What is the best analgesic option for patients …...of renal colic well before any imaging can be...

For peer review only

Non-steroidal anti-inflammatory drugs (NSAIDS) versus opioids (update) and NSAIDS versus paracetamol in the

management of acute renal colic-Protocol for a systematic review and meta-analysis

Journal: BMJ Open

Manuscript ID bmjopen-2016-015002

Article Type: Protocol

Date Submitted by the Author: 01-Nov-2016

Complete List of Authors: Pathan, Sameer; Hamad Medical Corp, Emergency Department; Monash University School of Public Health and Preventive Medicine, Mitra, Biswadev; Monash University, Romero, Lorena ; The Ian Potter Library, Ground Floor, AMREP Building, The Alfred Cameron, Peter; Monash University, Department of Epidemiology and Preventive Medicine

Primary Subject Heading:

Emergency medicine

Secondary Subject Heading: Evidence based practice, Medical management, Urology

Keywords: Renal colic, Urolithiasis < UROLOGY, NSAIDS, Paracetamol, Opioids, Analgesia

For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml

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Non-steroidal anti-inflammatory drugs (NSAIDS) versus opioids (update) and NSAIDS

versus paracetamol in the management of acute renal colic-Protocol for a systematic

review and meta-analysis

Authors’ names and degrees

1. Dr. Sameer A. Pathan 1,2,3

MBBS, CABEM, MRCEM

2. A/Prof. Biswadev Mitra 2,3,4

MBBS, MHSM, PhD, FACEM

3. Ms. Lorena Romero 5

BA, MBIT

4. Prof. Peter A. Cameron 2,3,4

MBBS, MD, FACEM

Affiliations

1 Emergency Department, Hamad General Hospital, Hamad Medical Corporation, Doha, Qatar

2 Department of Epidemiology & Preventive Medicine, Monash University, Melbourne, Australia.

3 National Trauma Research Institute, The Alfred Hospital, Melbourne, Australia.

4 Emergency & Trauma Centre, The Alfred Hospital, Melbourne, Australia.

5 Alfred Health, The Ian Potter Library, Melbourne, Australia.

Corresponding author

Dr. Sameer A. Pathan

P.O.BOX. 50107, Mesaieed Post Office, Qatar.

Email: [email protected]

Telephone: 00974 6685 7650

Word count: Abstract- 300, Manuscript – 2224

Registration: This systematic review is registered on the PROSPERO international

prospective register of systematic reviews (PROSPERO 2016:CRD42016047559).

Amendments: Any change(s) in the protocol will be updated in the PROSPERO registry.

The amendments will be accompanied by the information regarding time, date,

description of changes, and rationally behind the changes made.

Support: This systematic review is non-funded.

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ABSTRACT

Introduction

Patients with renal colic, present to the emergency department in excruciating pain.

There is uncertainty and wide variability among the choice of initial analgesic to be used

in renal colic. The aim of this review is to assess the efficacy and safety of NSAIDS,

opioids, and paracetamol use in renal colic pain management.

Methods and analysis

This is the protocol for a systematic review, comparing efficacy of NSAIDS, opioids, and

paracetamol in renal colic studied under randomized controlled trial design. We will

conduct a comprehensive literature search for both peer-reviewed and grey literature

published until 1st

October 2016. Using a predefined search strategy MEDLINE, Embase,

Cochrane Central Register of Controlled Trials will be searched. Additional searches will

include WHO International Clinical Trials Registry Platform, abstract list of relevant

major conferences and the reference lists of relevant publications. Two authors will

independently screen and identify the studies to be included. The RCT comparing

NSAIDS versus opioids or paracetamol will be included in the review, if the age of

participants in the study was >16 years, and they presented with moderate to severe

renal colic. Any disagreement between the screening authors will be resolved through

discussion and reaching to consensus, if not, a third reviewer will arbitrate. Quantitative

data from homogenous studies will be pooled in the meta-analysis using RevMan 5.3

software. The findings of this review will be presented according to guidelines in the

Cochrane Handbook of Systematic Reviews of Interventions and PRISMA statement.

Ethics and dissemination

Formal ethics approval is not required for a systematic review. We plan to publish the

result of this review in a peer-review journal. We believe that the results of this review

will provide robust evidence in deciding superiority among commonly used analgesics,

and help to improve guidance for protocolised analgesia in renal colic.

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INTRODUCTION

Kidney stones are very common in the “stone belt” region, which extends over America

(Southeast), Africa (North), Middle East, Asia (Southeast), and Australia (Northeast). 1

Globally, the lifetime prevalence of stone disease is 10-15%, and it counts for millions of

patient visits to the emergency departments (ED) or the outpatient clinics. 1 2 The acute

painful presentation is commonly known as renal colic, and movement of stone in the

urinary tract produce this excruciating pain. The National Health Service (NHS) England,

statistics for year 2012-13, estimated the cost for renal colic was nearly £20 million,

where median patient stay in the hospital was 1 day. 3 In the management of renal colic,

one of the priorities in the ED is to provide quick, safe and effective analgesia to the

patients.

The most commonly prescribed analgesics in renal colic are non-steroidal anti-

inflammatory drugs (NSAIDS), opioids and paracetamol.4 5

The important factors in the

selection of first-line analgesic in ED are efficacy, safety, the ease and rapid

administration, and the logistics involved around it. Effective ongoing analgesia can be

practically challenging to deliver in an ED with a diverse population, and a high volume

of patients being managed concurrently.6 The previously published meta-analysis

comparing NSAIDS with opioids suggested NSAIDS to be better than opioids in terms of

requiring lesser rescue analgesia and having fewer side effect. However, it did not

establish superior efficacy of either drug group.5 7

The use of intravenous opioids, as the

first-line analgesic in renal colic, continues to be a common practice in many developed

countries. However, the logistical delay involved in intravenous administrations, dose-

dependent side-effects, need for titrating dosage, and overly bureaucratic restrictions

are some of the challenges associated with the IV opioid use as the first-line analgesic in

the busy ED. 8 9

10

Routine use of NSAIDS has been limited because of the fear of

gastrointestinal (GI) and renal complications. In addition, there has been undue

emphasis placed on the possibility of abscess and muscle necrosis secondary to

intramuscular injection, given the extremely low level of documented cases.

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The obvious limitations of previous studies and systematic reviews may partly explain

the continued clinical orthodoxy of intravenous opioid use as the first analgesic in many

settings. Firstly, this review was conducted and published in 2004 and the studies

included were published between 1982-1999. 5

In the last 15 years, newer, well

powered, pragmatic, clinical trials have been published with clinically relevant outcomes

in renal colic management. Secondly, most studies in the review only included patients

who had confirmed renal calculi on subsequent testing. This may limit the applicability

of evidence in routine clinical practice where patients are treated with a clinical picture

of renal colic well before any imaging can be performed. Thirdly, significant

heterogeneity between the studies included, did not allow pooled analysis to conclude

the superiority of a drug based on efficacy. 4 5

A pooled analysis of NSAIDS other than

Ketorolac in the review showed pain reduction of 4.6mm (on VAS 0-100) only, which is

minimal compared to the newer trial results.11

Fourthly, as 12 of the 20 included trials

used pethidine as their opioid arm, which is not a commonly used opioid in current

practice. 5

Lastly, studies available to include at the time of review lacked consistent

reporting of serious adverse events such as renal failure and GI bleeding limiting

comparability.

There is ongoing controversy regarding the superiority of any of the commonly used

analgesics in terms of efficacy, optimum dosing and route of administration. Therefore,

we aim to examine the efficacy and safety of NSAIDS, opioids, and paracetamol use in

renal colic pain management.

METHODS AND DESIGN

Types of participants

The systematic review will only include studies involving adult patients (age >16 years),

with a clinical diagnosis of acute renal colic (pain less than 12 hours), and moderate to

severe pain severity. If a study reports data on both adult and pediatric population, we

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will only include the data if the mean age of patients is over 18. The data from mixed

population studies will be highlighted when reporting final results.

Type of studies

Only randomized controlled trials (RCT) comparing NSAIDS versus opioids or NSAIDS

versus paracetamol, will be included in the review. There will be no language restriction

to conduct primary search. If the language used to write the article is other than English,

we will use Google translator to translate the text.

