ANZCTR search results

Control of moderate to severe pain in children following limb injury is a significant challenge in the emergency department. Intranasal administration of fentanyl is commonly used to reduce pain in this group. Ketamine, is a commonly used drug for procedural sedation in the ED. It has recently been shown to also provide good analgesia in doses that do not produce sedation and can also be administered intranasally (IN). An observational dose-confirmation, first time in ED, study was recently undertaken in the paediatric emergency department of Monash Medical Centre revealing that IN ketamine provided pain relief comparable to that reported in observational studies where IN fentanyl was used in children with limb injuries. The observationa study suggests that IN ketamine may be an alterantive pain reliver in children with moderate to severe pain. However, neither ketamine or fentanyl have been assessed in a blinded fashion in treating pain in children. We aim to compare the effectiveness, side effects and satisfaction of IN ketamine to IN fentanyl in a randomised controlled double-blind fashion in children presenting to the ED with moderate to severe pain and limb injuries. The results of this study will help confirm the effectiveness of both pain relievers and ascertain whether IN ketamine can be used in place of fentanyl in this patient group.

Continuous positive airways pressure (CPAP) is the treatment of choice for patients who have obstructive sleep apnoea (OSA). The patient wears an interface attached to a pump which delivers pressurized air to the upper airway, thereby splinting the airway open. The interface is usually one of three types, nasal pillows which sit directly in the nostrils, a nasal mask which covers the nose or a full-face mask which covers the nose and mouth. The nasal pillows and nasal mask require the patient to keep their mouth closed during treatment as opening the mouth releases pressure and this mouth leak results in less air pressure in the upper airway where it is required to splint the airway. The full-face mask ensures the nose and mouth are both in the pressurised area and thus prevents mouth leak from being a problem. Although the difference in dead space between the interfaces has been examined, the effect of the mechanical pressure from the headgear on the position of the lower jaw which is required to seal the full-face mask has not been clearly assessed. The force applied to the headgear to seal the full-face mask may result in the lower jaw being pushed back and thus the diameter of the upper airway being reduced. If this occurs, a higher CPAP pressure would be required to splint the airway. An alternative treatment for OSA is the mandibular advancement splint which relies on a dental device to pull the jaw forward to enlarge the airway opening. It is not unreasonable to presume that pressure in the reverse direction would have the opposite effect. This study aims to assess the pressure requirements of nasal versus full-face mask in patients with OSA by using auto-titrating continuous positive airways pressure (APAP).The APAP devices sense flow limitation and snore and respond to these by increasing or decreasing the positive airways pressure as required. The downloaded data can be examined to assess the pressure requirements of the patient. Patients will be assessed in a random order, crossover study comprising a two week period each of a suitably fitted nasal interface and a suitably fitted full-face interface. As the data will be collected over a two week period, night to night variation should be minimised. The APAP will assess the pressure requirements for each period to examine if there is any difference in pressure requirements between the two interfaces. The Mallampati score and pharyngeal dimensions will also be evaluated to examine if this is a possible pre-disposing factor.

This study aims to determine the efficacy of Adalimumab for active hand osteoarthritis. Primary hypothesis is Adalimumab will be superior to placebo for pain at 3 months in osteoarthritis of the hand. The design is a randomised, double blind, placebo controlled, crossover trial. Subjects will be randomised to Adalimumab/placebo followed by a 60 day washout and then the converse Adalimumab/placebo.

Identifying alcohol misuse early and delivering simple advice can be effective in moderating people’s drinking patterns and related harms such as injury. The evidence indicates that for every eight people who receive advice, one will reduce their drinking to low risk levels. The internet is becoming an increasingly recognised tool for delivering self-help materials. The project seeks to evaluate change in alcohol use and injury (self-reported) after participation in an internet delivered program compared with an information only control condition.

This study compares the complementary therapy of Healing Touch to a mimic healing touch treatment (a placebo) to determine if Healing Touch can assist older women who are living on their own in the community to remain functionally independent.

Allergies have been on the rise in Australia, and evidence suggests vitamin D may play a role. Vitamin D has been shown to influence the immune system and has been linked to asthma, eczema and food allergies. This study will help determine whether vitamin D supplements given to infants will alter the risk of development of allergic disease.

The primary purpose of the study is to compare the effects of brief vesus extended feedback and advice in promoting cannabis help/information seeking and assisting individiuals to reduce their cannabis use. Hypotheses: Relative to individuals who receive brief feedback, individuals who receive extended feedback will report (a) more information-seeking and help-seeking, (b) greater reductions in past-month cannabis use, (c) greater reductions in past-month cannabis dependence symptoms, (d) greater reductions in past-month cannabis abuse symptoms, and (e) greater satisfaction with the screening/feedback program.

