Home About us Contact
|
Home About us Contact | ||
|
|
||
Ethical Approval (ethical + approval)
Selected AbstractsThe validation of a rating scale to assess dietitians' use of behaviour change skillsJOURNAL OF HUMAN NUTRITION & DIETETICS, Issue 4 2008G. Bonner Background:, Evidence suggests that education alone is unlikely to elicit dietary-behavioural change (Contento, 1995). Consequently, many dietitians are moving from a traditional advice-giving role to one which utilises ,behaviour change skills' (BCS) in dietary counselling. BCS is an umbrella term used to cover a wide range of skills and techniques drawn from the fields of counselling, motivational interviewing (MI) and cognitive behavioural therapy (CBT). In order to assess the efficacy of this approach, a means of quantifying BCS-use is required. This two-stage study aimed to validate a newly-devised scale to assess dietitians' BCS-use in one-to-one dietary counselling. Methods:, Items for the scale were generated by drawing on the literature, syllabi for training in BCS and its parent disciplines (counselling, MI and CBT), and specialist dietitians. The resulting scale and manual were revised following assessment of content validity by expert panel and piloting. In stage one, 21 dietetic consultations were audiotaped and rated for BCS-use by three BCS-trained dietitians. Inter-rater agreement was calculated using the kappa statistic and intra-class correlation (ICC), to give a ,chance corrected' measure of agreement. Validity was tested using a psychologist's subjective assessment of BCS-use as a proxy ,gold-standard' compared with the dietitians' ratings, again using kappa and ICC. In stage two the scale was further revised before an additional 20 audiotaped consultations were analysed using the same procedure. Ethical approval for the study was given by the appropriate NHS and university research ethics committees. Results:, At stage one, although kappas were fairly poor for agreement on individual criteria, the ICC for overall scores indicated a ,fair' level of agreement, according to Shrout's (1998) classifications: ICC = 0.584 (CI 0.339,0.784). Results for validity were poor with the psychologist frequently rating higher than the dietitians. At stage two, following scale revision, results for inter-rater agreement improved with more criteria showing ,moderate' or ,substantial' agreement. Ten out of the 21 criteria achieved levels of agreement classified as ,fair' or higher for all three rater pairs. The ICC for overall scores improved to indicate ,moderate' agreement: ICC = 0.640 (CI 0.404,0.821). Validity results remained poor. Discussion:, The moderate level of overall inter-rater agreement observed in the revised scale is considered acceptable (Jones, 2006) and indicates this tool is useful. This measure is more relevant to the purpose of the tool than agreement on individual criteria given it is intended to classify consultations overall as low/medium/high use of BCS rather than to examine individual skills. However, in terms of validity, the discrepancy between dietitian and psychologist ratings requires further investigation. It is hypothesized that the dietitians had higher expectations of what a dietitian could achieve in terms of proficiency in BCS and, as such, rated more stringently than the psychologist. Achieving a clear picture of validity usually necessitates a series of assessments (Murphy & Davidshofer, 2005); the BCS rating scale is no exception with further testing required. Conclusions:, The revised scale shows acceptable inter-rater reliability and robust content validity in our study sample. However, quantitative examination of validity gave poor results and further assessment is required to provide a tool with which we can confidently assess dietitians' use of BCS. References, Contento, I., Balch, G.I., Bronner, Y.L. et al. (1995) The effectiveness of nutrition education and implications for nutrition education policy, programs, and research: a review of the research. J. Nutr. Educ.27, 355,364. Jones, J.M. (2006) Nutritional Screening and Assessment Tools. New York: Nova Science Publishers. Murphy, K.R. & Davidshofer, C.O. (2005) Psychological Testing , Principles and Applications, 6th edn. New Jersey: Pearson Education Inc. Shrout, P. (1998) Measurement reliability and agreement in psychiatry. Stat. Methods Med. Res. 7, 301,317. [source] A randomised, controlled trial of the effects of an energy-dense supplement on energy intake, appetite and blood lipids in malnourished