie peropératoire et postopératoire de patients devant subir une cholécystectomie laparoscopique. Méthode Lors d’une étude prospective, randomisée et en double aveugle, 100 patients ont été répartis au hasard en deux groupes. Dix minutes avant l’induction de l’anesthésie, les patients du groupe I ont reçu 100 mg de tramadol et ceux du groupe 2, 10 mg de morphineiv. Lanesthésie a été induite avec 5 mg·kg−1 de thiopental et a été maintenue avec un mélange d’O2 et de N2O plus de l’isoflurane et des doses supplémentaires de tramadol ou de morphine selon la décision de l’anesthésiste traitant. Après l’intervention, les patients des groupes 1 et 2 ont reçu respectivement du tramadol et de la morphine à l’aide d’un dispositif d’analgésie contrôlée par le patient (ACP). En période postopératoire également, on a enregistré pendant 24 heures la douleur, la consommation d’analgésiques, les signes vitaux et les effets secondaires. Résultats La consommation peropératoire de tramadol et de morphine a été de 137 ± 37 et de 12,2 ± 3 mg, respectivement. Comparativement, les patients qui ont reçu du tramadol ont présenté une tension artérielle plus élevée et ont eu besoin d’isofluraneTE (télé-expiratoire) de moyenne plus élevée pour contrôler les variables hémo-dynamiquesP P Conclusion À partir de 90 min après la chirurgie, il n’y a pas de différence entre l’usage de tramadol ou de morphine pour traiter la douleur consécutive à la cholécystectomie laparoscopique. La morphine a été plus efficace que le tramadol en tant qu’analgésique peropératoire.
Pain, 1995
Tramadol hydrochloride is a synthetic CL-opioid agonist with additional monoaminergic activity. Tramadol's analgesic effect has been equated with that of pethidine, with a more favourable side-effect profile. Tramadol has been the most-selling prescription analgesic in Germany for several years, and it is now available in many other European countries, but stil1 there is a lack of adequately controlled clinical studies of its analgesic properties. The purpose of this study was to compare the analgesic efficacy of 50 and 100 mg oral tramadol with our standard analgesic for postoperative pain treatment, 1000 mg paracetamol + 60 mg codeine, and placebo. A single-dose, parallel group, double-blind design was used. One hundred forty-four patients were enrolled the day after total hip replacement if they had a pain intens@ of 60 mm or more on a 0-100 mm visual analogue scale. Treatments were compared on the basis of pain intensity and derived variables (pain intensity differente, and summed pain intensity differences), the need of rescue medication, and a global evaluation. Serum concentrations confirmed rapid and good absorption comparable with that reported in healthy volunteers. The active drug control, paracetamol + codeine, was significantly superior to placebo for al1 efficacy variables CP = 0.0002-0.004), confirming good assay sensitivity. Paracetamol + codeine was also significantly superior to both 50 mg tramadol CP = 0.002-0.03) and 100 mg tramadol (P = 0.002-0.02). There was no differente between placebo and 50 and 100 mg tramadol for any of the efficacy variables. Adverse events were more common with tramadol than with the active control CP < 0.021, with significantly more emetic episodes after 50 and 100 mg tramadol (P < 0.05). Thus, this double-blind, placebo-and active drug-controlled study after orthopaedic surgery shows that 50 and 100 mg oral tramadol is wel1 absorbed but has no significant analgesic effect in doses that are tolerable as single doses by mouth. We emphasize the importante of proper study design with documented assay sensitivity and sufficiently high initial pain intensity for differentiation between analgesics of different potenties.
