ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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32856 results sorted by trial registration date.
  • Efficacy of 48-hour intravenous (IV) lidocaine infusions in open colorectal surgery.

    Background Although i.v. lidocaine is used as a perioperative analgesic in abdominal surgery, evidence of efficacy in terms of surgical recovery, pain scores, and opioid use is limited. The infusion dose and duration remain unclear. This study aimed to investigate the effect of a longer low-dose 48-hour infusion regimen on these outcomes. Methods Fifty-eight adult patients undergoing elective open colorectal surgery were randomised into the lidocaine group (1.5 mg kg-1 followed by 1 mg kg-1 h-1 infusion for 48 hours) and control group (administered equal volumes of normal saline). After surgery, patients were given a patient-controlled analgesia (PCA) machine and time to first bowel movement (primary outcome) and flatus were recorded. Postoperative pain scores (numeric rating scale) and fentanyl PCA consumption were assessed for 72 post-operative hours. Results There was no significant difference in time to first bowel movement [80.1 (42.2) vs 82.5 (40.4) hours; (P=0.83)], time to first flatus [64.7 (38.5) vs 70.0 (31.2) hours; P=0.57], length of hospital stay [9 (8–13) vs 11 (9–14) days; P=0.53], nor post-operative pain scores in the lidocaine vs control arms. Cumulative opioid consumption was significantly lower in the lidocaine vs the control group from 24 hours onwards. At 72 hours, cumulative opioid consumption (mcg fentanyl) in the lidocaine group [1570 (825-3587)] was over 40% lower than in the placebo group [2730 (1778-5327); P=0.039]. Conclusion A 48-hour low-dose i.v. lidocaine infusion reduces postoperative opioid consumption. This is not associated with faster return of bowel function, hospital discharge, or lower pain scores.

  • A quasi-experimental repeat cross-section evaluation to determine the effectiveness of the OPAL (Obesity Prevention and Lifestyle) Program at increasing healthy weight in children (9-11 years).

    A quasi-experimental repeat cross section study design to determine the effectiveness of the childhood obesity prevention program called OPAL (Obesity Prevention and Lifestyle) run in 20 communities across South Australia.

  • High intensity progressive resistance training for postmenopausal women with low to very low bone mass: The LIFTMOR trial

    Bone responds to mechanical stimuli, with the greatest response from high loads being applied quickly. High loads have remain unexamined in postemenopausal women with low bone mass due to the perceived risk of injury. The LIFTMOR trial was developed to see if the loads required to obtain the a greater bone response are both safe and effective in postmenopausal women with low to very low bone mass.

  • Treating postnatal depression with psychotherapy inclusive of the mother-baby relationship.

    Post-natal depression affects a mother's wellbeing and also has developmental and emotional risks for her child. More research is urgently required on interventions employing combined treatment for post-natal depression and the parenting relationship. This study trials an adapted interpersonal psychotherapy (IPT) for post-natal depression which incorporates a focus on the mother-child relationship and uses attachment theory to inform that focus where required. The study is a controlled trial with cluster-allocation of participants identified by their maternal and child health nurse as being at risk. Participants who meet criteria for post-natal depression will be allocation in groups of between three and five to either a group therapy of a 10-week IPT with mother-child content (IPT-MC), or to treatment as usual via their maternal and child health nurse. The trial addresses the need for investigations into combined mother-child relational and mood interventions. It recognises difficulties associated with the recruitment of new mothers suffering from depression and attempts strategies to overcome these barriers to care.

  • Efficacy of D-Cycloserine in combination with intensive exposure therapy in the treatment of obsessive compulsive disorder (OCD) in children

    The aim of the study is to examine whether D-Cycloserine can augment graded exposure therapy for children and adolescents with Obsessive Compulsive Disorder. D-Cycloserine is an antibiotic drug traditionally used to treat tuberculosis. D-Cycloserine is a glutamatergic partial N-methyl-D-aspartate (NMDA) agonist, which has recently been shown to facilitate fear extinction in humans and animals and has also demonstrated to improve treatment outcome when combined with exposure therapy in social phobia, acrophobia, or fear of heights and OCD in adult samples. The drug has recently been used to augment exposure therapy for children and adolescents with OCD.