community-based elderly patientsJOURNAL OF HUMAN NUTRITION & DIETETICS, Issue 4 2008G.P. Hubbard Background:, Disease-related malnutrition is common in the elderly and if left untreated may have severe consequences (Stratton & Elia, 2003). One of the strategies used to combat malnutrition is the use of high-energy, low-volume [18.8 kJ mL,1 (4.5 kcal ml,1)] nutritional supplements. This study aimed to investigate the effects of an energy dense supplement on energy intake, appetite and blood lipids in elderly patients at risk of malnutrition. Methods:, In this randomised, controlled, parallel study, 42 community-based patients (mean (SD) age: 84 (7.0) years, mean body mass index (BMI): 20.9 (3.5) kg m,2), identified as being at medium or high risk of malnutrition [Malnutrition Universal Screening Tool (MUST) (Elia, 2003)] were randomised (using standard randomisation methods) to receive either; (i) 1674 kJ day,1 (400 kcal day,1) (in 3 × 30 mL doses) of an energy-dense supplement (Calogen, Nutricia®) (n = 19) or (ii) dietary advice in the form of a standardised dietary advice sheet (n = 23), for 4 weeks. Energy intake, appetite, blood lipids [i.e. total cholesterol, low density lipoprotein (LDL) cholesterol (subset analysis only)], body weight, gastro-intestinal tolerance, product compliance and product acceptability were assessed during the 4 week study. Results are presented as mean (SD). Paired t -test and one way anova statistical analyses were undertaken using SPSS v15. Ethical approval for this study was obtained from the appropriate committee. Results:, Supplementation with the energy dense supplement significantly increased mean total daily energy intake by +1736 kJ (+415 kcal, P = 0.009) from 6456 (2330) kJ [1543 (557) kcal] to 8192 (1477) kJ [1958 (353) kcal], with no significant effect on voluntary food intake or appetite scores (for hunger, fullness and desire to eat). In the dietary advice group, although mean total daily energy intake was also significantly increased by +1105 kJ (+264 kcal, P = 0.026) from 5623 (2107) kJ [1344 (503) kcal] to 6728 (2029) kJ [1608 (485) kcal], it was significantly lower than in the energy dense group [-1464 kJ (-350 kcal), P = 0.012] at week 4. Both energy-dense and dietary advice groups maintained weight during the study. No significant adverse effects on blood lipid concentrations were observed in either group, with a significant decrease in total cholesterol concentrations [from 4.26 (1.0) mM to 3.96 (0.8) mM, P = 0.03] and LDL cholesterol concentrations [from 2.32 (0.6) mM to 2.06 (0.5) mM, P = 0.03] in the energy dense group (subset analysis, n = 9). Both supplementation with energy dense supplement and dietary advice were well tolerated with no gastro-intestinal side effects. The energy dense supplement was well accepted with >80% of patients rating it as pleasant and convenient, with an enjoyable taste. Compliance with the energy dense supplement was high, with 95% of patients consuming the recommended dose of 3 × 30 mL throughout the study. Discussion:, This study in elderly patients with or at risk of malnutrition suggests that the energy dense supplement is effective in significantly improving total intakes of energy with no suppression of appetite or voluntary dietary intake, enabling patients to maintain weight and that the energy dense supplement is well tolerated and accepted, with excellent compliance and no adverse effects on blood lipids. Conclusions:, This randomised controlled trial suggests that an energy-dense supplement is an effective, well tolerated and safe method of providing energy supplementation for the management of elderly patients with or at risk of malnutrition in clinical practice. References, Elia, M. (2003) The "MUST" report. Nutritional screening for adults: a multidisciplinary responsibility. Redditch, UK: BAPEN. Available at http://www.bapen.org.uk (accessed on 15 March 2008). Stratton, R.J., Green, C.J. & Elia, M. (2003) Disease-related malnutrition: an evidence-based approach. Oxford: CABI publishing. [source] ,It's magic stuff': The experiences of patients with ankylosing spondylitis taking anti-TNF-, medicationMUSCULOSKELETAL CARE, Issue 3 2009J. Stockdale MSc MCSP Abstract Introduction:,Several studies have identified the efficacy of anti-tumour necrosis factor-alpha (anti-TNF-,) treatment in ankylosing spondylitis (AS). However, few studies have explored the perceptions of patients taking this new medication. The aim of this study was to explore the impact of anti-TNF-, on