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{Insert UQ Logo} University of Queensland School Of Nursing, Midwifery & Social Work Research Proposal HLTH 7308 Development of a Research Proposal [CLICK ONCE AND INSERT PROPOSAL TITLE] [CLICK ONCE AND INSERT STUDENT NAME] [CLICK ONCE AND INSERT STUDENT ID] [CLICK ONCE AND INSERT SUPERVISOR(S) NAME] [CLICK ONCE AND INSERT DATE OF SUBMISSION]
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RESEARCH PROPOSAL1 1. Introduction Nonsteroidal anti-inflammatory drugs (commonly abbreviated as NSAIDs) refer to a class of drugs that decrease fever, prevent blood clots, reduce pain, and, in higher quantities, reduce inflammation (Pountos, Georgouli, Bird, & Giannoudis, 2011). The side effects depend on the particular medication but principally include an intensified danger of intestinal ulcers and hemorrhages, kidney disease, and heart failure.The terminology non-steroid differentiates these medications from steroids, which despite having an analgesic and eicosanoid action lead to a wide range of other side effects(Soleimanpour et al, 2012). 1.1 Background to the study Used for the first time in 1960, the terminology is used to distance these medications from steroids.Nonsteroidal anti-inflammatory drugsfunction by constraining the action of cyclooxygenase enzymes. In the human cell, these particular enzymes take part in the joining up of significant organic mediators that is the thromboxanes that are involved in the blood coagulation and prostaglandins that are involved in the inflammation (Snir et al, 2008). For a long time since their inception, these drugs are known for their efficiency in curing renal colic despite the fact that others such as opioids have been proved useful. Despite their recommendation for the controlling of renal colic, the comparative effectiveness of these particular medications remains uncertain(Springhart et al, 2006). 1.2 Purpose of the research (aims) NSAIDs are generally used to treat acute or chronic conditions in which inflammation and pain are present.NSAIDs arenormallyutilizedfor thecharacteristicrelief ofdisorders such
RESEARCH PROPOSAL2 as renal colic, ileus, headache, migraine, low back pains, and rheumatoid arthritis among others (Tadros, 2013).Renal colic disease refers to a form of abdominal discomfort usually led by kidney stones.Renal colic characteristically starts in the side of the victim and frequently gives out to the groin or the hypochondrium (the section of the frontal stomach divider below the costal precincts)(Perazella, 2009).This ailment is archetypally colicky (appears in waves) owing to the ureteric peristalsis, but might be continuous. It is frequently designated as one of the sturdiest aching sensations known.Prognosis and treatmentof renal colic can be done using NSAIDs such as ibuprofen, diclofenac, and antispasmodics. Opioids such as hydromorphone, morphine, and fentanyl are also used to cure renal colic and just like NSAIDs, they are associated with some side effects such as vomiting, nausea, respiratory depression, hypotension, and sedation(Davenport, Timoney, & Keeley, 2005). The primary purpose of this research paper is to investigate whether Non-Steroidal Anti-Inflammatory Drugs are more effective in treating pain related to acute renal colic than opioids in adults. Research questions What are the disadvantages and benefits of NSAIDs and opioids in the treatment of acute renal colic among the adults? What are some of the side effects associated with the usage of NSAIDs and opioids medications when used to manage renal colic? These are some of the research questions this study will respond to.
