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Fentanyl is a morphine-like pain relieving drug used for pain relief after caesarean section. In our institution most patients have "patient-controlled epidural analgesia" (PCEA) following routine or emergency caesarean section. PCEA allows the patient to give themselves small doses of drug safely by pressing a button on a pump whenever the pain is more than they find acceptable. However, not all women are suitable for an epidural. In some other cases, the epidural is removed straight after the operation because of concern about infection or bleeding risks, sometimes the epidural catheter falls out early on. Pain relief in these cases is usually provided with oral medications and/or an intravenous patient controlled analgesia pump (PCIA). Recently a patient-controlled analgesia pump has been made that allows a patient to give themselves a pain relieving drug, for example fentanyl, as a nasal spray; this method is called "patient-controlled intranasal analgesia" or PCNA. The aim of this study is to compare PCEA and PCNA, to see whether PCNA could be a reliable alternative method of pain relief after caesarean section. This study will compare two methods of pain relief after caesarean section. Patients will, over two consecutive 18 hour time periods, self-administer epidural fentanyl for one period and intranasal fentanyl for the other. The order in which the fentanyl is used will be randomised (i.e. based on a toss of a coin), so each patient may receive either epidural or nasal fentanyl first. After 18 hours, this will changed around. However, to "blind" the study (a means of making sure the results are more reliable), patients will be given both an epidural and a nasal patient controlled analgesia pump; they will be asked to press both each time they need some more medication; and they will not be told which one contains fentanyl (the other will contain saline solution, a "placebo". This means patients will be unaware as to whether the fentanyl is being given into the epidural or the nose. At regular intervals during the 36 hours of the study, patients will be asked about pain relief, side effects (for example, feeling sick or drowsy), recovery from the operation and satisfaction. Patients will also receive regular paracetamol tablets for pain relief, and other tablet pain relief is available if required. In all other respects, patients will be looked after routinely. Because we also want to know what the blood levels of fentanyl are, we need to take a series of small blood samples at 8 times during the 36 hours of the study period. The age, weight and general well-being of the baby will also be assessed. This will include a painless clinical examination of the baby's alertness. The entire examination should not take more than 10 minutes and will be performed by a paediatrician or anaesthetic research doctor. This will take place at the end of the first study period (at about 18 hours after operation).

A large multinational, double-blind, randomized Phase III clinical study designed to compare the efficacy and safety of telavancin (10mg/kg IV once daily) versus vancomycin (1gm IV q12 hr) in adult patients with complicated skin and skin structure infections (cSSSI) caused by Gram-positive bacteria. The primary objective of the study was to compare the efficacy and safety of telavancin to vancomycin in the treatment of adults with complicated Gram positive skin and skin structure infections with an emphasis on patients with infections due to methicillin resistant Staphylococcus aureus (MRSA). A key secondary objective of this study was to pool the data from this study with data from a second study of identical design (Study 0018) and to assess the superiority of telavancin to vancomycin in patients with MRSA infections. Patients were assessed for clinical response by assessing a patient’s signs and symptoms at the specified evaluation compared to their Baseline evaluation. A cure consisted of resolution of signs and symptoms associated with the skin infection present at study admission such that no further antibiotic therapy was necessary. Not cured meant there was an inadequate response to study therapy and Indeterminate meant the outcome was not able to be determined.

This clinical research study was completed in 2009.