the quality of life of people with AS. Methods:,A qualitative approach was adopted to provide a holistic understanding of participants' views and experiences in the context of their overall lives. Semi-structured interviews were undertaken and transcribed verbatim. Data were analysed using thematic analysis. Ethical approval and informed consent were obtained. Results:,Eight people participated and described a significant improvement in their physical and psychological status, leading to a more positive outlook on their life. Specific areas highlighted were employment, activities of daily living, hobbies and relationships with partners and family, some of which are not captured by current AS-specific outcome measures. Negative aspects of anti-TNF-, use were described as the inconvenience of monitoring and issues relating to travelling abroad. All participants expressed concern about the possibility of being withdrawn from treatment and the perceived impact this would have on their lives. Conclusions:,Anti-TNF-, treatment has a positive impact on the lives of people with AS, such that a major concern is being withdrawn from treatment, highlighting the need to provide tailored support to people being withdrawn from treatment. To capture the full impact of anti-TNF-, treatment, further consideration needs to be given to the choice of appropriate outcome measures. Copyright © 2008 John Wiley & Sons, Ltd. [source] Exploring the healthcare journey of patients with rheumatoid arthritis: A mapping project , implications for practiceMUSCULOSKELETAL CARE, Issue 4 2008Susan Oliver RN Abstract Objective:,Consumers of healthcare can reveal important insights into the personal challenges they experience when negotiating their health needs. The National Rheumatoid Arthritis Society (NRAS) wanted to explore the experiences of those with rheumatoid arthritis (RA) in order to understand the impact on the individual and on healthcare resources and benchmark care against published standards and guidelines. Methods:,A project was designed to explore the experiences of individuals with sero-positive RA who had been diagnosed for three years or less. Qualitative semi-structured interviews were used and combined with process mapping to explore the experiences of a purposeful sample of individuals with RA. The information generated was mapped and variances explored. Ethical approval was not required as the data were collected outside the National Health Service. Results:,Twenty-two participants' stories were mapped. Fifty per cent of participants sought a medical opinion within three weeks of symptom onset and the majority received a disease-modifying anti-rheumatic drug within six months from first presenting symptoms. Work-related issues were highlighted by 13 participants, and seven of these experienced job losses directly attributed to their diagnosis. Conclusions:,This unique mapping approach used qualitative research and process mapping to compare patient experiences against recognized standards and guidelines. These twenty-two stories reveal important insights into the challenges experienced in negotiating these healthcare journeys and the impact upon the individual as a result of variances in standards of care received. The participants in this study were chiefly self-motivated, informed and articulate, and did not reflect the broad ethnic, social or cultural diversity in the UK. Limitations must also be considered in relation to perceptions and recall of participants over a three-year period, as these may have altered over time and illness experience. Copyright © 2008 John Wiley & Sons, Ltd. [source] Ethical approval for research studiesCHILD ABUSE REVIEW, Issue 3 2001Loretta Light No abstract is available for this article. [source] Cohesion among nurses: a comparison of bedside vs. charge nurses' perceptions in Australian hospitalsJOURNAL OF ADVANCED NURSING, Issue 4 2001Wendy Chaboyer PhD RN Cohesion among nurses: a comparison of bedside vs. charge nurses' perceptions in Australian hospitals Aim.,This study examines the extent to which hospital nurses view their working environment in a positive sense, working as a cohesive group. Background.,Despite the fact that nursing in Australia is now considered a profession, it has been claimed that nurses are an oppressed group who use horizontal violence, bullying and aggression in their interactions with one and other. Methods.,After ethical approval, a random sample of 666 nurses working directly with patients and all 333 critical