RESEARCH PROPOSAL3 1.3 Significance of the study This study will be of help to both adult victims suffering from renal colic discomfort and medical specialists who come across this malady. Other parties such as scholars can use the knowledge they derive for the research content to expound on their understandings. 2.Literature Review Pathan, Mitra, and Cameron (2018) in their aim to review the efficiency of NSAIDs, Paracetamol, and Opioids noted that NSAIDs are the same to paracetamol or opioids in the management of severe renal colic discomfort among the adult at 30min. They also discovered that there will a lesser amount of vomiting and rarer necessities for salvage analgesia with NSAIDs as opposed to when they use opioids.Victims administered with NSAIDs need a smaller amount of salvage analgesia than those treated with opioids like paracetamol. The researchers also noted that despite the heterogeneity observed between the included investigations as well as the general eminence of the sign, the results of a reduced necessity for salvage analgesia and less adversative occurrences, plus the concrete benefits of easiness of administration, indicate that NSAIDs ought to be the chosen analgesic preference for victims with renal colic presented to the Emergency Department (ED). Holdgate & Pollock (2005) in their aim toscrutinizethe advantages anddrawbacksof opioidsand NSAIDsfor thecontrolling of pain in critical renal colic concluded that both opioids and NSAIDs are able to offer efficient painkilling for a patient in acute renal colic discomfort. They further noted that opioids are concomitant with an upper manifestation of adversative occurrences, especially vomiting. Bearing in the mind the incessant vomiting concomitant with the usage
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RESEARCH PROPOSAL4 of opioid medications, especially pethidine, as well as the inordinate probability of necessitating for additional analgesia, they recommended that if it is a must to use an opioid, pethidine should not be used. 3.Methodology 3.1 Sampling The system review of this research will only involve participants or adult patients with an clinical analysis of acute renal colic who are 16 years and above. For them to be included in the list of participants these patients should have experienced the pain for less than 12 hours and its severity should range between restrained to a serious one. If an investigation disseminates data on both paediatric and adult populaces, we shall only capture the data if the average mean age of the victim is above 18. If there will be some data from mixed populations’ investigations, its outcome will be highlighted when disseminating the ultimate results. 3.2 Data Collection Two independent authors will be obliged to screen various abstracts and titles of re-replicated outcomes to figure out the hypothetically appropriate studies. The studies will then be reviewed further autonomously by skimming through the entire text to affirm the inclusion methodology. Any discrepancy shall be solved by consolations or discussions with a third reviewer writer. Agreement on autonomous insertion of abstract, full text or titles will be enumerated by use of K statistics. Explanations for eliminating hypothetically appropriate studies will be documented and described as supplementary to the central review.
RESEARCH PROPOSAL5 The authors will separately excerpt the data by use of a prepiloted Microsoft Excel sheet and Cochrane Collaboration Review Manager statistical software. Prior to commencing the evaluation, calibration exercises will be carried out amongst the assessors in order to ascertain constancy. Inconsistencies concerning the data abstraction shall be decided through discussions and coming to an agreement. Data will be gathered on various data topics which include research information, characteristics of the study subjects, and Information on comparison intervention arms. Research information will include the first researcher, the place where the research will be carried out, research design (concealed and randomization allocation), the year of publication, and the sample size. Features of the research subjects which shall be gathered include sex, age, numbers in every cluster, exclusion, and inclusion benchmarks of discrete study, discomfort notches at the time of randomization, as well as analytical affirmation of renal colic disease. Statistics on intervention and comparison arms includes the intervention and comparator(s) (dose, route, and drug), number of clusters, as well as the information concerning blinding (managing people, evaluator and victim). Facts concerning omission after randomization shall be noted down too (intent to treat). 3.3 Data Analysis Data synthesis For dichotomous results, like in excess of or equivalent to 50% decrease in discomfort, the necessity for salvage analgesia, or extreme occurrences, a risk proportion with 95% Confidence Interval shall be described. The examinations where an unremitting measurement scale will be applied to evaluate the main effects, such as the variance in mean pain score, patient-rated discomfort; a Mean Difference (MD) shall be recounted. A standardized MD
RESEARCH PROPOSAL6 will be applied to express the outcomes in cases where different measurement scales where used. In adverse effects, the risk disparity will be determined with 95% Confidence Interval (CI). Non-quantitative data and skewed data will be presented descriptively. Subgroup analysis Primary analyses on the groups of treatment such as NSAIDs versus opioids shall be performed. In addition, subgroup analyses with regard to the kinds of opioids or NSAIDs applied, ways of administration, and the eminence of the research will also be examined. The analgesic effects will be evaluated using four dissimilar outcome variables, namely: the fraction of victims with at least 50% decrease in discomfort, patient-reported discomfort reprieve by use of a Visual Analogue Scale (or VAS);pain recurrence, andneed for rescue medication. Authors' conclusions Though owing to the inconsistency in investigations (outcome variables, interventions, and inclusion criteria) as well as the quality of evidence is not of a high quality, we still acknowledge that NSAIDs are more effective when it comes to the treatment for renal colic among the adults upon comparison to opioids. 3.4 Ethical Considerations Since the study will combine both primary and secondary data sources, formal considerations will be necessary. Information gathered from various participants will be kept confidential and its use will solely be for the study purpose.
