ANZCTR search results

Introduction: Pain is an adverse effect associated with vaccination. Ice may be used to reduce pain. This prospective randomised controlled trial aims to investigate the effect of applying an ice pack prior to immunisation on the outcome of pain in medical students receiving their flu vaccines. Methods and analysis: This double-blinded, multicentre, prospective randomised controlled trial is designed to investigate impact of ice packs in reducing injection-related pain in medical students receiving influenza vaccines. The study will include 90 patients who receive influenza vaccines. An ice pack (0°C) will be applied to the site of injection for 30 seconds in participants randomised to the intervention group (n = 45). A placebo cold pack (10°C) will be applied to those in the control group (n = 45) for the same duration immediately prior to vaccination. A standardised vaccination protocol will be used across both study arms. The primary objective is to test the hypothesis that applying an ice pack will significantly reduce pain in comparison to a cold pack. Secondary objectives aim to assess any potential adverse reactions. The study commenced in January 2019 and is due for completion by December 2020. The main analysis of data will follow the intention to treat principle. The measurement of pain, the primary dependent variable, in each of the two groups will be compared using an independent t-test or a Mann-Whitney U test. Multivariable logistic regression analysis will be used if necessary.

The past two decades have seen an increase in medicinal cannabis research, which has consequently led to a number of countries, including Australia, introducing legislations allowing its use. Research has shown that medicinal cannabis can reduce chronic pain, neuropathic pain, cancer pain, chemotherapy-induced nausea, spasticity in Multiple Sclerosis, epileptic seizures, depression, and anxiety, as well as improve sleep, and reduce opioid prescription numbers. In Australia, it is estimated that more than 15% of the adult population live with persistent chronic pain or recurring pain lasting longer than 6 months. Neuropathic pain is experienced by approximately 8% of the population, and about 86% of patients with Multiple Sclerosis. It is associated with higher rates of unemployment, poor physical, psychological, and social functioning, significantly impaired health-related quality of life (HRQL) and sleep, and higher depression and anxiety than those with other chronic pain, and those without pain. Less than 35% of patients respond to conventional therapy, with others often receiving incomplete pain relief, which is commonly accompanied by conventional treatment-related side effects. Patient reported outcomes (PROs) can include symptoms, function, health-related quality of life (HRQL), and perceptions of treatment. In contrast to life-threatening conditions where survival endpoints may dominate HRQL considerations, PROs play a key role in chronic conditions, and are regarded as the gold standard for the assessment of pain. Collecting PROs with validated and reliable standardised questionnaires also allows comparisons between groups, and over time. Health care professionals need to be able to monitor the outcome of any treatment, and the existing evidence on PROs for medicinal cannabis has limitations such as; small sample sizes, lack of data collected over time, not using validated questionnaires, or not using comprehensive questionnaires for the condition treated. Participants studied under the controlled environment of randomised clinical trials may not always be representative of the entire spectrum of disease and health status seen in the general population currently accessing medicinal cannabis. Therefore, while clinical trials provide evidence of the efficacy of medicinal cannabis, the true gauge of how effective it is in practice comes from real-world evidence. The proposed research will assess quality of life in a large sample of people accessing medical cannabis over a 12 month period, using validated and comprehensive questionnaires relevant to their health condition.

This study aims to find the best dose and route for naloxone to safely reverse the respiratory depression of opioid poisoning. This is a randomised controlled trial where adult patients with opioid poisoning and respiratory depression will receive a 100mcg intravenous bolus of naloxone and either a 1600mcg intramuscular bolus of naloxone or saline placebo. Patients will then be managed along the standard opioid poisoning pathway (where they are closely observed and receive titrated 100mcg IV boluses 5 minutely as required to reverse respiratory depression). We anticipate that the patients receiving the 1600mcg intramuscular bolus will have less recurrence of opioid toxicity and less requirement for a naloxone infusion without having an increased rate of opioid withdrawal symptoms.

Families of children with type 1 diabetes (T1D) have reported high fat and high protein (HF/HP) meals as ‘difficult’ foods, causing prolonged hyperglycaemia after eating. A newly developed Hybrid Closed Loop (HCL) system with an Auto-Mode function uses real-time glucose levels to deliver basal insulin in micro amounts. Yet, there is little evidence on whether Auto-Mode is more effective than standard insulin pump therapy (Manual Mode) at reducing glucose excursions caused by HF/HP foods. This pilot study examines the impact of Auto-Mode on glucose excursions following HF/HP meals compared to Manual Mode. Participants are asked to consume standardised frozen beef lasagne and margherita pizza two nights a week for four weeks, under controlled conditions (4 meals in Manual Mode, 4 meals in Auto-Mode). It is hypothesised that the use of the Auto Mode will reduce glucose excursions after eating HF/HP foods when compared to the participant’s preferred insulin bolus pattern delivery in Manual Mode.