care nurses employed in three large tertiary Australian hospitals were invited to participate in the study in the late 1990s. A mailed survey examined the perceptions of interaction nurses had with each other. The hypothesis, that level of employment (either Level I bedside nurses or Level II/III clinical leaders) and area of work (either critical care or noncritical care) would influence perceptions of cohesion, as measured by the cohesion amongst nurses scale (CANS) was tested. Results.,In total 555 (56%) surveys were returned. Of these, 413 were returned by Level I and 142 by Level II/III nurses. Of this sample, 189 were critical care and 355 noncritical care nurses. There was no difference between Level I and II/III nurses in mean CANS scores. It is interesting to note that the item rated most positively was ,nurses on the units worked well together', however, the item rated least positive was ,staff can be really bitchy towards each other' for both Level I and II/III nurses. There was no difference in CANS scores between critical care and noncritical care nurses. Conclusions.,Nurses working in Australian hospitals perceived themselves to be moderately cohesive but, as would be expected in other work settings, some negative perceptions existed. [source] The challenges of caring in a technological environment: critical care nurses' experiencesJOURNAL OF CLINICAL NURSING, Issue 8 2008ITU cert, Mary McGrath MSc Purpose., This paper presents and discusses the findings from a phenomenological study which illuminated the lived experiences of experienced critical care nurses caring within a technological environment. Background., While nursing practice is interwoven with technology, much of the literature in this area is speculative. Moreover, there is a debate as to whether and how ,high tech' and ,high touch' are reconcilable; this orientation is referred to as the optimism vs. pessimism debate. On a personal level, the motivation for this study came from the author's 13 years' experience in the critical care area. Method., Following ethical approval, 10 experienced nurses from two cardiothoracic critical care units in Ireland participated in the study. A Heideggerian phenomenological methodology was used. Data collection consisted of unstructured interviews. A method of data analysis described by Walters was used. Findings., The findings provide research-based evidence to illuminate further the optimistic/pessimistic debate on technology in nursing. While the study demonstrates that the debate is far from resolved, it reveals a new finding: life-saving technology that supports the lives of critically ill patients can bring experienced nurses very close to their patients/families. The three main themes that emerged: ,alien environment', ,pulling together' and ,sharing the journey' were linked by a common thread of caring. Conclusion., Experienced critical care nurses are able to transcend the obtrusive nature of technology to deliver expert caring to their patients. However, the journey to proficiency in technology is very demanding and novice nurses have difficulty in caring with technology. Relevance to clinical practice., It is recommended that more emphasis be placed on supporting, assisting and educating inexperienced nurses in the critical care area and that the use of technology in nursing be given serious consideration. [source] Transhepatic lactate gradient in relation to liver ischemia/reperfusion injury during major hepatectomiesLIVER TRANSPLANTATION, Issue 12 2006Kassiani Theodoraki Hepatectomies performed under selective hepatic vascular exclusion are associated with a series of events culminating in ischemia/reperfusion injury, a state that shares common characteristics with situations known to result in global or regional hyperlactatemia. Accordingly, we sought to determine whether lactate is released by the liver during hepatic resections performed under blood flow deprivation and what relation this has to a possible systemic hyperlactatemic state. After ethical approval, 14 consecutive patients with resectable liver tumors subjected to hepatectomy under inflow and outflow occlusion of the liver were studied. Lactate concentrations were assessed in simultaneously drawn arterial, portal venous, and hepatic venous blood before liver dissection and 50 minutes postreperfusion. Moreover, the transhepatic lactate gradient (hepatic vein , portal vein) was calculated to see if there was net production or consumption of lactate. Before hepatic