Types of interventions

The studies will be reviewed if interventions include:

� NSAIDS versus opioids in any dose, by any route in any setting, used for pain relief in

acute renal colic episode will be eligible.

� NSAIDS versus paracetamol (acetaminophen) in any dose, by any route in any

setting, used for pain relief in acute renal colic episode will be eligible.

NSAIDS included will be salicylates, propionic acid derivatives, acetic acid derivatives,

enolic acid derivatives, fenamates, selective COX-2 inhibitors, and sulfonamides.

Types of outcome measures

Studies with at least one of the following outcomes will be included.

• Outcome measures using a validated pain scale

• Difference in pain score at 30 minutes

• Difference in the proportion of patients with pain relief at 30 minutes

• Time to pain relief

• Need for rescue analgesia

• Pain recurrence

• Major adverse event (e.g. GI bleeding and renal complications, complications at the

IM injection site)

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Information sources

The search will not be restricted by language or date of publication to avoid publication

or retrieval biases. We will search the following databases and sources for relevant

studies:

� Cochrane Central Register of Controlled Trials (CENTRAL)

� Cochrane Renal Group Specialised Register for randomized controlled trials

� Ovid MEDLINE(R) 1946 to Present with Daily Update

� Ovid MEDLINE(R) In-Process & Other Non-Indexed Citations

� Ovid MEDLINE (R) Epub Ahead of Print

� Embase Classic+ Embase 1947 to 2016 September

� WHO International Clinical Trials Registry Platform (http://apps.who.int/trialsearch/)

� Reference lists of nephrology, urology and emergency medicine textbooks,

previously published review articles, and relevant trials.

� Abstract list of the major nephrology, urology and emergency medicine conferences.

� Correspondence documents seeking information about unpublished or incomplete

trials from the investigators known to be involved in previous trials.

The initial search strategy was developed in the Ovid MEDLINE database, using subject

heading and using free-text words. The relevant sub-classes of NSAIDS and commercial

names for the commonly used drugs were searched through Google and used in the

free-text search. We also compared the search strategies used for the previous two

Cochrane reviews4 5

, and modified our strategy if any important terms were found

missing. Drugs such as Phenylbutazone, Aminophenazone (or aminopyrine), Ampyrone,

were excluded as these drugs have risk of agranulocytocis, and they are no longer used

as routine analgesics.

Search strategy

We will perform the first search on MEDLINE, Embase, and Cochrane CENTRAL via Ovid.

The detailed search strategy is attached as Appendix-A. The second search will be

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performed for ongoing clinical trials on WHO international clinical trial registry platform.

Finally, a manual search will be conducted in relevant key journals, conference

abstracts, textbook chapters, and the bibliography of included articles. Outcome of

each database search will be individually imported into Endnote X7 (Thomson Reuters)

reference manager. After this, using Endnote, the references will be combined and

duplications will be removed. The record of total search results retrieved and screened

will be kept and reported using PRISMA guidelines.

Selection process

Two authors will independently screen the titles and abstracts of de-duplicated results

to identify potentially eligible studies. These studies then will be further reviewed

independently, going through the full text, to confirm the inclusion criteria. Any

disagreement will be resolved through discussion or by consulting a third review author.

Agreement on independent inclusion of titles, abstract or full text will be quantified

using K statistics. Reasons for excluding potentially eligible studies will be recorded and

reported as supplementary to the main review.

Data collection process

Two authors will independently extract the data using Cochrane Collaboration Review

Manager statistical software (RevMan 5.3) (http://ims.cochrane.org/RevMan) and a pre-

piloted Microsoft excel sheet. Before starting the review calibration exercises will be

conducted among the reviewers to ensure consistency. Discrepancies between the data

extraction will be resolved by discussion and reaching a consensus. If needed a third

reviewer will be contacted to reach a decision.

Data items

Data will be collected on the following data points.

1. Research information: the first author, the site where study was conducted, year

of publication, research design (randomization and concealed allocation) and the

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sample size.

2. Characteristics of the study subjects: Age, sex, numbers in each group, inclusion

and exclusion of criteria of individual study, pain scores at the time of randomization,

diagnostic confirmation of renal colic.

3. Information on intervention and comparison arms: number of groups,

intervention and comparator(s) (drug, dose, and route), and the information about

blinding (treating person, assessor, and patient). Also information about exclusion after

randomization will also be recorded (intention to treat).

Outcomes and prioritization

Definition used for the primary outcome, measuring tool used, change in pain scores,

need for rescue analgesia and at what time, side effects and follow up (GI bleed or renal

impairment). Notes important but not classified in the above category will be entered as

a free text.

Quality assessment of studies

To assess the risk of bias, study data will be extracted using the Cochrane Collaboration

tool for assessing the risk of bias (Table 8.5.a in the Cochrane Handbook for Systematic

Reviews of Interventions). This includes information gathering on method of

randomization, allocation concealment, blinding of participants and investigators,

blinding of the assessor, incomplete outcome data, and other bias if any. Each domain

will be rated as having low, unclear or high risk of bias.

Missing data

We will try to contact corresponding authors to request missing data if contacts are

available. If this is not achieved, we will try to impute the missing information based on

the information available in the manuscript or the protocol of the study. For continuous

measures, missing standard deviation (SD) will be imputed from available information

such as standard error (SE), confidence interval (CI), or p-values. For a dichotomous

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outcome, proportion or percentages will be used to calculate the number of

events/people assessed for that outcome. The results will be interpreted considering

the impact of missing data.

ANALYSIS

Data synthesis

For dichotomous outcomes, such as more than or equal to 50% reduction in pain, need

for rescue analgesia, recurrence of pain, or adverse events, a risk ratio (RR) with 95%

confidence intervals (95% CI) will be reported. The studies where continuous scale of

measure were used to assess the primary effect, such as patient rated pain, difference

in mean pain score, time to pain relief, a mean difference (MD) will be reported. If

different measure scales were used, a standardized mean difference will be used to

express the results. For the adverse effects we will calculate the risk difference (RD) with

95% CI. Skewed data and non-quantitative data will be presented descriptively.

Quantitative data will be pooled in the meta-analysis using RevMan 5.3 software. Fixed

effect model or random effect model will be used appropriately based on the

heterogeneity observed among the studies included in the pooled analysis. Statistical

heterogeneity in each model will be assessed using the χ² test of heterogeneity and

quantified using the Higgins’ I2 statistics. If the heterogeneity is insignificant the Mantel-

Haenszel method will be used for the fixed effect model. We will use the random effects

model if significant statistical heterogeneity (I2 >=50% or P <0.1) is present.

Subgroup analysis

We intend to perform the primary analysis based on the treatment groups such as

NSAIDS vs opioids and NSAIDS vs paracetamol. We will also perform subgroup analysis

based on the types of opioids or NSAIDS used, routes of administration, and based on

the quality of the study. If heterogeneity is substantial, we will not perform a meta-

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analysis; a narrative, qualitative summary will be done and the information will be

presented using text and tables.

Meta-bias(es)

To assess reporting bias amongst the included studies, where possible, we will

determine if there was any deviation from the published protocol or information

registered prior to conduct of the study. If a study was published after July 1st

2005, we

will screen the Clinical Trial Register at the International Clinical Trials Registry Platform

of the World Health Organisation (http://apps.who.int/ trialssearch). To assess the

possibility of publication bias, we also plan to use a Funnel plot if 10 or more studies are

available for the meta-analysis.

Assessing cumulative evidence

We will assess the quality of body of evidence for each outcome according to Grading

of Recommendations Assessment, Development and Evaluation (GRADE) working group

methodology.

DISCUSSION

Renal colic is a common cause of ED presentations and the excruciating pain demands

effective analgesia to be administered in the shortest possible time. To minimize the

delay in rapid administration of effective and safe analgesia, an evidence-based protocol

is needed. Previous reviews were inconclusive in establishing superior efficacy to

support first-line analgesia. It is important to use the first-line agent that is most

effective, has the best safety profile, and is quick and easy to administer with a single

rather than titrated first dose. Given that there have been significant publications since

the last review on this topic, we believe that it is likely that improved guidance for

protocolised first-line analgesia for renal colic can be given.

