Manuel Rodríguez

Efficacy and safety of dipyrone versus tramadol in the management of pain after hysterectomy: A randomized, double-blind, multicenter study

Background and Objectives We assessed the efficacy and safety of dipyrone in comparison with tramadol in the relief of early postoperative pain following abdominal hysterectomy. Methods A total of 151 women between 18 and 60 years of age undergoing abdominal hysterectomy during general anesthesia participated in a randomized, double-blind, controlled, multicenter study. Seventy-three patients received dipyrone and 78 received tramadol. Patients received an intravenous loading dose of the study drug immediately after operation followed by intravenous (IV) maintenance infusion and IV on-demand boluses up to a maximum number of predetermined doses/day of 8 g dipyrone and 500 mg tramadol. The duration of the study was 24 hours. Results The mean (SD) number of boluses in the dipyrone group was 3.8 (2.4) and 3.5 (2.5) in the tramadol group (95% confidence interval, −0.455 to 1.175), and the percentage of patients requiring rescue IV morphine (dipyrone 26.9%, tramadol 26.8%) was not statistically significant. Other analgesic efficacy parameters, such as pain intensity differences, sum of pain intensity differences, pain relief assessed by the patient, or patients who required the maximum number of demand doses, were not different between treatment groups. A significantly higher percentage of adverse gastrointestinal effects was found in patients given tramadol (42.1%) than in patients given dipyrone (20.2%) (P < .05). Also, a significantly higher number of tramadol-treated patients required ondansetron to control nausea and vomiting at 1 hour (19% v 7%), 2 hours (26% v 11%), and 24 hours (46% v 29%) (P < .05) after surgery. Patients and the investigators reported similar tolerability for both study arms. Conclusions Dipyrone and tramadol showed similar efficacy for early pain relief after abdominal hysterectomy. Nausea and vomiting, possibly caused by the tramadol, occurred more frequently in those patients. In this group, the need of the antiemetic drug ondansetron was also higher.

COMPARATIVE STUDY OF TRAMADOL VERSUS NSAIDS AS INTRAVENOUS CONTINUOUS INFUSION FOR MANAGING POSTOPERATIVE PAIN

Abstract We compared the analgesic efficacy and safety of tramadol, a new pure agonistic central analgesic, with that of three nonsteroidal anti-inflammatory drugs (NSAIDs) in the control of postoperative pain. A total of 160 patients undergoing abdominal hysterectomy participated in this randomized, double-blind study. Four treatment groups were established: tramadol, metamizole, ketorolac, and lysine clonixinate, with 40 patients in each group. Analgesics were administered using continuous infusion plus patient-controlled analgesia. During this 24-hour study, pain was assessed by using a visual analog scale. The number of boluses required per patient, the number of patients requiring supplementary analgesia, the presence of nausea or vomiting, the need for antiemetics, and an evaluation of overall efficacy also were recorded during the first 24 hours after surgery. The analgesic efficacy of tramadol was found to be greater than that of the three NSAIDs. Tramadol also was statistically significantly better than the other three agents with regard to the number of boluses required per patient (1.6 versus 4.4 for metamizole, 4.5 for ketorolac, and 5.3 for lysine clonixinate) and the number of patients requiring supplementary analgesia (1 patient versus 5 for metamizole, 11 for ketorolac, and 11 for lysine clonixinate). Nausea and vomiting were common in all four groups, especially in patients treated with metamizole, but the need for antiemetics was significantly lower with tramadol and lysine clonixinate. With regard to overall efficacy, as rated by the physician, excellent and very good results were obtained in 79.5% of the patients in the tramadol group, compared with 57.5%, 57.5%, and 50% of those in the metamizole, ketorolac, and lysine clonixinate groups, respectively ( P

Trends in the prevalence and distribution of HTLV-1 and HTLV-2 infections in Spain