dissection, the transhepatic lactate gradient was negative, suggesting consumption by the liver. Fifty minutes after reperfusion, this gradient became significantly positive, demonstrating release of lactate by the liver (0.12 ± 0.31 vs. ,0.38 ± 0.30 mmol/L, P < 0.05). The magnitude of lactate release correlated with systemic arterial lactate levels at the same time point (r2 = 0.63, P < 0.001). A weaker but significant correlation was demonstrated between the transhepatic lactate gradient postreperfusion and systemic arterial lactate levels 24 hours postoperatively (r2 = 0.41, P = 0.013). A strong correlation between the transhepatic lactate gradient postreperfusion and peak postoperative aspartate aminotransferase values was also demonstrated (r2 = 0.73, P < 0.001). The liver becomes a net producer of lactate in hepatectomies performed under blood flow deprivation. This lactate release can explain some of the systemic hyperlactatemia seen in this context and relates to the extent of ischemia/reperfusion injury. Liver Transpl 12:1825-1831, 2006. © 2006 AASLD. [source] Do hypermobile subjects without pain have alteration to the feedback mechanisms controlling the shoulder girdle?MUSCULOSKELETAL CARE, Issue 3 2010H.M. Jeremiah BSc (Hons), MMACP Abstract Objectives:,It has been reported that hypermobile subjects have proprioceptive deficits. However, it remains unclear whether pain-free subjects with hypermobility also have deficits. Methods:,Ten subjects with hypermobility and nine without hypermobility were recruited following ethical approval and informed consent. Shoulder mobility, joint position sense (JPS) and a reflex of trapezius evoked from arm afferents were compared. Results:,There was greater shoulder mobility in the hypermobile group (p = 0.004). There were no differences in shoulder JPS between the groups (p = 0.27), although, the hypermobile group displayed a larger degree of variability (p = 0.014). Finally, there were no differences in the latency of upper and lower trapezius reflexes evoked from arm afferents (p = 0.86 and 0.98, respectively). Conclusions:,In a group of people with hypermobility without shoulder problems, there was no difference in either shoulder JPS or reflex latency when compared with a non- hypermobile group. The relevance of pain to proprioceptive deficits is discussed. © 2010 John Wiley & Sons, Ltd. [source] IRB approval: Consideration of power is essential for ethical approvalNEUROUROLOGY AND URODYNAMICS, Issue 4 2005Peter Herbison [source] The Kalgoorlie Otitis Media Research Project: rationale, methods, population characteristics and ethical considerationsPAEDIATRIC & PERINATAL EPIDEMIOLOGY, Issue 1 2008Deborah Lehmann Summary Otitis media (OM) is one of the most common paediatric illnesses for which medical advice is sought in developed countries. Australian Aboriginal children suffer high rates of OM from early infancy. The resultant hearing loss can affect education and quality of life. As numerous factors contribute to the burden of OM, interventions aimed at reducing the impact of single risk factors are likely to fail. To identify key risk factors and understand how they interact in complex causal pathways, we followed 100 Aboriginal and 180 non-Aboriginal children from birth to age 2 years in a semi-arid zone of Western Australia. We collected demographic, obstetric, socio-economic and environmental data, breast milk once, and nasopharyngeal samples and saliva on seven occasions. Ear health was assessed by clinical examination, tympanometry, transient evoked otoacoustic emissions and audiometry. We considered the conduct of our study in relation to national ethical guidelines for research in Aboriginal and Torres Strait Islander health. After 1 year of community consultation, the study was endorsed by local committees and ethical approval granted. Fieldwork was tailored to minimise disruption to people's lives and we provided regular feedback to the community. We saw 81% of non-Aboriginal and 65% of Aboriginal children at age 12 months. OM was diagnosed on 55% and 26% of routine clinical examinations in Aboriginal and non-Aboriginal children respectively. Aboriginal mothers were younger and less educated, fewer were employed and they lived in more crowded conditions than non-Aboriginal mothers. Sixty-four per cent of Aboriginal and 40% of non-Aboriginal babies were exposed to environmental tobacco smoke. Early consultation, provision of a service while undertaking research, inclusion of Aboriginal people as active