Contributions: SAP is the guarantor. SAP, BM and PAC drafted protocol for the

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systematic review. SAP and LR developed the search strategy. All authors contributed to

the development of the selection criteria, the risk of bias assessment strategy and data

extraction criteria. All authors read, provided feedback and approved the final

manuscript.

Competing interest: We have read and understood BMJ policy on declaration of

interests and declare that we have no competing interests.

REFERENCES

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2. Ghani KR, Roghmann F, Sammon JD, et al. Emergency department visits in the

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symptomatic ureteric stones in hospitalised adults: a multicentre, placebo-

controlled, randomised controlled trial and cost-effectiveness analysis of a

calcium channel blocker (nifedipine) and an alpha-blocker (tamsulosin) (the

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4. Afshar K, Jafari S, Marks AJ, et al. Nonsteroidal anti-inflammatory drugs (NSAIDs)

and non-opioids for acute renal colic. The Cochrane database of systematic

reviews 2015;6:Cd006027. doi: 10.1002/14651858.CD006027.pub2

[published Online First: 2015/06/30]

5. Holdgate A, Pollock T. Nonsteroidal anti-inflammatory drugs (NSAIDs) versus

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6. Pines JM, Hollander JE. Emergency department crowding is associated with poor

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7. Labrecque M, Dostaler LP, Rousselle R, et al. Efficacy of nonsteroidal anti-

inflammatory drugs in the treatment of acute renal colic. A meta-analysis.

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10. Pathan SA, Mitra B, Cameron PA. Titrated doses are optimal for opioids in pain

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doi: 10.1016/s0140-6736(16)31494-5 [published Online First: 2016/09/07]

11. Pathan SA, Mitra B, Straney LD, et al. Delivering safe and effective analgesia for

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Appendix A

Ovid MEDLINE(R) 1946 to Present with Daily Update+ In-Process & Other Non-

Indexed Citations (2016 Month, Date)

# Search Statement Annotation

1

exp Urinary Bladder Calculi/ or exp Urinary Calculi/ or exp Kidney Calculi/ or exp Ureteral Calculi/ or exp Urolithiasis/ or exp Nephrolithiasis/ or exp Renal Colic/ or exp Ureteral Diseases/ or exp Ureteral Obstruction/ or exp Kidney Diseases/

2 ((Urin* or renal or kidney or ureter* or bladder) adj3 (stone* or calcul* or colic* or lith* or obstruct* or occlusi*)).mp.

3 ((Kidney or ureter*) adj2 diseas*).mp.

4 (Urolith* or nephrolith*).mp.

5 or/1-4 Population- Renal colic

6 exp Anti-Inflammatory Agents, Non-Steroidal/ or exp Cyclooxygenase Inhibitors/ or exp Cyclooxygenase 2 Inhibitors/

7

((Nonsteroidal adj2 antiinflammatory) or (Non-steroidal adj2 antiinflammatory) or (Nonsteroidal adj2 anti-inflammatory) or (Non-steroidal adj2 anti-inflammatory)).mp.

8

exp diclofenac/ or exp ketorolac/ or exp apazone/ or exp aspirin/ or exp ibuprofen/ or exp ketoprofen/ or exp Salicylates/ or exp etodolac/ or exp naproxen/ or exp indomethacin/ or exp piroxicam/ or exp celecoxib/ or exp fenoprofen/ or exp sulindac/ or exp tolmetin/ or exp mesalazine/ or exp aminosalicylic acid/

9 NSAID*.mp.

10 (Diclofenac or adiflam or agile or diclonac or dicol or diclonat* or feloran or voltarol or Voltaren or Cataflam or Voltaren-XR or Zipsor).mp.

11 (Aceclofenac or Hifenac or Cincofen or Nacsiv or Acenac).mp.

12 (Ketorolac or toradol or torolac or kealc or kenalfin or ketlac).mp.

13 (Apazon* or Azapropazon* or cinnopropazon*).mp.

14 (Aspirin* or acetylsal* or dispril or easprin* or salicylic*).mp.

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(Ibuprofen or brufen or nuprin or rufen or salprofen or dolgit or salprofen or advil* or motrin or nurofen or actiprofen or addaprin or aktren or anadin or bugesic or ibuprox).mp.

16 (ketoprofen or orudis or oruvail or ketoflam or oruvail or fastum or ketonal or ketodol or knavon or actron or ketoprofeno).mp.

17 (Dexketoprofen or keral or enantyum or ketesgel or dolmen).mp.

18 (Naproxen or naprosyn or naprosin or proxen or synflex or Aleve or Anaprox or Apronax or Naprelan).mp.

19 (etodolac or ramodar or ultradol or etova or dualgan or etodin or etopan or flancox or proxym or etodine or dolarit).mp.

20 (Indomethacin* or indocid or indocin or indomet or indometacin or metindol or osmosin).mp.

21 (Piroxicam or feldene or dolocare or dolonex or ketolin).mp.

22 (Meloxicam or mobic or vivlodex).mp.

23 (Tenoxicam or mobiflex).mp.

24 (celecoxib or celebrex or celebra).mp.

25 (rofecoxib or vioxx or ceoxx or ceeoxx).mp.

26 (valdecoxib or bextra).mp.

27 (Nimesulid* or aulin or mesulid or nimalox or sulid* or sintalgin or nimsid* or nise or nimulid).mp.

28 (Meclofenamic or meclofenamat* or meclomen).mp.

29 (fenoprofen or fenopron).mp.

30 (oxaprozin or oxaprozinum or daypro or dayrun or duraprox).mp.

31 (sulindac or cinoril or imbaral).mp.

32 (tolmetin or tolectin).mp.

33

(flurbiprofen* or sulindac* or mesalazin* or sulfasalazin* or flufenamic* or tolmetin* or fenoprofen* or diflunisal* or niflumic* or ketorolac or trometamol* or parecoxib* or teriflunomid* or benoxaprofen* or suprofen* or fenbufen* or mebron* or mepirizole* or mepyrizole* or methopyrimazole* or Epirizolum* or Polihexanid* or Dalex* or Miton* or epirizol* or clonixin* or tolemetin* or nabumeton*).mp.

34 or/6-33 NSAIDS

35 exp Analgesics, opioid/ or exp alkaloids, opiate/ or exp narcotics/

36 opioid*.mp.

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exp hydrocodone/ or exp dextropropoxyphene/ or exp fentanyl/ or exp meperidine/ or exp methadone/ or exp Morphine/ or exp Morphine Derivatives/ or exp oxymorphone/ or exp pentazocine/ or exp tramadol/

38 exp alfentanil/ or alfentanil*.mp.

39 exp codeine/ or codein*.mp.

40 (hydrocodon* or vicodin* or norco or lortab or zohydro).mp.

41 exp oxycodone/ or oxycodon*.mp.

42 (dextropropoxyphen* or darvon or darvocet or digesic or capadex).mp.

43 exp dihydromorphine/ or dihydromorphin*.mp.

44 (fentanyl or actiq or duragesic or fentora or sublimaz* or fenta).mp.

45 (meperidin* or demerol or pethidin*).mp.

46 (methadon* or dolophin* or methadose or amidon* or symoron or physephton* or heptadon).mp.

47 (morphin* or oramorph or morphia or duramorph or contin or mscontin or sevredol or zomorphzomo).mp.

48 (oxymorphon* or numorphan or opana or morphon).mp.

49 (pentazocin* or fortal or sosegon or talwin or fortwin or talacen).mp.

50 (tramadol or ultram).mp.

51 or/35-50 Opioids

52 exp Acetaminophen/

53

(abenol* or acamol* or acenol* or acephen* or acet suppositories* or acetalgin* or acetamino phenol* or acetaminophen* or acetaminophene* or acetaminophenol* or acetamol* or acetomenophen* or acetylaminophenol* or adorem* or afebrin* or algiafin* or algotropyl* or alphagesic* or alvedon* or amadil* or anacin 3* or anaflon* or analgiser* or apamide* or apirex* or arthralgen* or benuron* or biogesic* or calapol* or calodol* or dafalgan* or depyretin* or dirox* or dolex* or dolofen* or dolomol* or calpol* or eneril* or meforagesic* or dolorol* or metagesic* or napamol* or naprex* or pacemol* or pacimol* or duorol* or pamol* or panadol* or panamax* or panodil* or paracet* or paracetamole* or parageniol* or paragin* or paralen* or paralief* or paramax* or paramidol* or paximol* or paratabs* or perfalgan* or pyrigesic* or setamol* or tylenol* or tylex* or valadol* or winadol* or zydinol).mp.

