Patient reporting of potential adverse drug reactions: a methodological study.

AIMS: To develop a systematic generic method of enabling patients to report symptoms which they believe to be due to a particular prescribed drug. METHODS: A piloted body system-based questionnaire was distributed to patients registered with 79 medical practices in Grampian prescribed one of nine recently marketed 'black triangle' drugs. These comprised four antidepressants, three antiepileptics and two analgesics. This requested respondents to identify any symptoms experienced over the previous year which they thought could be due to the 'black triangle' drug they had used. A sample of medical records was examined to compare symptoms recorded with those reported by patients. A classification system was developed for the study to enable the assessment of symptoms reported for their potential relationship to patients' drug therapy. All symptoms reported were classified, taking into account information provided by patients on their concomitant drugs and diseases. A specialist pharmacist independently re-classified a sample of the symptoms to validate the process. RESULTS: A 36.3% response rate was obtained (837/2307) with 742 respondents (88.6%) reporting at least one symptom. The median per patient was 6.0 (range 0--71), with almost half (406, 48.5%) reporting fewer than five symptoms. Most symptoms (71.0%) were classified as being probably or possibly related to the drugs studied. Agreement between researcher and specialist on the classification of 75.3% of 716 symptoms was obtained (Kappa=0.563). Responses from patients prescribed antidepressant drugs were more likely to include symptoms potentially caused by these drugs (74.5% of all symptoms reported) than those from patients prescribed analgesics (67.4%) or antiepileptics (65.1%, chi2 = 23.858, d.f. = 2, P < 0.001). Patients reporting large numbers of symptoms were more likely to report some which were classed as unlikely to be an ADR or unattributable (chi2 = 80.587, d.f. = 3, P < 0.001). Of the 742 reporting symptoms in questionnaires, 402 (54.2%) claimed to have reported some or all of these to their doctor. Only 162 (22.6%) of 716 patient-reported symptoms were documented in the primary care medical records of 103 patients prescribed Tramadol ( Generic Ultram ) or venlafaxine. CONCLUSIONS: Respondents were clearly willing to report symptoms, the majority of which were classed as possibly/probably related to the drugs studied. The results suggest that patients do not report all symptoms they suspect to be ADRs to their GP and that GPs do not record all symptoms which may be reported to them. The method could help to identify problems which patients perceive as being related to their drug therapy and contribute to increased ADR reporting.

Effect of Tramadol ( Generic Ultram ) on provoked potentials of dental pulp

The central-acting analgetic (Tramadol ( Generic Ultram ) 50 mg) demonstrated significant effects on wave latencies of provoked potentials in females. However, the same doze had no significant effect on wave latencies of provoked potentials in males. Tramadol ( Generic Ultram ) provoked a statistically significant reduction of all wave amplitudes of provoked potentials of dental pulp in both sexes. Thus, provoked potentials recorded under this condition gave an "objective" index of Tramadol ( Generic Ultram ) analgetic effects.

Advanced fibre optical scanning in thin-layer chromatography for drug identification.

Two simple and sensitive kinetic methods for the determination of Tramadol ( Generic Ultram ) hydrochloride are described. The first method is based upon a kinetic investigation of the oxidation reaction of the drug with alkaline potassium permanganate at room temperature for a fixed time at 20 min. The absorbance of the colored manganate ions was measured at 610 nm. The second method is based on the reaction of Tramadol ( Generic Ultram ) hydrochloride with 4-chloro-7-nitrobenzofurazan (NBD-Cl) in presence of 0.1 M sodium bicarbonate. The spectrophotometric measurements were recorded by measuring the absorbance at 467 nm, at fixed time at 25 min on thermostated water bath at 90+/-1 degrees C. All variables affecting the development of the colour have been investigated and the conditions were optimised. The absorbance concentration plots in both methods were rectilinear over the range 5-25 and 50-250 microg ml(-1), for the first and second methods, respectively. The two methods have been applied successfully to commercial capsule and ampoule dosage form. The results obtained are compared statistically with those given by the reference spectrophotometric method. The determination of Tramadol ( Generic Ultram ) hydrochloride by the fixed concentration and rate constant methods is feasible with the calibration equations obtained, but the fixed time method proves to be more applicable.

