Open Access Protocol BMJ Open: first published as 10.1136/bmjopen-2016-015002 on 4 May 2017. Downloaded from What is the best analgesic option for patients presenting with renal colic to the emergency department? Protocol for a systematic review and meta-analysis Sameer A. Pathan,1,2,3 Biswadev Mitra,2,3,4 Lorena Romero,5 Peter A. Cameron2,3,4 To cite: Pathan SA., Mitra B, ABSTRACT Strengths and limitations of this study Romero L, et al. What is the best Introduction Patients with renal colic present to the analgesic option for patients emergency department in excruciating pain. There is presenting with renal colic to ► This is the protocol for a systematic review and variability in practice regarding the choice of initial the emergency department? meta-analysis of randomised controlled trials. analgesic to be used in renal colic. The aim of this article is Protocol for a systematic review ► We plan to follow the Preferred Reporting Items for and meta-analysis. BMJ Open to outline the protocol for review of the efficacy and safety Systematic review and Meta–Analysis Protocols, 2017;7:e015002. doi:10.1136/ of non-steroidal anti-inflammatory drugs (NSAIDs), opioids Grading of Recommendations Assessment, bmjopen-2016-015002 and paracetamol use in renal colic pain management. Development and Evaluation framework, and ► Additional material is Methods and analysis This is the protocol for a Cochrane tools for assessing the risk of bias. published online only. To view systematic review, comparing efficacy of NSAIDs, opioids We anticipate difficulty in pooling data due to please visit the journal online ► and paracetamol in renal colic studied under randomised heterogeneity among the published research. (http:// dx. doi. org/ 10. 1136/ controlled trial (RCT) design. This protocol reporting is bmjopen- 2016- 015002) ► It will provide robust evidence in deciding superiority based on the PRISMA-P recommendations (PRISMA-P- among commonly used analgesics, and help to checklist). We will conduct a comprehensive literature improve guidance for protocolised analgesia in renal Received 1 November 2016 search for both peer-reviewed and grey literature colic. Revised 6 March 2017 published until 18 December 2016. Using a predefined Accepted 21 March 2017 search strategy, MEDLINE, Embase and Cochrane Central Register of Controlled Trials will be searched. Additional searches will include WHO International millions of patient visits to emergency depart- http://bmjopen.bmj.com/ Clinical Trials Registry Platform, abstract list of relevant ments (ED) or outpatient clinics.1 2 The acute major conferences and the reference lists of relevant painful presentation is commonly known as publications. Two authors will independently screen and renal colic, and movement of stone in the identify the studies to be included. The RCT comparing NSAIDs versus opioids or paracetamol will be included urinary tract produces this excruciating pain. in the review, if the age of participants in the study was The National Health Service, England statis- >16 years and they presented with moderate to severe tics for year 2012–2013 estimated the cost renal colic. Any disagreement between the screening for renal colic at nearly £20 million, where 3 authors will be resolved through discussion and median patient stay in the hospital was 1 day. on September 26, 2021 by guest. Protected copyright. reaching consensus; if not, a third reviewer will arbitrate. In the management of renal colic, one of the 1Emergency Department, Quantitative data from homogeneous studies will be priorities in the ED is to provide quick, safe Hamad General Hospital, Hamad pooled in the meta-analysis using RevMan V.5.3 software. and effective analgesia. Medical Corporation, Doha, The findings of this review will be presented according to The most commonly prescribed anal- Qatar the guidelines in the Cochrane Handbook of Systematic gesics in renal colic are non-steroidal 2Department of Epidemiology & Reviews of Interventions and the Preferred Reporting Items anti-inflammatory drugs (NSAIDs), opioids Preventive Medicine, Monash for Systematic Review and Meta-Analysis statement. 