Analyzing phase III studies in hospice/palliative care. a solution that sits between intention-to-treat and per protocol analyses: the palliative-modified ITT analysis.

Intention-to-treat (ITT) analyses are the standard way to evaluate randomized controlled trials (RCTs) to minimize Type I errors related to differential rates of noncompletion from one study arm. People in palliative care often die sooner than predicted as a direct result of disease progression, some of whom will be participating in RCTs and who will, therefore, withdraw or die after randomization for reasons unrelated to the intervention. This proportion of withdrawals is statistically negligible in other clinical disciplines, but commonplace in hospice/palliative care, creating a systematic bias away from the true effect.

Chronic pain in South Australia - population levels that interfere extremely with activities of daily living.

Objective: The prevalence of chronic pain in Australia has only been previously estimated for the state of New South Wales. The aim of this study was to focus estimates on pain severe enough to interfere markedly with daily function irrespective of contact with health services in another region, South Australia.

Methods: A whole of population random face-to-face survey method (n=2,973) was used, directly standardised against the whole population for age, gender, country of birth and rurality.

A community population survey of prevalence and severity of dyspnea in adults.

Given the progress in the symptomatic treatment of breathlessness, and the physical and psychological morbidity associated with chronic breathlessness, estimates of the size of the population that may benefit from better support become imperative. Prevalence estimates have varied widely (0.9% of clinical encounters to 32%) and have largely relied only on respondents who used clinical services.

Comfort in the last 2 weeks of life: relationship to accessing palliative care services.

Introduction: Specialised palliative care services (SPCS) aim to address the needs of patients and caregivers confronting life-limiting illnesses but only half of the potential cohort are referred. Randomised controlled trials of SPCS provision can no longer be ethically justified so there is a need to develop new methods to evaluate the net impact of SPCS for the whole community, not just for those who access SPCS. The aim of this study was to assess whether perceived comfort in the last 2 weeks of life was associated with accessing SPCS.

A randomized, double-blind, multi-site, crossover, placebo-controlled equivalence study of morning versus evening once-daily sustained-release morphine sulfate in people with pain from advanced cancer.

Diurnal variation in pain perception is recognized. The question of whether opioid prescribing should be adjusted to account for diurnal variation can be tested with the advent of once-daily sustained-release morphine. The study recruited 45 people with opioid-responsive pain on stable doses of analgesics and advanced cancer from five regional palliative care programs in Australia.

Comparison of three simulation-based training methods for management of medical emergencies.

Trainee medical officers (TMOs) participated in a study comparing three methods of simulation-based training to treat medical emergencies occurring in a hospital setting. The methods were: All groups had the same total teaching time. Participants (n=61) had an initial (pre-training) assessment by written tests, self assessment and simulations of medical emergencies ('VT' and 'HYPOglycaemia').

Self-selected exercise intensity during household/garden activities and walking in 55 to 65-year-old females.

This study determined whether some of the more vigorous household and garden tasks (sweeping, window cleaning, vacuuming and lawn mowing) were performed at a moderate intensity (3-6 METs or metabolic equivalents) by a representative sample of 50, 55 to 65-year-old women (X +/- SD; 59.3 +/- 3.1 years, 161.

Predicting walking METs and energy expenditure from speed or accelerometry.

Purpose: a) Compare the predictive potential of speed and CSA(hip) (Computer Science Applications accelerometer positioned on the hip) for level terrain walking METs (1 MET = VO2 of 3.5 mL.kg(-1).

The energy cost of household and garden activities in 55- to 65-year-old males.

This study measured the energy expenditure of four self-paced household and garden tasks to determine whether 55- to 65-year-old men performed them at a moderate intensity [3-6 metabolic equivalents (METs)] and to predict the activity intensity via indirect methods. Resting metabolic rate and oxygen consumption were measured using Douglas bags in 50 men (X +/- SD: 60.6 +/-3.

Anxiety in children having elective surgery.

One hundred and twenty children aged 5-12 years and their parents were interviewed preoperatively about anxiety and fear. Needles, postoperative pain, the unknown, and many unrecognizable people in the induction room were all reported as increasing anxiety for children. Effective modes of reducing children's anxiety were considered to be the prospect of eating after surgery, staff speaking directly to children in a friendly way, and having a television to watch.

Conventional coagulation and thromboelastograph parameters and longevity of continuous renal replacement circuits.

Objective: To determine the relationship between conventional and thromboelastograph (TEG) coagulation parameters and continuous renal replacement therapy (CRRT) circuit longevity.

Design: Conventional coagulation and TEG parameters were measured at the commencement of and during CRRT. Time to circuit cessation was measured and only circuits reaching a predetermined rise from baseline in the pressure gradient across the haemofilter were diagnosed as failing due to clotting.

The effect of the addition of epinephrine on early systemic absorption of epidural ropivacaine in humans.

Unlabelled: The addition of epinephrine to ropivacaine has not been recommended because ropivacaine has intrinsic vasoconstrictor properties. However, few pharmacokinetic data are available on the addition of epinephrine to epidural ropivacaine in humans. In this prospective, double-blinded study, we randomized patients having elective abdominal hysterectomy to receive epidural ropivacaine 1.

