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Double-blinded Trial (double-blinded + trial)
Selected AbstractsAnalgesic efficacy of local anaesthetic wound administration in knee arthroplasty: volume vs concentrationANAESTHESIA, Issue 10 2010L. Ø. Andersen Summary Wound administration of local anaesthetic may be effective for postoperative pain management in knee arthroplasty, but the analgesic efficacy of local anaesthetic in relation to volume vs concentration has not been determined. In a double-blinded trial, 48 patients scheduled for total knee arthroplasty were randomly assigned to receive either a high volume/low concentration solution of ropivacaine (20 ml, 0.5%) or a low volume/high concentration solution of ropivacaine (10 ml, 1%), 6 and 24 h postoperatively through an intracapsular catheter. Pain was assessed for 2 h after administration. Pain was reduced in both groups with ropivacaine administration 24 h postoperatively (p < 0.02), but with no difference in analgesia between groups at all time intervals. No reduction in pain scores was observed with ropivacaine injection 6 h postoperatively. The median (IQR [range]) dose of oxycodone administered was 12.5 (10,19 [0,35]) mg in the high volume/low concentration group, and 20 mg (16,40 [0,65]) mg in the low volume/high concentration group (p = 0.005). In conclusion, intracapsular administration of local anaesthetic may have limited analgesic efficacy with no volume vs concentration relationship after total knee arthroplasty. [source] Effect of ondansetron pretreatment on pain after rocuronium and propofol injection: a randomised, double-blind controlled comparison with lidocaineANAESTHESIA, Issue 9 2001M. S. Reddy In a randomised, controlled, double-blinded trial to study the effect of ondansetron pretreatment on the pain produced after intravenous injection of rocuronium and propofol in comparison with lidocaine, 60 patients were randomly assigned to one of three groups. Group 1 received 5 ml of intravenous 0.9% sodium chloride solution pretreatment, group 2 received ondansetron 4 mg (2 mg.ml,1 solution) diluted into a 5-ml solution, and group 3 received 50 mg lidocaine (5 ml 1% solution); this was followed 1 min later by rocuronium and propofol. Pain was reduced significantly in the ondansetron and lidocaine groups (p < 0.0001) compared with placebo, and significantly better with lidocaine than with ondansetron (p = 0.02). We conclude that ondansetron is effective in relieving the pain of rocuronium but is not as effective as lidocaine. [source] Vascular endothelial growth factor gene transfer for diabetic polyneuropathy: A randomized, double-blinded trial,ANNALS OF NEUROLOGY, Issue 4 2009Allan H. Ropper MD Objective Randomized, blinded trial of intramuscular gene transfer using plasmid vascular endothelial growth factor (VEGF) to treat diabetic polyneuropathy. Methods Diabetic patients with polyneuropathy were randomized to receive a VEGF-to-placebo ratio of 3:1. Three sets of injections were given at eight standardized sites adjacent to the sciatic, peroneal, and tibial nerves of one leg. Primary outcomes were change in symptom score at 6 months and a prespecified overall clinical and electrophysiological improvement score. Secondary outcomes were differences in symptoms, examination scores, visual analog pain scale, nerve conduction, and quantitative sensory testing. Results Thirty-nine patients received plasmid VEGF and 11 received placebo. Mean symptom score improved in both legs at 6 months, favoring VEGF over placebo (,1.2 ± 0.5 vs ,0.9 ± 0.5; p < 0.01 after adjustment for change in the untreated leg) and compared with the untreated leg (,0.7 ± 0.5; p = 0.02). The region of sensory loss and visual analog pain scale improved in the treated group (,1.5 vs ,0.5; p = 0.01). Twelve of 39 VEGF versus 2 of 11 placebo patients met criterion for overall improvement. Other measures including nerve conduction potentials did not improve. There were 84 adverse events in VEGF patients, and 22 were serious; there were 51 events in placebo patients, and 2 were serious. Interpretation Intramuscular plasmid VEGF gene transfer improved diabetic neuropathic symptoms, meeting primary end-point criteria for efficacy but not affecting most secondary measures. Treatment was associated with more serious adverse events that did not reach statistical significance. These results are not conclusive but may justify further clinical study. Ann Neurol 2009;65:386,393 [source] World Health Organisation multicentre randomised trial of supplementation with vitamins C and E among pregnant women at high risk for pre-eclampsia