4 5 University, Melbourne, Australia Ethics and dissemination Formal ethics approval is not and paracetamol. The important factors in 3 National Trauma Research required, as primary data will not be collected. We plan to the selection of first-line analgesia in the ED Institute, The Alfred Hospital, publish the result of this review in a peer-reviewed journal. are efficacy, safety, the ease of rapid admin- Melbourne, Australia istration, and the logistics involved. Effective 4Emergency & Trauma Centre, The Alfred Hospital, Melbourne, ongoing analgesia can be practically chal- Australia INTRODUCTION lenging to deliver in an ED with a diverse 5The Ian Potter Library, The Kidney stones are common in the ‘stone population and a high volume of patients Alfred, Melbourne, Victoria, belt’ region, which extends over America being managed concurrently.6 A previ- Australia (Southeast), Africa (North), Middle East ously published meta-analysis comparing Correspondence to Asia (Southeast), and Australia (North- NSAIDs with opioids suggested NSAIDs were 1 Dr Sameer A. Pathan; east). Globally, the lifetime prevalence of better than opioids in terms of requiring sameer. pathan@ monash. edu stone disease is 10%–15% and accounts for less rescue analgesia and having fewer side Pathan SA., et al. BMJ Open 2017;7:e015002. doi:10.1136/bmjopen-2016-015002 1 Open Access BMJ Open: first published as 10.1136/bmjopen-2016-015002 on 4 May 2017. Downloaded from effect. However, it did not establish superior efficacy of from mixed population studies will be highlighted when either drug group.5 7 Although the European Associa- reporting final results. tion of Urology guidelines on urolithiasis recommends NSAIDs as the first choice, the use of intravenous opioids Type of studies as the first-line analgesic in renal colic continues to be Only randomised controlled trials comparing NSAIDs a common practice in many developed countries.8–12 versus opioids or NSAIDs versus paracetamol will be However, the logistical delay involved in intravenous included in the review. There will be no language restric- administrations, dose-dependent side effects, need for tion to conduct primary search. If the language used to titrating dosage and overly bureaucratic restrictions are write the article is other than English, we will use a profes- some of the challenges associated with the intravenous sional translator to translate the text in English. opioid use as the first-line analgesic in the busy ED.13–15 Routine use of NSAIDs has been limited because of the Types of interventions fear of gastrointestinal (GI) and renal complications. In The studies will be reviewed if interventions include the addition, there has been undue emphasis placed on the following: possibility of abscess and muscle necrosis secondary to ► NSAIDs versus opioids in any dose, by any route in intramuscular injection, given the extremely low level of any setting, used for pain relief in acute renal colic documented cases. episode will be eligible. The obvious limitations of previous studies and system- ► NSAIDs versus paracetamol (acetaminophen) in any atic reviews may partly explain the continued clinical dose, by any route in any setting, used for pain relief orthodoxy of intravenous opioid use as the first anal- in acute renal colic episode will be eligible. gesic in many settings. First, this review was conducted NSAIDs included will be salicylates, propionic acid and published in 2004 and the studies included were 5 derivatives, acetic acid derivatives, enolic acid derivatives, published between 1982 and 1999. In the last 15 years, fenamates, selective Cox-2 inhibitors and sulfonamides. newer, well-powered, pragmatic clinical trials have been published with clinically relevant outcomes in renal colic management. Second, most studies in the review only Types of outcome measures included patients who had confirmed renal calculi on Studies with at least one of the following outcomes will subsequent testing. This may limit the applicability of be included: evidence in routine clinical practice where patients are ► outcome measured using a validated pain scale treated with a clinical picture of renal colic well before ► difference in pain score at 30 min any imaging can be performed. Third, significant hetero- ► difference in the proportion of patients with pain geneity between the studies included did not allow pooled relief at 30 min http://bmjopen.bmj.com/ analysis to test the superiority of a drug based on effi- ► need for rescue analgesia cacy.4 5 A pooled analysis of NSAIDs other than ketorolac ► adverse events as reported in the review showed a pain reduction of 4.6 mm (on ► major adverse event (eg, GI bleeding and renal visual analogue scale 0–100 mm) only, which is minimal complications, complications at the intramuscular compared with the newer trial results.15 Fourthly, 12 of injection site). the 20 included trials used pethidine as their opioid arm, which is not a commonly used opioid in current practice.5 Information sources Lastly, studies available to include at the time of review The search will not be restricted by language or date of on September 26, 2021 by guest. Protected copyright. lacked consistent reporting of serious adverse events such publication to avoid publication or retrieval biases. We as renal failure and GI bleeding, limiting comparability. will search the following