Effects of CNS site-directed carotid arterial infusions of bupivacaine, levobupivacaine, and ropivacaine in sheep.

Background: Previous preclinical safety studies in ewes have found intravenous levobupivacaine and ropivacaine to be less potent toward causing central nervous system (CNS) and cardiac toxicity than bupivacaine. Analogous cardiotoxicity has been demonstrated directly in various cardiac preparations ex vivo. Moreover, drug-related arrhythmogenicity has been demonstrated from direct CNS injection of local anesthetic agents in vivo, suggesting CNS-related cardiotoxicity.

Improving learning of a clinical skill: the first year's experience of teaching endotracheal intubation in a clinical simulation facility.

Background: All medical practitioners should be able to manage the airway of an unconscious patient. Endotracheal intubation is the most effective method of securing the airway but is a complex skill requiring much practice. Traditionally, endotracheal intubation has been taught on patients, but this is not ideal.

Pharmacokinetics and pharmacodynamics of twenty-four-hourly Kapanol compared to twelve-hourly MS Contin in the treatment of severe cancer pain.

Twenty-four patients with severe pain related to cancer completed a randomised, double-blind, double-dummy, crossover study examining morphine pharmacokinetics and pharmacodynamics when the same 24-h morphine dose was administered using two modified release oral morphine formulations; either one dose of Kapanol (a new sustained release polymer coated pellet formulation administered in capsule form, Glaxo Wellcome group of companies) per 24 h, or MS Contin (Purdue Frederick Company, Connecticut, USA) administered at 12-h intervals. The morphine dose was optimised for each patient using an immediate release morphine solution in the lead-in period to provide the most favourable balance between pain relief and side-effects. Patients were then randomly allocated to receive their 24-h morphine dose as either Kapanol or MS Contin in period 1.

Ketamine as an adjunct to morphine in the treatment of pain.

A double-blind multidose trial of the addition of ketamine (0-40 mg, i.m., 8 times per day) to intramuscular morphine therapy was undertaken in a 61-year-old man with chronic back pain related to osteoporosis who had received inadequate pain relief from anterior interbody fusion, dorsal column stimulation and morphine alone.

Chronopharmacokinetic variability in plasma morphine concentrations following oral doses of morphine solution.

Twenty-six patients with severe pain associated with cancer were entered into a study where they were required to take morphine mixture for 7 days. Prior to this, their morphine dose had been optimised to provide the most favourable balance between pain relief and side effects. After 6 days of taking their optimised morphine dose at 4-hourly intervals, the patients were admitted to the Pain Management Unit such that the doses from 18:00 h on day 6 were taken under direct nursing supervision.

Antinociceptive and motor effects of intrathecal morphine combined with intrathecal clonidine, noradrenaline, carbachol or midazolam in rats.

This study investigated antinociceptive effects of intrathecal morphine combined with intrathecal clonidine, noradrenaline, carbachol or midazolam in rats. Each animal received intrathecally, on 3 separate occasions (i) 2 micrograms morphine (M), (ii) a dose (D) of one of the non-opioid drugs, and (iii) a combination, 1/2(M+D), consisting of 1 microgram morphine plus half the dose of the non-opioid drug. Antinociceptive effects were assessed by the hot-plate and tail-flick tests over the duration of drug action.

Comparison of intermittent bolus with continuous infusion of epidural morphine in the treatment of severe cancer pain.

Twenty-eight patients with severe pain due to cancer, who could no longer obtain acceptable pain relief from optimised doses of oral opioids, were entered into a study which compared pain relief, satisfaction with pain therapy and estimates of neuropsychological functioning during treatment with spinally administered (i.e., epidural and intrathecal) morphine as either repeated bolus doses or as a continuous infusion.

Long-term spinal administration of morphine in cancer and non-cancer pain: a retrospective study.

Records of 313 patients who had been treated with spinal morphine via an implanted Port-A-Cath were reviewed. In 284 cases the Port-A-Cath was implanted for epidural delivery of morphine in patients with cancer-related pain. These patients were treated for a mean of 96 (range 1-1215) days.

Influence of polarity on dose-response relationships of intrathecal opioids in rats.

Dose-response curves were constructed for intrathecal morphine (M), oxymorphone (OM), hydromorphone (HM), diamorphine (DM), 14-hydroxydihydromorphine (OHM), oxycodone (OC), hydrocodone (HC) and fentanyl (F). Intrathecal catheters were placed in 69 rats under halothane/N2O anaesthesia. After recovery, baseline hot plate and tail flick latencies were measured, and a dose of opioid was given.

The efficacy of transdermal fentanyl in the treatment of postoperative pain: a double-blind comparison of fentanyl and placebo systems.

Forty consenting patients scheduled for abdominal surgery were entered into a double-blind comparison of the efficacy of transdermal fentanyl (TTS-fentanyl) and placebo (TTS-placebo) in the treatment of postoperative pain. All patients were allowed supplementary pethidine (25-50 mg) if pain relief was inadequate provided that their respiratory rate was greater than 10 breaths/min and there was no pronounced CNS depression. Visual analogue pain scores (VAPS), sedation rating scores (SRS), blood samples for the determination of fentanyl concentration, blood pressure, pulse and respiratory rate were determined hourly for 48 h from the time of TTS system application.