BackgroundAlthough most HTLV infections in Spain have been found in native intravenous drug users carrying HTLV-2, the large immigration flows from Latin America and Sub-Saharan Africa in recent years may have changed the prevalence and distribution of HTLV-1 and HTLV-2 infections, and hypothetically open the opportunity for introducing HTLV-3 or HTLV-4 in Spain. To assess the current seroprevalence of HTLV infection in Spain a national multicenter, cross-sectional, study was conducted in June 2009.ResultsA total of 6,460 consecutive outpatients attending 16 hospitals were examined. Overall, 12% were immigrants, and their main origin was Latin America (4.9%), Africa (3.6%) and other European countries (2.8%). Nine individuals were seroreactive for HTLV antibodies (overall prevalence, 0.14%). Evidence of HTLV-1 infection was confirmed by Western blot in 4 subjects (prevalence 0.06%) while HTLV-2 infection was found in 5 (prevalence 0.08%). Infection with HTLV types 1, 2, 3 and 4 was discarded by Western blot and specific PCR assays in another two specimens initially reactive in the enzyme immunoassay. All but one HTLV-1 cases were Latin-Americans while all persons with HTLV-2 infection were native Spaniards.ConclusionsThe overall prevalence of HTLV infections in Spain remains low, with no evidence of HTLV-3 or HTLV-4 infections so far.

Double-blind evaluation of short-term analgesic efficacy of orally administered dexketoprofen trometamol and ketorolac in bone cancer pain

&NA; The analgesic efficacy and safety of dexketoprofen trometamol (the active enantiomer of the racemic compound ketoprofen) (25 mg q.i.d.) vs. ketorolac (10 mg 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.

Prevalence and Characterization of Breakthrough Pain Associated with Chronic Low Back Pain in the South of Spain: A Cross-Sectional, Multicenter, Observational Study

Chronic low back pain (CLBP) is highly prevalent in industrialized countries, where it is one of the main causes of disability. Patients with CLBP in treatment with opioids often experience episodes of breakthrough pain (BTP), but data on prevalence and treatment preferences are scarce. The objectives of this study were, first, the evaluation of the prevalence of BTP in patients with CLBP in the South of Spain (N = 1,868) and, second, the characterization of BTP in these patients (N = 295). Data was collected on presence of BTP, type and location of pain, treatment, compliance, and patient satisfaction. We found a prevalence of BTP in patients with CLBP of 37.5% (95% CI: 35.3%–39.7%), similar in men and women. 75% of the patients were older than 50 years. The preferred drug of patients who control BTP with opioids is fentanyl (78.3%) and its most common form of administration is nasal (53.2%). Therapeutic compliance was high and 46.3% of patients considered the control of their BTP very satisfactory. Our study showed that BTP is common in patients with CLBP and that current treatments seem adequate.

Evaluation of the quality of care of elderly patients with chronic and breakthrough pain treated with opioids: SAND study

Abstract Objective: The objective of this study was to evaluate the quality of care of elderly patients with treatment for chronic pain (CP) and breakthrough pain (BTP). Methods: A cross-sectional observational study was conducted in 20 pain units, selecting patients aged 70 years or older with baseline controlled CP in treatment with opioids and a diagnosis of BTP. Patients were classified as first episode of BTP or patient in follow-up. The patients completed the SF-12 quality of life questionnaire, Brief Pain Inventory, Lattinen Index, and Edmonton Symptoms Assessment Scale. The patient’s satisfaction with the treatment was evaluated through a visual analogue scale (VAS). Results: A total of 199 patients were included with 67.7% women (132). There were 28.5% (55) attending the first visit for BTP and 71.5% (138) were on follow-up visits. On the physical component of the SF-12, 95% had a score below the mean for the Spanish general population and 44% had a score below the mean on the mental component. Worse scores were observed for women in the bodily pain dimension (p = .032) and in the overall physical component (p = .045). There were 62.9% (112) patients satisfied with the treatment for BTP. In the multivariate analysis, SF-12 physical component scores (p = .017) and patient’s satisfaction with BTP treatment was better in follow-up visits (p = .031). Conclusions: All clinical parameters compared between first visit for the treatment of BTP and follow-up visits were improved, so the quality of care was also considered improved. Elderly women and non-oncologic patients were observed to be the population with worse symptom control.

Prevalence and changing distribution of HTLV-1 and HTLV-2 infections in Spain

Prevalence and changing distribution of HTLV-1 and HTLV-2 infections in Spain Ana Trevino, Antonio Aguilera, Estrella Caballero, Rafael Benito, Patricia Parra, Jose M Eiros, Araceli Hernandez, Enrique Calderon, Manuel Rodriguez, Alvaro Torres, Juan Garcia, Jose Manuel Ramos, Lourdes Roc, Goitzane Marcaida, Carmen Rodriguez, Matilde Trigo, Cesar Gomez, Raul Ortiz de Lejarazu, Carmen de Mendoza, Vincent Soriano