members of a research team and appropriate acknowledgement will assist in ensuring successful completion of the research. [source] Prospective blinded comparison of surface versus wire electromyographic analysis of muscle recruitment in shoulder instabilityPHYSIOTHERAPY RESEARCH INTERNATIONAL, Issue 1 2009Anju Jaggi Abstract Background.,This pilot study assesses level of agreement between surface and fine-wire electromyography (EMG), in order to establish if surface is as reliable as fine wire in the diagnosis and treatment of abnormal muscle patterning in the shoulder.,Method.,Eighteen participants (11 female) with unstable shoulders were recruited after written consent and ethical approval. Anthropometric information and mean skinfold size for triceps, subscapular, biceps and suprailiac sites were obtained. Triple-stud self-adhesive surface electrodes ('Triode'; Thermo Scientific, Physio Med Services, Glossop, Derbyshire, England) were placed over pectoralis major (PM), latissimus dorsi (LD), anterior deltoid (AD) and infraspinatus (IS) at standardized locations. Participants performed five identical uniplanar standard movements (flexion, abduction, external rotation, extension and cross-body adduction). After a 20-minute rest period, a dual-needle technique for fine-wire insertion was performed and the standard movements were repeated. An experienced examiner in each technique reported if muscle activation patterns differed from agreed normal during any movement and were blinded to the other test results. Sensitivity, specificity and Kappa values for level of agreement between methods were calculated for each muscle according to the method of Altman (1991).,Results.,Fifteen participants were successfully tested. Sensitivity, specificity and Kappa values between techniques for each muscle were PM (57%, 50%, 0.07), LD (38%, 85%, 0.22), AD (0%, 76%, ,0.19) and IS (85%, 75%, 0.6). Only IS demonstrated high sensitivity and specificity and a moderate level of agreement between the two techniques. There was no correlation between skinfold size and agreement levels.,Conclusion.,The use of surface EMG may help to classify types of shoulder instability and recognize abnormal muscle patterns. It may allow physiotherapists to direct specific rehabilitation strategies, avoiding strengthening of inappropriate muscles. It has a reasonable degree of confidence to evaluate IS but may have poor sensitivity in detecting abnormal patterns in PM, LD and AD. Further work is required to see if investigator interpretation may have been a factor for the poor level of agreement. Copyright © 2008 John Wiley & Sons, Ltd. [source] An Eastern art form for a Western disease: randomised controlled trial of yoga in patients with poorly controlled insulin-treated diabetesPRACTICAL DIABETES INTERNATIONAL (INCORPORATING CARDIABETES), Issue 6 2002Dr David Kerr MD FRCP FRCPE Consultant Physician Abstract There is increasing interest in the use of complimentary therapies. At present, there is a paucity of data examining the effectiveness of such therapies in patients with diabetes. We have examined the influence of providing yoga for patients with diabetes that is poorly controlled despite the best efforts of the multidisciplinary team. After obtaining ethical approval, 37 patients with poorly controlled diabetes were randomised to a traditional intensive education programme and simple exercises or a 16 week (32 session) Hatha yoga plan. Participation in regular yoga sessions did not improve glycaemic control but insulin requirements remained stable in the yoga group and increased in the controls. Although quality of life was not altered, all but one subject in the yoga group opted to continue with yoga long term after completion of the study. Copyright © 2002 John Wiley & Sons, Ltd. [source] The Vulnerability and sexual abuse of people with learning disabilitiesBRITISH JOURNAL OF LEARNING DISABILITIES, Issue 2 2007Nicholas Guy Peckham Accessible summary ,,People with learning disabilities are more likely to experience sexual things happening to them when they do not want them to. This is called sexual abuse. ,,A group was started to help some women who have been sexually abused. ,,Women who wanted to attend the group were given information about it and asked on three separate occasions if they wanted to attend. Their carers helped them and went to a different group upstairs in the same building. ,,We found that the group helped the women feel less scared and depressed and helped the women's carers