The IDvIP Trial: A two-centre randomised double-blind controlled trial comparing intramuscular diamorphine and intramuscular pethidine for labour analgesia

<p>Abstract</p> <p>Background</p> <p>Intramuscular pethidine is routinely used throughout the UK for labour analgesia. Studies have suggested that pethidine provides little pain relief in labour and has a number of side effects affecting mother and neonate. It can cause nausea, vomiting and dysphoria in mothers and can cause reduced fetal heart rate variability and accelerations. Neonatal effects include respiratory depression and impaired feeding. There are few large studies comparing the relative side effects and efficacy of different opioids in labour. A small trial comparing intramuscular pethidine with diamorphine, showed diamorphine to have some benefits over pethidine when used for labour analgesia but the study did not investigate the adverse effects of either opioid.</p> <p>Methods</p> <p>The Intramuscular Diamorphine versus Intramuscular Pethidine (IDvIP) trial is a randomised double-blind two centre controlled trial comparing intramuscular diamorphine and pethidine regarding their analgesic efficacy in labour and their side effects in mother, fetus and neonate. Information about the trial will be provided to women in the antenatal period or in early labour. Consent and recruitment to the trial will be obtained when the mother requests opioid analgesia. The sample size requirement is 406 women with data on primary outcomes. The maternal primary outcomes are pain relief during the first 3 hours after trial analgesia and specifically pain relief after 60 minutes. The neonatal primary outcomes are need for resuscitation and Apgar Score <7 at 1 minute. The secondary outcomes are an additional measure of pain relief, maternal sedation, nausea and vomiting, maternal oxygen saturation, satisfaction with analgesia, whether method of analgesia would be used again, use of Entonox, umbilical arterial and venous pH, fetal heart rate, meconium staining, time from delivery to first breath, Apgar scores at 5 mins, naloxone requirement, transfer to neonatal intensive care unit, neonatal haemoglobin oxygen saturation at 30, 60, 90, and 120 mins after delivery, and neonatal sedation and feeding behaviour during first 2 hours.</p> <p>Discussion</p> <p>If the trial demonstrates that diamorphine provides better analgesia with fewer side effects in mother and neonate this could lead to a change in national practice and result in diamorphine becoming the preferred intramuscular opioid for analgesia in labour.</p> <p>Trial Registration</p> <p><a href="http://www.controlled-trials.com/ISRCTN14898678">ISRCTN14898678</a></p> <p>Eudra No: 2006-003250-18, REC Reference No: 06/Q1702/95, MHRA Authorisation No: 1443/0001/001-0001, NIHR UKCRN reference 6895, RfPB grant PB-PG-0407-13170_IR5</p

Adolescent quality of life: A school-based cohort study in Western Australia.

Background: Quality of life (QOL) has received increasing attention in pediatrics medicine recently. Improving QOL is the primary justification for many interventions, medications and therapies. The present study is a school-based longitudinal study which aims to investigate the factors affecting QOL of adolescents in Western Australia over a 6-month period. Methods: A generic self-reported questionnaire was administered twice to participants from 20 schools in Perth at 6 months apart. In addition to QOL scores and physical health status, demographic and other information was also collected. For the cohort of 363 students who participated in the initial survey, 300 of them completed the second questionnaire.Results: A significant change in QOL score between baseline and 6 months was observed. Results from fitting a hierarchical mixed regression model indicated that 55% of the variation in QOL was due to differences between individuals, and was significantly associated with age, control, opportunities and perceptions of physical health, while the remaining variance component could be attributed to within-individual changes. Improved control and opportunities appeared to have a significant positive impact on QOL, whereas increasing age and deterioration in physical health had the opposite effect. Conclusions: The hierarchical regression analysis has enabled valid inferences to be made based on the observed longitudinal data. Perceptions of physical health, age, control and opportunities available are related to adolescent QOL. The findings have implications on evidence-based practices and childhood health issues

Climate-dependent variations in leaf respiration in a dry-land, low productivity Mediterranean forest: the importance of acclimation in both high-light and shaded habitats

1. Climate-driven changes in leaf respiration (R) in darkness have the potential to determine whether low productivity ecosystems exhibit positive or negative carbon balances.\ud \ud 2. We investigated whether sustained exposure to full sunlight, shade and seasonal drought alters the temperature response of leaf R of field-grown Quercus ilex subsp. ballota in a dry-land continental Mediterranean ecosystem. The plants studied, experience large diurnal and seasonal variations in temperature.\ud \ud 3. Whilst growth irradiance impacted on photosynthesis, it had little effect on the short-term temperature dependence of leaf R. Moreover, although basal rates of leaf R (i.e. rates of R at a common measuring temperature) were higher in sun-exposed than shade-exposed leaves, growth irradiance had little impact on the degree of acclimation to seasonal changes in temperature and/or moisture. Basal rates of leaf R were higher in winter than summer in both sun-exposed and shaded plants. Estimated Q10 values (i.e. proportional increase in R per 10 °C rise in temperature) for leaf R were greater in winter than summer; however, no seasonal variation was found in the apparent activation energy (E0) of leaf R. These observations were used to construct a simple Arrhenius model that fully accounted for both daily and seasonal variations in the temperature dependence of R in both sun-exposed and shaded plants. Crucial to the model was accounting for the seasonal and irradiance-dependent shifts in the basal rate of leaf R.\ud \ud 4. Although the balance between daily R and photosynthesis increased markedly in summer (particularly under full sun), the increase in this ratio was markedly less than would have been the case if leaf R had not acclimated to the high average day time temperatures in summer.\ud \ud 5. It is concluded that seasonal acclimation of leaf R plays a crucial role in determining the viability of tree growth in dry-land, low productivity forest ecosystems