The goal of this study is to investigate the efficacy of Bacopa as an adjunctive therapy to existing pharmaceutical treatments for Alzheimers patients. The study will test individuals diagnosed with mild to moderate Alzheimer's Disease, in a double blind, placebo controlled, parallel groups design. Particpants will either take Bacopa monniera for 90 days or a placebo for 90 days. Participants will attend an initial pre-screening and pratice session, baseline session and one follow-up testing session following 90 days of supplementation. During these session, participants will be required to complete several cognitive tests, which have been widely used to assess both enhancement and impairment of human cognitive performance. Mood and quality of life will also be assessed. It is hypothesised that measures of attention, processing speed and memory will improve in the Bacopa group relative to the placebo group. A further aim of the study is to investigate differences in mood and quality of life in the Bacopa treatment group relative to placebo.

The purpose of this study is to compare two proven skin care products (creams) in the context of patients undergoing radiation therapy for breast cancer in the tropics. Who is it for? you may be eligible to join this study if you are aged 18 years or older and are undergoing radiation treatment at the Radiation Oncology Unit, The Townsville Hospital, for cancer of the breast. Trial details Participants in this trial will be randomly (by chance) allocated to one of two groups. Participants in one group will apply CavilonTM Durable Barrier Cream twice per day to the radiation therapy treatment area from the first day of treatment up until 4 weeks following the end of the radiation therapy. Participants in the other group will use 100% Pure Sorbolene cream instead. Participants will be assessed weekly during treatment and at one month post treatment in order to identify if one cream is more effective than the other at preventing skin reactions associated with radiation therapy for breast cancer.

Surgical decompression of the lumbar canal in patients with significant symptoms of claudication or radicular pain and a radiological diagnosis of canal stenosis is both efficacious and well tolerated, with sustained long term benefits. Historically, lumbar canal stenosis was treated with complete laminectomy but recognition that the pathology is largely at the level of the disc and interlaminar space has led to less destructive approaches such as interlaminar decompression or laminotomy. Despite this, all published series report some morbidity and complications from surgery in what is typically an elderly population, such as dural tear, infection, persistent back pain and the need for blood transfusion or further surgical intervention. One concern is that of post-operative spondylolisthesis, which is thought to occur from disruption of the spinous processes and interspinous ligament, observed in up to 30% in some series. Minimally invasive techniques for decompression of the lumbar canal using a micro-endoscopic approach have been described and are growing in popularity. Instead of a midline posterior approach to the spinal canal, where the muscles are dissected bilaterally and the posterior spinal structures removed, a minimally invasive technique uses a unilateral, paramedian approach where the muscles are preserved and surgery is carried out through an 18mm diameter working tube. The surgical field is illuminated and magnified under the operating microscope and custom designed bayoneted instruments are employed to avoid obscuring vision. The spinal canal is decompressed in the same way as one would using an open approach but the posterior spinal structures are largely preserved, which offers a biomechanical advantage with the potential to reduce late spondylolisthesis. The less destructive approach should also reduce early post-operative back pain, promote more rapid mobilisation, and consequently reduce the number of inpatient hospital days. There is a growing body of evidence supporting the efficacy of this technique for treating patients with lumbar canal stenosis though there are concerns over the adequacy of decompression through a small operating tube and the learning curve associated with the adoption of this less invasive but potentially more restricted technique. Thus far, a number of observational studies have implied early advantages to patients offered minimally invasive over open lumbar canal decompression, there has yet to be a properly conducted and appropriately powered randomised controlled trial to confirm that the techniques are similarly effective in terms of medium to long-term functional outcome. A phase III non-inferiority trial design, i.e., to show that minimally invasive lumbar canal decompression is not inferior to standard open lumbar decompression, is considered to be the most stringent and statistically appropriate trial design to answer this important question. Trial participants will be recruited from patients undergoing elective open or minimally invasive decompressive lumbar laminectomy for degenerative lumbar canal stenosis at the Mater Misericordiae Private Hospital. After obtaining consent for the patients’ participation in the trial, they will undergo pre-operative clinical and radiological assessment by their consultant surgeon, including MRI and X-ray lumbar spine, in the usual way. Baseline questionnaires will be obtained pre-operatively. After randomisation to either surgical arm, open or minimally invasive lumbar decompression surgery will proceed in the usual way. There will be no changes to the usual surgical management of the patient resulting from the trial. Post operative management will proceed in the usual way, with no changes to normal post operative surgical management. Patients will complete outcome questionnaires prior to discharge. Patients will be assessed for discharge by a physiotherapist and their surgeon, and discharged at a clinically appropriate time in the usual way. Patients will be followed up at their routine appointment with the consultant surgeon. Outcome questionnaires will be completed at periods up to 24 months post operatively, and a follow up X-ray and MRI lumbar spine will be obtained. Data obtained will allow comparison of the outcomes of the two surgical procedures, including patient outcome measures, morbidity and adverse events, and radiological outcomes including extent of decompression and development of late spondylolisthesis.