54 or/52-53 Paracetamol

55 5 and 34 and 51 NSAIDS Vs Opioids

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56 5 and 34 and 54 NSAIDS Vs Paracetamol

57 randomized controlled trial.pt.

58 controlled clinical trial.pt.

59 (random$ or placebo$ or single blind$ or double blind$ or triple blind$).ti,ab.

60 (retraction of publication or retracted publication).pt.

61 or/57-60 RCTs

62 (animals not humans).sh.

63 ((comment or editorial or meta-analysis or practice-guideline or review or letter or journal correspondence) not "randomized controlled trial").pt.

64 (random sampl$ or random digit$ or random effect$ or random survey or random regression).ti,ab. not "randomized controlled trial".pt.

65 or/62-64 non-human subject or non RCTs

66 61 not 65 Human subject RCTs

67 55 and 66 NSAIDS Vs Opioids +Human subject RCTs

68 56 and 66 NSAIDS Vs Paracetamol+Human subject RCTs

69 67 or 68 NSAIDS (Opioids or paracetamol) in human subject RCTs

Embase Classic+Embase 1947 to 2016 Month, Date

# Search Statement Annotation

1 exp kidney pain/ or exp kidney colic/ or exp bladder stone/ or exp ureter stone/ or exp urolithiasis/ or exp nephrolithiasis/ or exp ureter obstruction/

2 ((Urin* or renal or kidney or ureter* or bladder) adj3 (stone* or calcul* or colic* or lith* or obstruct* or occlusi*)).mp.

3 ((Kidney or ureter*) adj2 diseas*).mp.

4 (Urolith* or nephrolith*).mp.

5 or/1-4

Population- Renal colic

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6

exp nonsteroid antiinflammatory agent/ or exp cyclooxygenase 2 inhibitor/ or exp indometacin/ or exp piroxicam/ or exp acetylsalicylic acid/ or exp celecoxib/ or exp diclofenac/ or exp ibuprofen/ or exp naproxen/ or exp azapropazone/ or exp acetylsalicylic acid/ or exp ketoprofen/ or exp salicylic acid/ or exp ketorolac/ or exp ketoprofen/ or exp salicylic acid derivative/ or exp etodolac/ or exp fenoprofen/ or exp sulindac/ or exp tolmetin/ or exp mesalazine/ or exp aminosalicylic acid/

7 ((Nonsteroidal adj2 antiinflammatory) or (Non-steroidal adj2 antiinflammatory) or (Nonsteroidal adj2 anti-inflammatory) or (Non-steroidal adj2 anti-inflammatory)).mp.

8 NSAID*.mp.

9 (Diclofenac or adiflam or agile or diclonac or dicol or diclonat* or feloran or voltarol or Voltaren or Cataflam or Voltaren-XR or Zipsor).mp.

10 (Aceclofenac or Hifenac or Cincofen or Nacsiv or Acenac).mp.

11 (Ketorolac or toradol or torolac or kealc or kenalfin or ketlac).mp.

12 (Apazon* or Azapropazon* or cinnopropazon*).mp.

13 (Aspirin* or acetylsal or dispril or easprin* or salicylic*).mp.

14 (Ibuprofen or brufen or nuprin or rufen or salprofen or dolgit or salprofen or advil* or motrin or nurofen or actiprofen or addaprin or aktren or anadin or bugesic or ibuprox).mp.

15 (ketoprofen or orudis or oruvail or ketoflam or oruvail or fastum or ketonal or ketodol or knavon or actron or ketoprofeno).mp.

16 (Dexketoprofen or keral or enantyum or ketesgel or dolmen).mp.

17 (Naproxen or naprosyn or naprosin or proxen or synflex or Aleve or Anaprox or Apronax or Naprelan).mp.

18 (etodolac or ramodar or ultradol or etova or dualgan or etodin or etopan or flancox or proxym or etodine or dolarit).mp.

19 (Indomethacin* or indocid or indocin or indomet or indometacin or metindol or osmosin).mp.

20 (Piroxicam or feldene or dolocare or dolonex or ketolin).mp.

21 (Meloxicam or mobic or vivlodex).mp.

22 (Tenoxicam or mobiflex).mp.

23 (celecoxib or celebrex or celebra).mp.

24 (rofecoxib or vioxx or ceoxx or ceeoxx).mp.

25 (valdecoxib or bextra).mp.

26 (Nimesulid* or aulin or mesulid or nimalox or sulid* or sintalgin or nimsid* or nise or nimulid).mp.

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27 (Meclofenamic or meclofenamat* or meclomen).mp.

28 (fenoprofen or fenopron).mp.

29 (oxaprozin or oxaprozinum or daypro or dayrun or duraprox).mp.

30 (sulindac or cinoril or imbaral).mp.

31 (tolmetin or tolectin).mp.

32

(flurbiprofen* or sulindac* or mesalazin* or sulfasalazin* or flufenamic* or tolmetin* or fenoprofen* or diflunisal* or niflumic* or ketorolac or trometamol* or parecoxib* or teriflunomid* or benoxaprofen* or suprofen* or fenbufen* or mebron* or mepirizole* or mepyrizole* or methopyrimazole* or Epirizolum* or Polihexanid* or Dalex* or Miton* or epirizol* or clonixin* or tolemetin* or nabumeton*).mp.

33 or/6-32 NSAIDS

34 exp opiate/ or exp narcotic analgesic agent/ or exp opiate agonist/

35 exp hydrocodone/ or exp dextropropoxyphene/ or exp fentanyl/ or exp pethidine/ or exp methadone/ or exp oxymorphone/ or exp pentazocine/ or exp tramadol/

36 opioid*.mp.

37 exp alfentanil/ or alfentanil*.mp.

38 exp codeine/ or codein*.mp.

39 (hydrocodon* or vicodin* or norco or lortab or zohydro).mp.

40 exp oxycodone/ or oxycodon*.mp.

41 (dextropropoxyphen* or darvon or darvocet or digesic or capadex).mp.

42 exp dihydromorphine/ or dihydromorphin*.mp.

43 (fentanyl or actiq or duragesic or fentora or sublimaz* or fenta).mp.

44 (meperidin* or demerol or pethidin*).mp.

45 (methadon* or dolophin* or methadose or amidon* or symoron or physephton* or heptadon).mp.

46 exp morphine/ or exp morphine derivative/

47 (morphin* or oramorph or morphia or duramorph or contin or mscontin or sevredol or zomorphzomo).mp.

48 (oxymorphon* or numorphan or opana or morphon).mp.

49 (pentazocin* or fortal or sosegon or talwin or fortwin or talacen).mp.

50 (tramadol or ultram).mp.

51 or/34-50 Opioids

52 exp paracetamol/

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53

(abenol* or acamol* or acenol* or acephen* or acet suppositories* or acetalgin* or acetamino phenol* or acetaminophen* or acetaminophene* or acetaminophenol* or acetamol* or acetomenophen* or acetylaminophenol* or adorem* or afebrin* or algiafin* or algotropyl* or alphagesic* or alvedon* or amadil* or anacin 3* or anaflon* or analgiser* or apamide* or apirex* or arthralgen* or benuron* or biogesic* or calapol* or calodol* or dafalgan* or depyretin* or dirox* or dolex* or dolofen* or dolomol* or calpol* or eneril* or meforagesic* or dolorol* or metagesic* or napamol* or naprex* or pacemol* or pacimol* or duorol* or pamol* or panadol* or panamax* or panodil* or paracet* or paracetamole* or parageniol* or paragin* or paralen* or paralief* or paramax* or paramidol* or paximol* or paratabs* or perfalgan* or pyrigesic* or setamol* or tylenol* or tylex* or valadol* or winadol* or zydinol).mp.