understand them better. ,,This research matters because it helped the women move on with their lives and will help others who want to start a group. Summary In his capacity as a Clinical Psychologist the author provides psychological support to people with learning disabilities living in hospital and in the community. Frequently, the problem behaviour highlighted in referral letters (such as sexualized behaviour, anger management or self-harm) is formulated as relating to a past history of abuse and neglect which they had experienced. In view of increasing client referrals and a limited research literature the author established a small team, developed and then piloted a survivors' group for women with a learning disability. The pilot achieved ethical approval and the survivors' group ran concurrently with an educational support group for their carers. For more details about this pilot study see Peckham (2005)Developing, delivering and evaluating a survivors group pilot in Northumberland for women with significant learning disabilities who have been sexually abused. Unpublished DClinPsych Thesis, University of Newcastle, Newcastle upon Tyne; and Peckham et al. (2007). These articles summarize the research literature in the area of sexual abuse and describe, in detail, the problem of delivering and evaluating a survivors' group for women with learning disabilities. [source] Gaining ethical approval for research into sensitive topics: ,two strikes and you're out?',BRITISH JOURNAL OF LEARNING DISABILITIES, Issue 4 2003Sarah-Jane Hays Summary Researching sensitive topics, such as the treatment of men with intellectual disabilities and sexually abusive behaviour, present a number of ethical issues for researchers. This paper describes our experiences in working with Multi-Centre Research Ethics Committees on a research proposal designed to assess the efficacy of cognitive behaviour therapy for men with intellectual disabilities who are at risk of sexual offending. After submitting to three Multi-Centre Research Ethics Committees and spending a year trying to get ethical approval, we questioned whether: , , the issue of study design should be part of the Multi-Centre Research Ethics Committees remit; , , Multi-Centre Research Ethics Committees were sufficiently responsive to concerns raised by researchers; , , Multi-Centre Research Ethics Committees always understood the research; and , , the Central Office for Research Ethics Committees should disallow re-submission after rejection by two Multi-Centre Research Ethics Committees (,two strikes and you're out'). [source] Use of intravenous steroids at induction of anaesthesia for adult tonsillectomy to reduce post-operative nausea and vomiting and pain: a double-blind randomized controlled trialCLINICAL OTOLARYNGOLOGY, Issue 1 2006S. McKean Objective:, To assess the effectiveness of intravenous steroids at induction of anaesthetic to reduce post-operative nausea and vomiting and pain after adult tonsillectomy. Design:, Prospective, double-blind, randomized, placebo controlled trial, with ethical approval, following Consolidated Standards of Reporting Trials guidelines. Setting:, District General Hospital in Scotland, UK. Participants:, Seventy-two adults between 16 and 70 years, American Association of Anaethetists (ASA) 1, listed for elective tonsillectomy. Intervention:, Single dose of either 10 mg of dexamethasone or 2 mL of saline after induction with a consistent anaesthetic technique. Main outcome measures:, Patients filled in a visual analogue scale relating to pain and post-operative nausea and vomiting for the day of operation and 7 days after operation. The time to first ingestion of food and drink after operation was also noted. Results:, Data completion rate of 64% (46 of 72 patients enrolled). Statistically significant relative decrease (62%P = 0.001) in the incidence of post-operative nausea and vomiting was seen in those treated with dexamethasone. Statistically significant relative decrease (23%P = 0.016) in post-operative pain scores for the day of operation was seen in those treated with dexamethasone. Significant decrease (17.5%, P < 0.001) in mean pain score for seven post-operative days was seen in those treated with dexamethasone. No adverse effects were seen. Conclusions:, Dexamethasone given as a single dose of 10 mg at induction of anaesthesia for adult tonsillectomy is an effective, safe and inexpensive method for reducing morbidity in adult tonsillectomy. [source] | ||||||||||||||||||||||