Results of a survey of anesthetists on postoperative nausea and vomiting

OBJECTIVE: Although an increasing number of studies concerning postoperative nausea and vomiting (PONV) have been performed, we do not know, what anaesthesiologists think about this problem and how they handle it in their daily routine. METHODS: A survey was performed involving anesthesiologists at 30 institutions of different size. 474 out of 1000 questionnaires were returned. RESULTS: When asked what kind of general anaesthesia they prefere in a woman at a very high risk to suffer PONV, the following answers were obtained: anaesthesia induction with propofol (78%), thiopentone (17%), etomidate (5%). Maintenance of anaesthesia with an inhalation anesthetic (44%) or with propofol (44%). The remaining 14% would use a combination of these techniques (6%) or neuroleptanaesthesia with droperidol (5%) or midazolam (1%). Only 10% of the respondants would omit nitrous oxide. There is no consensus about the optimal amount of intraoperative opioids. Fentanyl, alfentanil, and sufentanil are rated to contribute equally to the occurence of PONV, whereas opioids used for postoperative analgesia are thought to have substantial differences: piritramid is rated to be much less emetogenic than Tramadol ( Generic Ultram ) and morphine. 70% advocate routine antiemetic prophylaxis for high-risk patients (most often mentioned risk factors were: female sex: 85%, obesity: 81%, high doses of intraoperative opioids: 72%) and 23% administrate antiemetics even for all patients. Ondansetron and droperidol are suggested to be superior to metoclopramide, triflupromazine, dimenhydrinate, and transdermal scopolamine. However, metoclopramide is the drug of first choice for more than 50% of the respondants followed by droperidol, whereas only 29% use ondansetron as a first line drug. An unexpected high number of anaesthesiologists (13%) have experience with non-pharmacological methods for prophylaxis and treatment of PONV. Acupuncture/acupressure (10%) was most often mentioned. CONCLUSION: A great majority (93%) stated, that PONV is a relevant problem, that still remains unsolved. This proofs the need for further controlled studies.

Immediate postoperative pain management in patients undergoing major abdominal surgery after remifentanil-based anesthesia: sufentanil vs Tramadol ( Generic Ultram ).Cafiero T, Di Minno RM, Sivolella G, Di Iorio C.Department of Anesthesia, Postoperative Intensive Care, Burn Center and Hyperbaric Center A. Cardarelli Hospital, Naples, Italy. AIM: The transition from intraoperative analgesia to postoperative analgesia must be planned carefully after remifentanil-based anesthesia, due to the short duration of action of remifentanil. The aim of this study is to compare the efficacy and safety of 2 transition strategies using sufentanil or Tramadol ( Generic Ultram ) for early postoperative pain relief in patients who had major abdominal surgery under general anesthesia with remifentanil/sevoflurane. METHODS: Sixty patients participated in this double-blind, prospective study and were randomly assigned to either sufentanil (S) group or Tramadol ( Generic Ultram ) (T) group. Twenty minutes before the end of surgery the patients received either a bolus of 0.15 microg kg(-1) sufentanil (group S) or Tramadol ( Generic Ultram ) 100 mg (group T). Mean arterial pressure (MAP), heart rate (HR) and rate pressure product (RPP=systolic arterial pressure (SAP)xHR), analgesia by a verbal rating score (VRS) and sedation by a sedation score (SS) were evaluated at emergence from anesthesia. RESULTS: A statistically significant difference in HR between the 2 groups was recorded at extubation (78+/-13 in group S vs 86+/-24 in group T). A significant decrease of RPP values at extubation and 5 minutes later were found in group S in comparison with group T. VRS values were significantly lower in sufentanil group at 5 and 10 minutes after awakening. CONCLUSIONS: Sufentanil provided more effective transition analgesia in comparison with Tramadol ( Generic Ultram ). The effects of remifentanil dissipated rapidly and analgesia with major opioids was required. A bolus dose of sufentanil 0.15 microg kg(-1) was efficacious in controlling the hemodynamic parameters at awakening from anesthesia. The lower HR values and, consequently the lower RPP values are of utmost importance especially in the aged cardiovascular risk patient.

Lornoxicam, a new potent NSAID with an improved tolerability profile.

Lornoxicam is a member of the oxicam group of nonsteroidal antiinflammatory drugs (NSAIDs). Oxicams have potent antiinflammatory and analgesic effects, but their use is associated with a high risk of gastrointestinal adverse effects. Lornoxicam has been shown to be at least as effective as comparative NSAIDs and more effective than 10 mg morphine when used at doses > or = 8 mg to control pain after oral surgery. In addition, oral doses of lornoxicam of 16-24 mg daily have been more effective than Tramadol ( Generic Ultram ) 300 mg daily in pain following knee surgery. Lornoxicam combines the high therapeutic potency of oxicams with an improved gastrointestinal toxicity profile as compared to naproxen, for example. This is probably due to the short half-life of lornoxicam as compared to the other oxicams. The clinical trials published so far, mostly comparative, clearly do- cument the efficacy of lornoxicam as a potent analgesic with excellent antiinflammatory properties in a range of painful and/or inflammatory conditions, including postoperative pain and rheumatoid arthritis.