54 or/52-53 Paracetamol

55 5 and 33 and 51 NSAIDS Vs Opioids

56 5 and 33 and 54

NSAIDS Vs Paracetamol

57 (random$ or placebo$ or single blind$ or double blind$ or triple blind$).ti,ab.

58 RETRACTED ARTICLE/

59 or/57-58 RCTs

60 (animal$ not human$).sh,hw.

61 (book or conference paper or editorial or letter or review).pt. not exp randomized controlled trial/

62 (random sampl$ or random digit$ or random effect$ or random survey or random regression).ti,ab. not exp randomized controlled trial/

63 or/60-62

non-human subject or non RCTs

64 59 not 63 Human subject RCTs

65 55 and 64

NSAIDS Vs Opioids +Human subject RCTs

66

56 and 64

NSAIDS Vs Paracetamol +Human subject RCTs

67

65 or 66

NSAIDS (Opioids or paracetamol) in human subject RCTs

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PRISMA-P (Preferred Reporting Items for Systematic review and Meta-Analysis Protocols) 2015 checklist: recommended items to

address in a systematic review protocol*

Section and topic Item

No

Checklist item (Page No.#)

ADMINISTRATIVE INFORMATION

Title:

Identification 1a Identify the report as a protocol of a systematic review 1

Update 1b If the protocol is for an update of a previous systematic review, identify as such 1

Registration 2 If registered, provide the name of the registry (such as PROSPERO) and registration number 1

Authors:

Contact 3a Provide name, institutional affiliation, e-mail address of all protocol authors; provide physical mailing address of corresponding

author

1

Contributions 3b Describe contributions of protocol authors and identify the guarantor of the review 10

Amendments 4 If the protocol represents an amendment of a previously completed or published protocol, identify as such and list changes;

otherwise, state plan for documenting important protocol amendments

1

Support:

Sources 5a Indicate sources of financial or other support for the review 1

Sponsor 5b Provide name for the review funder and/or sponsor

Role of sponsor

or funder

5c Describe roles of funder(s), sponsor(s), and/or institution(s), if any, in developing the protocol

INTRODUCTION

Rationale 6 Describe the rationale for the review in the context of what is already known 3

Objectives 7 Provide an explicit statement of the question(s) the review will address with reference to participants, interventions,

comparators, and outcomes (PICO)

4

METHODS

Eligibility criteria 8 Specify the study characteristics (such as PICO, study design, setting, time frame) and report characteristics (such as years

considered, language, publication status) to be used as criteria for eligibility for the review

4-5

Information sources 9 Describe all intended information sources (such as electronic databases, contact with study authors, trial registers or other grey

literature sources) with planned dates of coverage

6

Search strategy 10 Present draft of search strategy to be used for at least one electronic database, including planned limits, such that it could be

repeated

6 and

Appendix-A

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Study records:

Data

management

11a Describe the mechanism(s) that will be used to manage records and data throughout the review 7

Selection

process

11b State the process that will be used for selecting studies (such as two independent reviewers) through each phase of the review

(that is, screening, eligibility and inclusion in meta-analysis)

7

Data collection

process

11c Describe planned method of extracting data from reports (such as piloting forms, done independently, in duplicate), any

processes for obtaining and confirming data from investigators

7

Data items 12 List and define all variables for which data will be sought (such as PICO items, funding sources), any pre-planned data

assumptions and simplifications

7

Outcomes and

prioritization

13 List and define all outcomes for which data will be sought, including prioritization of main and additional outcomes, with

rationale

8

Risk of bias in

individual studies

14 Describe anticipated methods for assessing risk of bias of individual studies, including whether this will be done at the outcome

or study level, or both; state how this information will be used in data synthesis

8

Data synthesis 15a Describe criteria under which study data will be quantitatively synthesised 9

15b If data are appropriate for quantitative synthesis, describe planned summary measures, methods of handling data and methods of

combining data from studies, including any planned exploration of consistency (such as I2, Kendall’s τ)

15c Describe any proposed additional analyses (such as sensitivity or subgroup analyses, meta-regression)

15d If quantitative synthesis is not appropriate, describe the type of summary planned

Meta-bias(es) 16 Specify any planned assessment of meta-bias(es) (such as publication bias across studies, selective reporting within studies) 10

Confidence in

cumulative evidence

17 Describe how the strength of the body of evidence will be assessed (such as GRADE) 10

* It is strongly recommended that this checklist be read in conjunction with the PRISMA-P Explanation and Elaboration (cite when available) for important

clarification on the items. Amendments to a review protocol should be tracked and dated. The copyright for PRISMA-P (including checklist) is held by the

PRISMA-P Group and is distributed under a Creative Commons Attribution Licence 4.0.

From: Shamseer L, Moher D, Clarke M, Ghersi D, Liberati A, Petticrew M, Shekelle P, Stewart L, PRISMA-P Group. Preferred reporting items for systematic review and

meta-analysis protocols (PRISMA-P) 2015: elaboration and explanation. BMJ. 2015 Jan 2;349(jan02 1):g7647.

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Analgesic options for management of acute renal colic- Protocol for a systematic review and meta-analysis.

Journal: BMJ Open

Manuscript ID bmjopen-2016-015002.R1


Date Submitted by the Author: 08-Feb-2017

Complete List of Authors: Pathan, Sameer; Hamad Medical Corp, Emergency Department; Monash University School of Public Health and Preventive Medicine, Mitra, Biswadev; Monash University, Romero, Lorena ; The Ian Potter Library, Ground Floor, AMREP Building, The Alfred Cameron, Peter; Monash University, Department of Epidemiology and Preventive Medicine

Primary Subject

Heading: Emergency medicine

Secondary Subject Heading: Evidence based practice, Medical management, Urology, Research methods





jopen.bmj.com

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1

Analgesic options for management of acute renal colic- Protocol for a systematic

review and meta-analysis



MBBS, CABEM, MRCEM




BA, MBIT


MBBS, MD, FACEM

Affiliations










Telephone: 00974 6685 7650








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2

ABSTRACT

Introduction


There is variability in practice regarding the choice of initial analgesic to be used in renal

colic. The aim of this article is to outline the protocol for review of the efficacy and

safety of NSAIDS, opioids, and paracetamol use in renal colic pain management.





published until 1st









discussion and reaching consensus, if not, a third reviewer will arbitrate. Quantitative





Formal ethics approval is not required, as primary data will not be collected. We plan to

publish the result of this review in a peer-reviewed journal.

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3

Strengths and limitations of this study

• Systematic review and meta-analysis of randomised controlled trials

• We plan to follow the Preferred Reporting Items for Systematic review and

Meta-Analysis Protocols (PRISMA-P), Grading of Recommendations Assessment,

Development and Evaluation (GRADE) framework and COCHRANE tools for

assessing the risk of bias.

• We anticipate difficulty in pooling data due to heterogeneity among the

published research.

• It will provide robust evidence in deciding superiority among commonly used

analgesics, and help to improve guidance for protocolised analgesia in renal

colic.

INTRODUCTION

Kidney stones are common in the “stone belt” region, which extends over America


Globally, the lifetime prevalence of stone disease is 10-15%, and accounts for millions of

patient visits to emergency departments (ED) or the outpatient clinics. 1

2 The acute


urinary tract produces this excruciating pain. The National Health Service (NHS),

England statistics for year 2012-13, estimated the cost for renal colic was nearly £20

million, where median patient stay in the hospital was 1 day. 3 In the management of

renal colic, one of the priorities in the ED is to provide quick, safe and effective

analgesia.




selection of first-line analgesia in the ED are efficacy, safety, the ease of rapid

administration and logistics involved. Effective ongoing analgesia can be practically

challenging to deliver in an ED with a diverse population, and a high volume of patients

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4

being managed concurrently.6 A previously published meta-analysis comparing NSAIDS

with opioids suggested NSAIDS were better than opioids in terms of requiring less

rescue analgesia and having fewer side effect. However, it did not establish superior

efficacy of either drug group.5 7

The use of intravenous opioids, as the first-line analgesic

in renal colic, continues to be a common practice in many developed countries.8-11

However, the logistical delay involved in intravenous administrations, dose-dependent

side-effects, need for titrating dosage, and overly bureaucratic restrictions are some of

the challenges associated with the IV opioid use as the first-line analgesic in the busy ED.