The objective of this study is to compare clinical and radiological outcomes in robotic-arm assisted TKA using mechanical alignment (MA TKA) versus robotic-arm assisted TKA with functional alignment (FA TKA). Both FA TKA and MA TKA are performed through similar skin incisions, robotic-guidance, and use identical implants. In MA TKA, bone is prepared and implants positioned to ensure that that the overall alignment of the leg is in neutral. In FA TKA, the bone is prepared and implants positioned to restore the natural alignment of the patient’s leg. Both of these surgical techniques provide excellent outcomes in TKA but it is not known which of the two techniques is better for patient recovery. Mako robotic-assisted TKA is an established treatment for arthritis of the knee joint. The positions of the implants and overall alignment of the leg are important as they influence how quickly the implants wear out and need replacing. The aim of this study is to determine if patient recovery is better with functionally aligned Mako robotic-assisted total knee arthroplasty (FA TKA) or mechanically aligned Mako robotic-assisted total knee arthroplasty (MA TKA)

Physical frailty (functional decline including muscle weakness) is one of the significant public health problems in elderly and is strongly correlated with poor health outcomes including cardiovascular diseases, but we do not know why this occurs. Frailty is associated with the initial stages of vascular dysfunction, inflammation and vitamin D deficiency. Low vitamin D levels are common among old people due to low dietary intake, less sun exposure and low level of production in the body. Previous research show that vitamin D supplements can improve both vascular function and physical frailty (including muscle function). Therefore, this project will determine if the reduction of inflammation using vitamin D supplementation can prevent people becoming frail.

The WSLHD HREC has approved project, certifying that the study proposal meets the requirements of the National Statement. The ethical approval for this research project is granted to be conducted at Blacktown Mount Druitt Hospital. The WSLHD HREC has been accredited by the NSW Department of Health as a lead HREC to provide the single ethical and scientific review of proposals to conduct research within the NSW public health system. This lead HREC is constituted and operates in accordance with the National Health and Medical Research Council’s National Statement on Ethical Conduct in Human Research and the CPMP/ICH Note for Guidance on Good Clinical Practice. The request to undertake the above protocol was reviewed by a subcommittee of members of the Scientific Advisory Committee (SAC) and the Human Research Ethics Committee (HREC) (Western Sydney Local Health District).

Anastomotic leakage (AL) is a serious complication of intestinal surgery, resulting in increased morbidity and mortality. This study aims to explore the simple and non-invasive approach of measuring the enzymes amylase and lipase in the drain fluid following a low extra-peritoneal anastomosis to detect AL at an early stage in the post-operative recovery. The hypothesis is based on the premise that luminal content of the colon is high in amylase and lipase and that drain fluid levels will rise above the normal serum reference range when an AL occurs. Who is it for? You may be eligible for this study if you are aged 18 or older, you have undergone a low or ultra low colorectal operation without a diverting loop ileostomy, and have had placement of a rectal tube and a pelvic drain at surgery. Patients undergoing the above surgical operations for any indication will be eligible for this study. Study details All participants enrolled in this study will have a sample of drain fluid collected daily from their surgical drain whilst the pelvic drain is in place. Insertion of pelvic drains is an element of the standard of care following colorectal surgery. It is hoped this research will determine whether enzymes such as amylase and lipase in fluids drained from an intestinal surgical site can indicate whether a patient has experienced an AL from their intestinal join following surgery, at an earlier time point than when diagnosed based on clinical signs.

Prostate cancer is the most common cancer in men, accounting for 25% of all cancer, with approximately 75% of those cancers arise posteriorly in the peripheral zone of the gland just adjacent to the rectum. Dose escalation in prostate cancer radiotherapy leads to improved tumor control rates however a dilemma arises in the balance between radiation dose and unacceptable rectal adverse effects (including diarrhoea and bleeding) which can complicate therapy in up to 20% of patients (due to the proximity of the prostate and the rectum). In some cases symptoms may evolve into a chronic course, negatively impacting on patients long term quality of life. Researchers have tried various technologies to protect rectal tissue when radiation is being delivered to the prostate. One such paradigm is the use of an inert protective synthetic hydrogel (made up of 90% water) called SpaceOAR, that is currently the only commercially available product for prostate-rectum separation. SpaceOAR is a transperineal inserted spacer (TIS) that is injected as a liquid into the anterior perirectal fat. When it solidifies, it forms a small protective barrier and space between the rectum and the prostate for the duration of radiotherapy treatment. Over a few months SpaceOAR dissolves and is absorbed by the body. A reasonable body of accumulated published literature has reported on the clinical utility of rectal spacers in phase II cohorts involving men undergoing external beam and brachytherapy to standard doses, with significant decrease in rectal toxicity. These results are echoed by the experience of Epworth Radiation Oncology, using conventional doses. The current trial is a prospective, non-randomized, single arm open-label study aimed at assessing the safety and efficacy of treating men with clinically localized prostate cancer to 82Gy using Intensity modulated Radiotherapy following the insertion of rectal SpaceOAR® hydrogel. The primary aims of this trial are to assess the inicidence of clinically notifiable toxicity and impact of health-related quality of life up to 36 months following radiotherapy.

We will evaluate the effects of a 10-week obesity prevention intervention Healthy Conversations @ Playgroup, to promote healthy lifestyle behaviours (dietary intake, physical activity, screen time and sleep) and support autonomy supportive parenting practices related to the four obesity risk behaviours in young children attending community playgroups. It is expected that children randomized to the Healthy Conversations intervention playgroups will show significantly better diet quality, physical activity, screen time, and sleep behaviours immediately after the intervention at 10 weeks and at 6-months follow-up, and significantly lower BMI z-scores at 6-months follow-up, than children randomized to the wait-listed control playgroups. Additionally, it is expected that parents of children randomized to the intervention playgroups will show significantly better parenting practices related to child obesity risk behaviours immediately after the intervention at 10 weeks and at 6-months follow-up, than children randomized to the wait-listed control playgroups .