  • A healthy volunteer study to determine the maximum tolerable dose of the dexmedetomidine transdermal system and how much is available in the body.

    This is a second in human study for DMTS. This open-label study consists of 2 parts: Part 1 is a single ascending dose study to determine the maximum tolerated dose of DMTS. Part 2 is bioavailability study The primary objective of this study is to determine the maximum tolerable dose (MTD) of the DMTS following a single 3 -day application (Part 1) and how much dexmedetomdine from the DMTS at the MTD is available in the body after a 3-day treatment (Part 2).

  • Effects of reduced sitting on toddlers’ cognitive development: a cluster randomised controlled trial.

    Our primary aim is to assess the effects of reducing sitting time during childcare on Executive Functions in a cluster randomised controlled trial in Australian toddlers from low socio-economic families. We hypothesise that at 15-month follow-up, toddlers in centres allocated to the intervention group will have improved their cognitive development by 0.5 SD more than toddlers in childcare centres randomly allocated to the control group. The secondary aims are to examine the effects of the intervention (i) on time spent in total sitting and bouts of sitting (ii) on time spent in total physical activity and moderate-to-vigorous physical activity (iii) on bone mineral density and (iv) and on cardiovascular health.

  • Effects of noradrenergic and antimuscarinic agents on upper airway muscle activity during sleep

    To determine if sleep-related reductions in upper airway muscle activity during sleep will be higher after a combined noradrenergic/antimuscarinic intervention compared to placebo.

  • The Impact of face-to-face and web-based simulation training for ward nurses regarding patient deterioration and patient safety.

    In this study we aim to address patient safety in relation to first responders’ ‘failure to rescue’ deteriorating patients with a focus on enhancing the assessment and management of clinical deterioration. Over the last 7 years we have developed a face-to-face and web based educational program known as First2Act(Web) http://first2actweb.com/ which has had a demonstrated impact on educational outcomes and in a preliminary study a significant impact on clinical performance. The objectives of this study are to measure and compare the cost- effectiveness and clinical impact of in-situ face-to-face and web-based simulation programs in the management of patient deterioration and related patient outcomes. Based on these programs our intentions are to train nurse participants in primary responses to emergencies (the first 8 minutes) in medical wards at Monash Health and St John of God Health Care and other hospitals, using either in-situ face-to-face or web based version of First2Act. The impact of these interventions will be determined through quantitative and qualitative approaches; economic analyses and patient notes review (time series analyses) to measure quality of care and patient outcomes. This will enable us to determine the clinical impact of the intervention programs in relation to resource implications. It is anticipated that this program will reduce the number of in-hospital adverse events, length of stay and hospital costs whilst adding to our understanding of the barriers and enablers to effective decision-making in clinical deterioration and the utility of simulation in the preparation of first responders. Subsequent recommendations and final programs will be made available to the Victorian and International communities

  • Further enabling care at home for people living with dementia

    Negative outcomes for the person living with dementia and their family carer can be anticipated from inadequate carer support. The Further Enabling Care at Home program involves systematic assessment of the carer’s support needs plus guidance to access existing services. We aim to test this program with family carers of people with dementia upon hospital discharge. Objectives are to: 1. Test how well the Further Enabling Care at Home program supports preparedness to care – and subsequent caregiving sustainability - in family carers of people living with dementia. 2. Determine the feasibility of translating the program into routine practice. Hypotheses for this study are that the program will help prepare families to sustain their caregiving role and reduce hospital/residential care use by the people with dementia receiving their care; also that costs of providing the program will be outweighed by savings. Research plan The 154 included dyads will each comprise a person living with dementia being discharged home from hospital and their family carer. In a single-blind randomised controlled trial, dyads will be assigned to receive either usual care or usual care plus the new program. Data will be collected from all carers at discharge, 5 weeks post-discharge, and 10 weeks post-discharge using questionnaires administered over the telephone. The primary outcome evaluated for carers is their preparedness to provide care. Carer data will establish patients’ use of health/residential services during the 10-week period. Intention-to-treat regression analyses will determine differences in carer and patient outcomes over time associated with group assignment. Cost consequence analyses plus qualitative and process evaluations will further inform recommendations for translation into practice.

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