12 13

14 Routine use of NSAIDS has been limited because of the fear of gastrointestinal

(GI) and renal complications. In addition, there has been undue emphasis placed on the

possibility of abscess and muscle necrosis secondary to intramuscular injection, given

the extremely low level of documented cases.











heterogeneity between the studies included, did not allow pooled analysis to test the

superiority of a drug based on efficacy. 4 5




Fourthly, 12 of the 20 included trials used

pethidine as their opioid arm, which is not a commonly used opioid in current practice. 5

Lastly, studies available to include at the time of review lacked consistent reporting of

serious adverse events such as renal failure and GI bleeding limiting comparability.

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5





METHODS AND DESIGN




severe pain severity. If a study reports data on both adult and pediatric populations, we



Type of studies




we will use a professional translator to translate the text in English.









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6








• Pain recurrence


IM injection site)

Information sources



studies:














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7




Cochrane reviews4 5



were excluded as these drugs have a risk of agranulocytocis, and are no longer used as

routine analgesics.

Search strategy










Selection process









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8







Data items




sample size.









To compare outcomes, identification of the definition used for the primary outcome,

measuring tool used, change in pain scores, need for rescue analgesia and at what time,

side effects and follow up (GI bleed or renal impairment), will be assessed. Notes

important but not classified in the above category will be entered as a free text.




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9





Missing data









ANALYSIS

Data synthesis






different measurement scales were used, a standardized mean difference will be used

to express the results. For the adverse effects we will calculate the risk difference (RD)

with 95% CI. Skewed data and non-quantitative data will be presented descriptively.


effect models or random effect models will be used appropriately based on the

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10






Subgroup analysis







Meta-bias(es)




2005, we








methodology.

DISCUSSION

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11












publish the result of this review in a peer-reviewed journal. We believe that the results

of this review will provide robust evidence in deciding superiority among commonly

used analgesics, and help to improve guidance for protocolised analgesia in renal colic.

Contributions: SAP is the guarantor. SAP, BM and PAC drafted the protocol for the




manuscript.



REFERENCES







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12









2015/08/06]












First: 2007/10/05]




1994/06/27]

8. Dave C, Shetty S, Faraj K. Nephrolithiasis Treatment & Management: WebMD;

2016 [updated Dec 03, 2016. Available from:

http://emedicine.medscape.com/article/437096-treatment - d7 accessed

Feb 05, 2017.

9. Ketabchi AA, Ebad-Zadeh MR, Parvaresh S, et al. Opium Dependency in Recurrent

Painful Renal Lithiasis Colic. Addiction & Health 2012;4(1-2):73-8.

10. Worster A. Renal colic. In: Thomas SH, ed. Emergency Department Analgesia: An

Evidence-Based Guide. New York: Cambridge University Press 2008:359-62.

11. Bounes V, Valle B, Concina F, et al. Treatment of Acute Renal Colic in US and

French EDs: Simulated Cases and Real Cases in Acute Pain Management. The

American journal of emergency medicine 2016;34(10):1955-58. doi:

10.1016/j.ajem.2016.06.107 [published Online First: 2016/07/20]

12. Manjiani D, Paul DB, Kunnumpurath S, et al. Availability and Utilization of

Opioids for Pain Management: Global Issues. The Ochsner Journal

2014;14(2):208-15.



England) 2016;387(10028):1644-56. doi: 10.1016/s0140-6736(16)00161-6


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13




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AppendixA

OvidMEDLINE(R)1946toPresentwithDailyUpdate+In-Process&OtherNon-IndexedCitations(2016Month,Date)

# SearchStatement Annotation

1

expUrinaryBladderCalculi/orexpUrinaryCalculi/orexpKidneyCalculi/orexpUreteralCalculi/orexpUrolithiasis/orexpNephrolithiasis/orexpRenalColic/orexpUreteralDiseases/orexpUreteralObstruction/orexpKidneyDiseases/

2((Urin*orrenalorkidneyorureter*orbladder)adj3(stone*orcalcul*orcolic*orlith*orobstruct*orocclusi*)).mp.

3 ((Kidneyorureter*)adj2diseas*).mp. 4 (Urolith*ornephrolith*).mp. 5 or/1-4 Population-Renalcolic

6expAnti-InflammatoryAgents,Non-Steroidal/orexpCyclooxygenaseInhibitors/orexpCyclooxygenase2Inhibitors/

7

((Nonsteroidaladj2antiinflammatory)or(Non-steroidaladj2antiinflammatory)or(Nonsteroidaladj2anti-inflammatory)or(Non-steroidaladj2anti-inflammatory)).mp.

8

expdiclofenac/orexpketorolac/orexpapazone/orexpaspirin/orexpibuprofen/orexpketoprofen/orexpSalicylates/orexpetodolac/orexpnaproxen/orexpindomethacin/orexppiroxicam/orexpcelecoxib/orexpfenoprofen/orexpsulindac/orexptolmetin/orexpmesalazine/orexpaminosalicylicacid/

9 NSAID*.mp.

10(Diclofenacoradiflamoragileordiclonacordicolordiclonat*orfeloranorvoltarolorVoltarenorCataflamorVoltaren-XRorZipsor).mp.

11 (AceclofenacorHifenacorCincofenorNacsivorAcenac).mp.

12 (Ketorolacortoradolortorolacorkealcorkenalfinorketlac).mp.

13 (Apazon*orAzapropazon*orcinnopropazon*).mp.

14 (Aspirin*oracetylsal*ordispriloreasprin*orsalicylic*).mp.

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15

(Ibuprofenorbrufenornuprinorrufenorsalprofenordolgitorsalprofenoradvil*ormotrinornurofenoractiprofenoraddaprinoraktrenoranadinorbugesicoribuprox).mp.

16(ketoprofenororudisororuvailorketoflamororuvailorfastumorketonalorketodolorknavonoractronorketoprofeno).mp.

17 (Dexketoprofenorkeralorenantyumorketesgelordolmen).mp.

18 (NaproxenornaprosynornaprosinorproxenorsynflexorAleveorAnaproxorApronaxorNaprelan).mp.

19(etodolacorramodarorultradoloretovaordualganoretodinoretopanorflancoxorproxymoretodineordolarit).mp.

20 (Indomethacin*orindocidorindocinorindometorindometacinormetindolorosmosin).mp.

21 (Piroxicamorfeldeneordolocareordolonexorketolin).mp.

22 (Meloxicamormobicorvivlodex).mp. 23 (Tenoxicamormobiflex).mp. 24 (celecoxiborcelebrexorcelebra).mp. 25 (rofecoxiborvioxxorceoxxorceeoxx).mp. 26 (valdecoxiborbextra).mp.

27 (Nimesulid*oraulinormesulidornimaloxorsulid*orsintalginornimsid*orniseornimulid).mp.

28 (Meclofenamicormeclofenamat*ormeclomen).mp. 29 (fenoprofenorfenopron).mp.

30 (oxaprozinoroxaprozinumordayproordayrunorduraprox).mp.

31 (sulindacorcinorilorimbaral).mp. 32 (tolmetinortolectin).mp.

33

(flurbiprofen*orsulindac*ormesalazin*orsulfasalazin*orflufenamic*ortolmetin*orfenoprofen*ordiflunisal*orniflumic*orketorolacortrometamol*orparecoxib*orteriflunomid*orbenoxaprofen*orsuprofen*orfenbufen*ormebron*ormepirizole*ormepyrizole*ormethopyrimazole*orEpirizolum*orPolihexanid*orDalex*orMiton*orepirizol*orclonixin*ortolemetin*ornabumeton*).mp.

34 or/6-33 NSAIDS

35 expAnalgesics,opioid/orexpalkaloids,opiate/orexpnarcotics/

36 opioid*.mp.

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37

exphydrocodone/orexpdextropropoxyphene/orexpfentanyl/orexpmeperidine/orexpmethadone/orexpMorphine/orexpMorphineDerivatives/orexpoxymorphone/orexppentazocine/orexptramadol/

38 expalfentanil/oralfentanil*.mp. 39 expcodeine/orcodein*.mp.

40 (hydrocodon*orvicodin*ornorcoorlortaborzohydro).mp.

41 expoxycodone/oroxycodon*.mp.