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RESEARCH PROPOSAL7 3.5 Limitations of this research Just like any systematic reviews, this study might have various limitations. We might experience a difficulty in pooling data owing to heterogeneity among the already published literature. We might also note that not all NSAIDs and opioids lead to a similar effect on renal colic. 4.Dissemination of results The findings of this research will be shared with various individuals such as learners, practitioners, participants, and professional peers. The usage of information contained in the study will depend on the individual who receives it. Practitioners can use the results to make more informed decisions, formulate, and implement strategies tailored towards the welfare of the renal colic patients(Baxter, & Jack, 2008).Learners in different high education institutions will access soft copies of the study results and use them in their academic undertakings. This information will augment their knowledge concerning the benefits of using NSAIDs as opposed to opioids(Tunis, Stryer, & Clancy, 2003).Participants who took part in the study will also obtain this information and since most of them are suffering from renal colic, they will use the content to further understand how to handle the ailment. Professional peers can make use of this study data as a reference material while conducting their research projects(Francke, 2008).
RESEARCH PROPOSAL8 References Baxter, P., & Jack, S. (2008). Qualitative case study methodology: Study design and implementation for novice researchers.The qualitative report,13(4), 544-559. Davenport, K., Timoney, A. G., & Keeley, F. X. (2005). Conventional and alternative methods for providing analgesia in renal colic.BJU international,95(3), 297-300. Francke, A. L., Smit, M. C., de Veer, A. J., & Mistiaen, P. (2008). Factors influencing the implementation of clinical guidelines for healthcare professionals: a systematic meta- review.BMC medical informatics and decision making,8(1), 38. Holdgate, A., & Pollock, T. (2004). Nonsteroidal anti‐inflammatory drugs (NSAIDS) versus opioids for acute renal colic.The Cochrane Library. Pathan, S. A., Mitra, B., & Cameron, P. A. (2017). A Systematic Review and Meta-analysis Comparing the Efficacy of Nonsteroidal Anti-inflammatory Drugs, Opioids, and Paracetamol in the Treatment of Acute Renal Colic.European Urology. Perazella, M. A. (2009). Renal vulnerability to drug toxicity.Clinical Journal of the American Society of Nephrology,4(7), 1275-1283. Pountos, I., Georgouli, T., Bird, H., & Giannoudis, P. V. (2011). Nonsteroidal anti- inflammatory drugs: prostaglandins, indications, and side effects.International Journal of Interferon, Cytokine and Mediator Research,3(1), 19-27. Snir, N., Moskovitz, B., Nativ, O., Margel, D., Sandovski, U., Sulkes, J., ... & Lifshitz, D. A. (2008). Papaverine hydrochloride for the treatment of renal colic: an old drug revisited. A prospective, randomized study.The Journal of urology,179(4), 1411- 1414.
RESEARCH PROPOSAL9 Soleimanpour, H., Hassanzadeh, K., Vaezi, H., Golzari, S. E., Esfanjani, R. M., & Soleimanpour, M. (2012). Effectiveness of intravenous lidocaine versus intravenous morphine for patients with renal colic in the emergency department.BMC urology,12(1), 13. Springhart, W. P., Marguet, C. G., Sur, R. L., Norris, R. D., Delvecchio, F. C., Young, M. D., ... & Preminger, G. M. (2006). Second Prize: Forced versus Minimal Intravenous Hydration in the Management of Acute Renal Colic: A Randomized Trial.Journal of endourology,20(10), 713-716. Tadros, N. N., Bland, L., Legg, E., Olyaei, A., & Conlin, M. J. (2013). A single dose of a non‐steroidal anti‐inflammatory drug (NSAID) prevents severe pain after ureteric stent removal: a prospective, randomised, double‐blind, placebo‐controlled trial.BJU international,111(1), 101-105. Tunis, S. R., Stryer, D. B., & Clancy, C. M. (2003). Practical clinical trials: increasing the value of clinical research for decision making in clinical and health policy.Jama,290(12), 1624-1632.
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RESEARCH PROPOSAL10 Appendix Appendix 1: Electronic search approaches Nonsteroidal anti-inflammatory drugs or NSAIDs Assessing renal colic Diagnosing renal colic Examining the patient with renal colic Examining suspected renal colic Opioids drugs Appendix 2: Recommended reading material: National Institute for Health and Care Excellence (NICE). Renal colic - acute. 2009. Available from:http://cks.nice.org.uk/renal-colic-acute#!scenario Holdgate A, Pollock T. Nonsteroidal anti-inflammatory drugs (NSAIDs) versus opioids for acute renal colic. Cochrane Database Syst Rev 2005:CD004137. Bultitude M, Rees J. Management of renal colic. BMJ 2012;345:e5499.