Safety and Efficacy of Tramadol Compared to Diclofenac in Relieving Postoperative Pain
2015
BACKGROUND: Effective postoperative pain control is an essential component of the care of the surgical patient. Inadequate pain control, apart from being inhumane, may result in increased morbidity or mortality. Opioids have been the mainstay of treatment for postoperative pain but their side effects such as respiratory depression, sedation, constipation, urinary retention, nausea, vomiting, hypotension, bradycardia, and itching limit their use. Tramadol is a semi-synthetic opiate which has the advantage of less respiratory depression (<1%) besides its good analgesic effect. Non-steroidal anti-inflammatory drugs (NSAIDs) have recently gained wide spread popularity in postoperative pain management. Most NSAIDs have been used for treatment of postoperative pain. However, associated side effects include peptic ulcer disease, gastrointestinal hemorrhage, renal dysfunction, altered liver function, and platelet dysfunction. OBJECTIVE: The objective of this study was to compare the effi...
Acta Anaesthesiologica Scandinavica, 1998
Background: Tramadol is an analgesic with combined opioid agonist and monoamine reuptake blocker properties, which may be useful as a perioperative analgesic and antinociceptive adjuvant. Methods: The dose-dependent effects of adjuvant preoperative epidural tramadol on postoperative analgesia (pain scores and patient-controlled analgesia (PCA) use) and pain processing (heat pain thresholds) were prospectively studied in a doubleblind, randomised, placebo-controlled 5-day trial. Forty patients undergoing knee or hip surgery received anaesthesia with epidural lidocaine and epidural tramadol 20, 50 or 100 mg or placebo as a preoperative adjuvant. Postoperative analgesia was by intravenous PCA tramadol in all patients. Results: Postoperative pain scores were similar in all groups. The time to first PCA use was shorter, the total dose and duration of PCA use greater, and side-effects more common with 20 mg tramadol than with 100 mg or placebo (W0.05). There were no differences in PCA doses required or side-effects be-tween the tramado1100 mg and placebo treatment groups. Heat pain tolerance thresholds were increased with 100 mg tramadol at 48 h postoperatively compared to baseline and placebo (P= Conclusions: Preoperative adjuvant epidural tramadol does not improve postoperative analgesia after lidocaine epidural anaesthesia compared to placebo. Tramado120 mg results in anti-analgesia and increased side-effects. While tramadol 100 mg depresses postoperative pain-processing, as measured by heat pain tolerance thresholds, this is not reflected in improved clinical pain measures. 0.01).
Anesthesia Progress
This article details a double-blind, randomized, placebo-controlled pilot study evaluating the analgesic efficacy and clinical acceptability of intravenous tramadol in patients undergoing surgical removal of an impacted third molar tooth under local anesthesia and intravenous sedation with propofol. Forty-five ASA status 1 dental outpatients were randomly allocated to 2 groups of 22 (group A) and 23 (group B) patients each (n = 45). Group A (T/P) received intravenous tramadol 1.5 mg/kg injected over 2 minutes, followed by a bolus dose of intravenous propofol 0.4 mg/ kg. Maintenance consisted of a continuous infusion of propofol 3 mg/kg/h, with an additional bolus dose of 0.4 mg/kg intravenously 2-3 minutes prior to the infiltration of the local anesthetic solution. Group B (P/P) patients received no tramadol but instead a saline placebo solution and an identical amount of propofol. Overall, in this study, postoperative pain was much better controlled in the group receiving tramadol 1.5 mg/kg intravenously despite there being no significant difference in the dose of propofol administered in both groups. Intravenous tramadol, when given with propofol, did not affect the cardiovascular, respiratory, and sedative effects of propofol. Following tramadol, despite being an opioid, no nausea and vomiting were reported in the early postoperative period, indicating the value of using tramadol with propofol. Thus, this pilot study demonstrated the potential use of intravenous tramadol with propofol in day-case dento-alveolar surgery.
Review of extended-release formulations of Tramadol
2014
Abstract: Patients with chronic non-malignant pain report impairments of physical, social, and psychological well-being. The goal of pain management should include reducing pain and improving quality of life. Read this review and sign up to receive Journal of Pain Research here: http://www.dovepress.com/articles.php?article\_id=16193