42 (dextropropoxyphen*ordarvonordarvocetordigesicorcapadex).mp.

43 expdihydromorphine/ordihydromorphin*.mp.

44 (fentanyloractiqorduragesicorfentoraorsublimaz*orfenta).mp.

45 (meperidin*ordemerolorpethidin*).mp.

46 (methadon*ordolophin*ormethadoseoramidon*orsymoronorphysephton*orheptadon).mp.

47 (morphin*ororamorphormorphiaorduramorphorcontinormscontinorsevredolorzomorphzomo).mp.

48 (oxymorphon*ornumorphanoropanaormorphon).mp.

49 (pentazocin*orfortalorsosegonortalwinorfortwinortalacen).mp.

50 (tramadolorultram).mp. 51 or/35-50 Opioids52 expAcetaminophen/

53

(abenol*oracamol*oracenol*oracephen*oracetsuppositories*oracetalgin*oracetaminophenol*oracetaminophen*oracetaminophene*oracetaminophenol*oracetamol*oracetomenophen*oracetylaminophenol*oradorem*orafebrin*oralgiafin*oralgotropyl*oralphagesic*oralvedon*oramadil*oranacin3*oranaflon*oranalgiser*orapamide*orapirex*orarthralgen*orbenuron*orbiogesic*orcalapol*orcalodol*ordafalgan*ordepyretin*ordirox*ordolex*ordolofen*ordolomol*orcalpol*oreneril*ormeforagesic*ordolorol*ormetagesic*ornapamol*ornaprex*orpacemol*orpacimol*orduorol*orpamol*orpanadol*orpanamax*orpanodil*orparacet*orparacetamole*orparageniol*orparagin*orparalen*orparalief*orparamax*orparamidol*orpaximol*orparatabs*orperfalgan*orpyrigesic*orsetamol*ortylenol*ortylex*orvaladol*orwinadol*orzydinol).mp.

54 or/52-53 Paracetamol55 5and34and51 NSAIDSVsOpioids

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56 5and34and54 NSAIDSVsParacetamol57 randomizedcontrolledtrial.pt. 58 controlledclinicaltrial.pt.

59 (random$orplacebo$orsingleblind$ordoubleblind$ortripleblind$).ti,ab.

60 (retractionofpublicationorretractedpublication).pt. 61 or/57-60 RCTs62 (animalsnothumans).sh.

63((commentoreditorialormeta-analysisorpractice-guidelineorrevieworletterorjournalcorrespondence)not"randomizedcontrolledtrial").pt.

64(randomsampl$orrandomdigit$orrandomeffect$orrandomsurveyorrandomregression).ti,ab.not"randomizedcontrolledtrial".pt.

65 or/62-64 non-humansubjectornonRCTs

66 61not65 HumansubjectRCTs

67 55and66 NSAIDSVsOpioids+HumansubjectRCTs

68 56and66NSAIDSVsParacetamol+HumansubjectRCTs

69 67or68NSAIDS(Opioidsorparacetamol)inhumansubjectRCTs

EmbaseClassic+Embase1947to2016Month,Date


1expkidneypain/orexpkidneycolic/orexpbladderstone/orexpureterstone/orexpurolithiasis/orexpnephrolithiasis/orexpureterobstruction/

2 ((Urin*orrenalorkidneyorureter*orbladder)adj3(stone*orcalcul*orcolic*orlith*orobstruct*orocclusi*)).mp.

3 ((Kidneyorureter*)adj2diseas*).mp. 4 (Urolith*ornephrolith*).mp.

5 or/1-4Population-Renalcolic

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6

expnonsteroidantiinflammatoryagent/orexpcyclooxygenase2inhibitor/orexpindometacin/orexppiroxicam/orexpacetylsalicylicacid/orexpcelecoxib/orexpdiclofenac/orexpibuprofen/orexpnaproxen/orexpazapropazone/orexpacetylsalicylicacid/orexpketoprofen/orexpsalicylicacid/orexpketorolac/orexpketoprofen/orexpsalicylicacidderivative/orexpetodolac/orexpfenoprofen/orexpsulindac/orexptolmetin/orexpmesalazine/orexpaminosalicylicacid/

7((Nonsteroidaladj2antiinflammatory)or(Non-steroidaladj2antiinflammatory)or(Nonsteroidaladj2anti-inflammatory)or(Non-steroidaladj2anti-inflammatory)).mp.

8 NSAID*.mp.




12 (Apazon*orAzapropazon*orcinnopropazon*).mp. 13 (Aspirin*oracetylsalordispriloreasprin*orsalicylic*).mp.

14(Ibuprofenorbrufenornuprinorrufenorsalprofenordolgitorsalprofenoradvil*ormotrinornurofenoractiprofenoraddaprinoraktrenoranadinorbugesicoribuprox).mp.




18 (etodolacorramodarorultradoloretovaordualganoretodinoretopanorflancoxorproxymoretodineordolarit).mp.


20 (Piroxicamorfeldeneordolocareordolonexorketolin).mp. 21 (Meloxicamormobicorvivlodex).mp. 22 (Tenoxicamormobiflex).mp. 23 (celecoxiborcelebrexorcelebra).mp. 24 (rofecoxiborvioxxorceoxxorceeoxx).mp. 25 (valdecoxiborbextra).mp.


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32


33 or/6-32 NSAIDS

34 expopiate/orexpnarcoticanalgesicagent/orexpopiateagonist/

35exphydrocodone/orexpdextropropoxyphene/orexpfentanyl/orexppethidine/orexpmethadone/orexpoxymorphone/orexppentazocine/orexptramadol/

36 opioid*.mp. 37 expalfentanil/oralfentanil*.mp. 38 expcodeine/orcodein*.mp. 39 (hydrocodon*orvicodin*ornorcoorlortaborzohydro).mp. 40 expoxycodone/oroxycodon*.mp.






46 expmorphine/orexpmorphinederivative/




50 (tramadolorultram).mp. 51 or/34-50 Opioids52 expparacetamol/

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53



56 5and33and54NSAIDSVsParacetamol


58 RETRACTEDARTICLE/ 59 or/57-58 RCTs60 (animal$nothuman$).sh,hw.

61 (bookorconferencepaperoreditorialorletterorreview).pt.notexprandomizedcontrolledtrial/

62(randomsampl$orrandomdigit$orrandomeffect$orrandomsurveyorrandomregression).ti,ab.notexprandomizedcontrolledtrial/

63 or/60-62non-humansubjectornonRCTs


6555and64

NSAIDSVsOpioids+HumansubjectRCTs

66

56and64

NSAIDSVsParacetamol+HumansubjectRCTs

6765or66

NSAIDS(Opioidsorparacetamol)inhumansubjectRCTs

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No



Title:




Authors:


author

1




1

Support:



Role of sponsor

or funder


INTRODUCTION




4

METHODS



4-5



6


repeated

6 and

Appendix-A

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Study records:

Data

management


Selection

process



7

Data collection

process



7



7

Outcomes and

prioritization


rationale

8

Risk of bias in

individual studies



8







Confidence in

cumulative evidence







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What is the best analgesic option for patients presenting with renal colic to the Emergency department? Protocol for

a systematic review and meta-analysis.

Journal: BMJ Open

Manuscript ID bmjopen-2016-015002.R2


Date Submitted by the Author: 06-Mar-2017

Complete List of Authors: Pathan, Sameer; Hamad Medical Corp, Emergency Department; Monash University School of Public Health and Preventive Medicine, Mitra, Biswadev; Monash University,

Romero, Lorena ; The Ian Potter Library, Ground Floor, AMREP Building, The Alfred Cameron, Peter; Monash University, Department of Epidemiology and Preventive Medicine

Primary Subject Heading:

Emergency medicine

Secondary Subject Heading: Evidence based practice, Medical management, Urology, Research methods





jopen.bmj.com

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MJ O


ay 2017. Dow

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1

What is the best analgesic option for patients presenting with renal colic to the

Emergency department? Protocol for a systematic review and meta-analysis.