BACKGROUND: HMG Co-A reductase inhibitors are ubiquitous in our community yet their potential role in age-related macular degeneration (AMD) remains to be determined. METHODOLOGY/PRINCIPAL FINDINGS: OBJECTIVES: To evaluate the effect of simvastatin on AMD progression and the effect modification by polymorphism in apolipoprotein E (ApoE) and complement factor H (CFH) genes. DESIGN: A proof of concept double-masked randomized controlled study. PARTICIPANTS: 114 participants aged 53 to 91 years, with either bilateral intermediate AMD or unilateral non-advanced AMD (with advanced AMD in fellow eye), BCVA = 20/60 in at least one eye, and a normal lipid profile. INTERVENTION: Simvastatin 40 mg/day or placebo, allocated 1:1. MAIN OUTCOME MEASURES: Progression of AMD either to advanced AMD or in severity of non-advanced AMD. Results. The cumulative AMD progression rates were 70% in the placebo and 54% in the simvastatin group. Intent to treat multivariable logistic regression analysis, adjusted for age, sex, smoking and baseline AMD severity, showed a significant 2-fold decrease in the risk of progression in the simvastatin group: OR 0.43 (0.18-0.99), p = 0.047. Post-hoc analysis stratified by baseline AMD severity showed no benefit from treatment in those who had advanced AMD in the fellow eye before enrolment: OR 0.97 (0.27-3.52), p = 0.96, after adjusting for age, sex and smoking. However, there was a significant reduction in the risk of progression in the bilateral intermediate AMD group compared to placebo [adjusted OR 0.23 (0.07-0.75), p = 0.015]. The most prominent effect was observed amongst those who had the CC (Y402H) at risk genotype of the CFH gene [OR 0.08 (0.02-0.45), p = 0.004]. No evidence of harm from simvastatin intervention was detected. CONCLUSION/SIGNIFICANCE: Simvastatin may slow progression of non-advanced AMD, especially for those with the at risk CFH genotype CC (Y402H). Further exploration of the potential use of statins for AMD, with emphasis on genetic subgroups, is warranted.

In this study we wish to work out what volume of blood, injected into the epidural area in an "epidural blood patch" best cures or helps treat headache caused by leak of spinal fluid. This leak occurs because a hole has been made in a membrane containing the spinal fluid, near the epidural space. An epidural blood patch is the only known way of stopping or effectively reducing headache of this type and is used worldwide to treat severe headaches of this type. It can fix the headache completely, but is often only partially effective. Many years ago the volume of blood used in an epidural blood patch was very small. Later the recommended volume was increased to about 15 ml, as this appeared to work better. Subsequently, larger volumes of blood, such as 20 ml, were recommended, while some anaesthetists now claim best results when even more is injected. There have not been any well controlled studies comparing different volumes of blood for epidural blood patch. Although larger volumes of blood are currently favoured, these may be associated with a higher incidence of mild or moderate low back pain during the injection and subsequent back soreness. A number of maternity units in Australasia and overseas will be involved in this study and the results will be of interest internationally. What does the study involve? The epidural blood patch will be performed in the usual way. Patients will be randomised to one of three groups, each group receiving a slightly different volume of blood (15 ml, 20 ml or the maximum volume up to 30 ml that can be injected without causing significant discomfort in the back). It is usually easy to inject 15 or 20 ml without causing significant back discomfort and the volumes chosen are all ones commonly used by maternity units around the world. In addition, to make sure the most accurate results are obtained, neither the patient or the staff asking questions about well-being after the epidural blood patch will know which group the patient was in. Patients will be asked questions about the severity and characteristics of the headache both before and at regular intervals after the epidural blood patch (at 2, 4, 24, 48, 72 hours and 5 days, by telephone if the patient has left hospital). Patients will also be asked about back discomfort experienced during and after the procedure, and whether they noticed any effects other than relief of the headache. As is usual practice, patients will be rested flat in bed for 2 hours after the epidural blood patch and then be allowed to get up, according to the usual practice in the hospital. If the patient does not get complete relief of the headache or suffers a return of headache later, they will be able to use a variety of drugs to try and get some relief. Also, if necessary, another blood patch could be performed, once more than 48 hours has passed from the first epidural blood patch. We will not know whether any particular volume is more effective than another. With an epidural blood patch, a common effect is mild back discomfort during injection and for a variable time after the blood patch, lasting up to a few days. If the patient experiences significant back pain during the injection, the injection will be stopped according to usual practice, irrespective of whether they have received the amount for their group. Usually back pain during injection is mild and easy to handle. Most women describe back stiffness rather than pain after the epidural blood patch. It has been suggested that injection of the largest volume of blood may be more effective but also cause more back discomfort, but this has not been confirmed by proper study. There are some very rare serious complications of epidural blood patch, such as infection, severe back pain and blood clots around the brain, but there is no suggestion that taking part in the study is likely to affect the risk of these in any way.