in populations of low nutritional status from developing countriesBJOG : AN INTERNATIONAL JOURNAL OF OBSTETRICS & GYNAECOLOGY, Issue 6 2009J Villar Objective, To determine if vitamin C and E supplementation in high-risk pregnant women with low nutritional status reduces pre-eclampsia. Design, Multicentred, randomised, controlled, double-blinded trial. Setting, Antenatal care clinics and Hospitals in four countries. Population, Pregnant women between 14 and 22 weeks' gestation. Method, Randomised women received 1000 mg vitamin C and 400 iu of vitamin E or placebo daily until delivery. Main outcome measures, Pre-eclampsia, low birthweight, small for gestational age and perinatal death. Results, Six hundred and eighty-seven women were randomised to the vitamin group and 678 to the placebo group. Groups had similar gestational ages (18.1; SD 2.4 weeks), socio-economic, clinical and demographical characteristics and blood pressure at trial entry. Risk factors for eligibility were similar, except for multiple pregnancies: placebo group (14.7%), vitamins group (11.8%). Previous pre-eclampsia, or its complications, was the most common risk factor at entry (vitamins 41.6%, placebo 41.3%). Treatment compliance was 87% in the two groups and loss to follow-up was low (vitamins 2.0%, placebo 1.3%). Supplementation was not associated with a reduction of pre-eclampsia (RR: 1.0; 95% CI: 0.9,1.3), eclampsia (RR: 1.5; 95% CI: 0.3,8.9), gestational hypertension (RR: 1.2; 95% CI: 0.9,1.7), nor any other maternal outcome. Low birthweight (RR: 0.9; 95% CI: 0.8,1.1), small for gestational age (RR: 0.9; 95% CI: 0.8,1.1) and perinatal deaths (RR: 0.8; 95% CI: 0.6,1.2) were also unaffected. Conclusion, Vitamins C and E at the doses used did not prevent pre-eclampsia in these high-risk women. [source] Tetracycline to prevent epidermal growth factor receptor inhibitor-induced skin rashes,CANCER, Issue 4 2008Results of a placebo-controlled trial from the North Central Cancer Treatment Group (N03CB) Abstract BACKGROUND. Epidermal growth factor receptor (EGFR) inhibitors are effective cancer therapies, but they are reported to cause a rash in >50% of patients. In the current study, the authors examined the use of tetracycline for rash prevention. METHODS. This placebo-controlled, double-blinded trial enrolled patients who were starting cancer treatment with an EGFR inhibitor. Patients could not have had a rash at the time of enrollment. All patients were randomly assigned to receive either tetracycline at a dose of 500 mg orally twice a day for 28 days versus a placebo. Patients were monitored for rash (through monthly physician assessment and weekly patient-reported questionnaires), quality of life (using the SKINDEX-16, a skin-specific quality of life index), and adverse events. Monitoring occurred during the 4-week intervention and then for an additional 4 weeks. The primary objective of the current study was to compare the incidence of rash between the study arms, and the enrollment of 30 patients per arm provided a 90% probability of detecting a 40% difference in incidence with a P value of .05 (2-sided). RESULTS. A total of 61 evaluable patients were enrolled. The 2 treatment arms were well balanced with regard to baseline characteristics, dropout rates, and rates of discontinuation of the EGFR inhibitor. The incidence of rash was found to be comparable across treatment arms. Physicians reported that 16 patients treated with tetracycline (70%) and 22 patients treated with placebo (76%) developed a rash (P = .61). Tetracycline appears to have lessened the rash severity, although the high dropout rates invite caution when interpreting these findings. By Week 4, physician-reported grade 2 rash (using the National Cancer Institute's Common Terminology Criteria for Adverse Events [version 3.0]) occurred in 17% of tetracycline-treated patients (n = 4 patients) and in 55% of placebo-exposed patients (n = 16 patients) (P = .04). Patients treated with tetracycline reported better scores, as per the SKINDEX-16, on certain quality-of-life parameters such as skin burning or stinging, skin irritation, and being bothered by the persistence/recurrence of a skin condition. Adverse events were found to be comparable across treatment arms. CONCLUSIONS. In the current study, tetracycline was not found to prevent EGFR inhibitor-induced rashes and therefore cannot be clinically recommended for this purpose. However, preliminary observations of diminished rash severity and improved quality of life suggest this antibiotic merits further study. Cancer 2008. © 2008 American Cancer Society. [source] | ||||||||||