MBBS, CABEM, MRCEM




BA, MBIT


MBBS, MD, FACEM

Affiliations






1. [email protected]








Telephone: 00974 6685 7650








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2

ABSTRACT

Introduction


There is variability in practice regarding the choice of initial analgesic to be used in renal

colic. The aim of this article is to outline the protocol for review of the efficacy and

safety of NSAIDS, opioids, and paracetamol use in renal colic pain management.





published until 1st









discussion and reaching consensus, if not, a third reviewer will arbitrate. Quantitative






publish the result of this review in a peer-reviewed journal.

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3

Strengths and limitations of this study

• Systematic review and meta-analysis of randomised controlled trials

• We plan to follow the Preferred Reporting Items for Systematic review and

Meta-Analysis Protocols (PRISMA-P), Grading of Recommendations Assessment,

Development and Evaluation (GRADE) framework and COCHRANE tools for

assessing the risk of bias.

• We anticipate difficulty in pooling data due to heterogeneity among the

published research.

• It will provide robust evidence in deciding superiority among commonly used

analgesics, and help to improve guidance for protocolised analgesia in renal

colic.

INTRODUCTION

Kidney stones are common in the “stone belt” region, which extends over America


Globally, the lifetime prevalence of stone disease is 10-15%, and accounts for millions of

patient visits to emergency departments (ED) or the outpatient clinics. 1

2 The acute


urinary tract produces this excruciating pain. The National Health Service (NHS),

England statistics for year 2012-13, estimated the cost for renal colic was nearly £20

million, where median patient stay in the hospital was 1 day. 3 In the management of

renal colic, one of the priorities in the ED is to provide quick, safe and effective

analgesia.




selection of first-line analgesia in the ED are efficacy, safety, the ease of rapid

administration and logistics involved. Effective ongoing analgesia can be practically

challenging to deliver in an ED with a diverse population, and a high volume of patients

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4

being managed concurrently.6 A previously published meta-analysis comparing NSAIDS

with opioids suggested NSAIDS were better than opioids in terms of requiring less

rescue analgesia and having fewer side effect. However, it did not establish superior

efficacy of either drug group.5 7

Although the European Association of Urology guidelines

on urolithiasis recommends NSAIDs as the first choice, the use of intravenous opioids as

the first-line analgesic in renal colic, continues to be a common practice in many

developed countries.8-12

However, the logistical delay involved in intravenous

administrations, dose-dependent side-effects, need for titrating dosage, and overly

bureaucratic restrictions are some of the challenges associated with the IV opioid use as

the first-line analgesic in the busy ED. 13 14

15

Routine use of NSAIDS has been limited

because of the fear of gastrointestinal (GI) and renal complications. In addition, there

has been undue emphasis placed on the possibility of abscess and muscle necrosis

secondary to intramuscular injection, given the extremely low level of documented

cases.











heterogeneity between the studies included, did not allow pooled analysis to test the

superiority of a drug based on efficacy. 4 5




Fourthly, 12 of the 20 included trials used

pethidine as their opioid arm, which is not a commonly used opioid in current practice. 5

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5

Lastly, studies available to include at the time of review lacked consistent reporting of

serious adverse events such as renal failure and GI bleeding limiting comparability.





METHODS AND DESIGN




severe pain severity. If a study reports data on both adult and pediatric populations, we



Type of studies




we will use a professional translator to translate the text in English.








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6









• Pain recurrence


IM injection site)

Information sources



studies:












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7






Cochrane reviews4 5



were excluded as these drugs have a risk of agranulocytocis, and are no longer used as

routine analgesics.

Search strategy










Selection process








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8








Data items




sample size.









To compare outcomes, identification of the definition used for the primary outcome,

measuring tool used, change in pain scores, need for rescue analgesia and at what time,

side effects and follow up (GI bleed or renal impairment), will be assessed. Notes

important but not classified in the above category will be entered as a free text.


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9







Missing data









ANALYSIS

Data synthesis






different measurement scales were used, a standardized mean difference will be used

to express the results. For the adverse effects we will calculate the risk difference (RD)

with 95% CI. Skewed data and non-quantitative data will be presented descriptively.

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10


effect models or random effect models will be used appropriately based on the






Subgroup analysis







Meta-bias(es)




2005, we








methodology.

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11

DISCUSSION












publish the result of this review in a peer-reviewed journal. We believe that the results

of this review will provide robust evidence in deciding superiority among commonly

used analgesics, and help to improve guidance for protocolised analgesia in renal colic.

Contributions: SAP is the guarantor. SAP, BM and PAC drafted the protocol for the




manuscript.



REFERENCES



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12













2015/08/06]












First: 2007/10/05]




1994/06/27]

8. Dave C, Shetty S, Faraj K. Nephrolithiasis Treatment & Management: WebMD;

2016 [updated Dec 03, 2016. Available from:

http://emedicine.medscape.com/article/437096-treatment - d7 accessed

Feb 05, 2017.

9. Ketabchi AA, Ebad-Zadeh MR, Parvaresh S, et al. Opium Dependency in Recurrent

Painful Renal Lithiasis Colic. Addiction & Health 2012;4(1-2):73-8.

10. Worster A. Renal colic. In: Thomas SH, ed. Emergency Department Analgesia: An

Evidence-Based Guide. New York: Cambridge University Press 2008:359-62.

11. Bounes V, Valle B, Concina F, et al. Treatment of Acute Renal Colic in US and

French EDs: Simulated Cases and Real Cases in Acute Pain Management. The

American journal of emergency medicine 2016;34(10):1955-58. doi:

10.1016/j.ajem.2016.06.107 [published Online First: 2016/07/20]

12. Turk C, Petrik A, Sarica K, et al. EAU Guidelines on Diagnosis and Conservative

Management of Urolithiasis. European urology 2016;69(3):468-74. doi:

10.1016/j.eururo.2015.07.040 [published Online First: 2015/09/01]

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13

13. Manjiani D, Paul DB, Kunnumpurath S, et al. Availability and Utilization of

Opioids for Pain Management: Global Issues. The Ochsner Journal

2014;14(2):208-15.



England) 2016;387(10028):1644-56. doi: 10.1016/s0140-6736(16)00161-6





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AppendixA

OvidMEDLINE(R)1946toPresentwithDailyUpdate+In-Process&OtherNon-IndexedCitations(2016Month,Date)


1

expUrinaryBladderCalculi/orexpUrinaryCalculi/orexpKidneyCalculi/orexpUreteralCalculi/orexpUrolithiasis/orexpNephrolithiasis/orexpRenalColic/orexpUreteralDiseases/orexpUreteralObstruction/orexpKidneyDiseases/

2((Urin*orrenalorkidneyorureter*orbladder)adj3(stone*orcalcul*orcolic*orlith*orobstruct*orocclusi*)).mp.

3 ((Kidneyorureter*)adj2diseas*).mp. 4 (Urolith*ornephrolith*).mp. 5 or/1-4 Population-Renalcolic

6expAnti-InflammatoryAgents,Non-Steroidal/orexpCyclooxygenaseInhibitors/orexpCyclooxygenase2Inhibitors/

7

((Nonsteroidaladj2antiinflammatory)or(Non-steroidaladj2antiinflammatory)or(Nonsteroidaladj2anti-inflammatory)or(Non-steroidaladj2anti-inflammatory)).mp.

8

expdiclofenac/orexpketorolac/orexpapazone/orexpaspirin/orexpibuprofen/orexpketoprofen/orexpSalicylates/orexpetodolac/orexpnaproxen/orexpindomethacin/orexppiroxicam/orexpcelecoxib/orexpfenoprofen/orexpsulindac/orexptolmetin/orexpmesalazine/orexpaminosalicylicacid/

9 NSAID*.mp.




13 (Apazon*orAzapropazon*orcinnopropazon*).mp.

14 (Aspirin*oracetylsal*ordispriloreasprin*orsalicylic*).mp.

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15

(Ibuprofenorbrufenornuprinorrufenorsalprofenordolgitorsalprofenoradvil*ormotrinornurofenoractiprofenoraddaprinoraktrenoranadinorbugesicoribuprox).mp.




19(etodolacorramodarorultradoloretovaordualganoretodinoretopanorflancoxorproxymoretodineordolarit).mp.


21 (Piroxicamorfeldeneordolocareordolonexorketolin).mp.

22 (Meloxicamormobicorvivlodex).mp. 23 (Tenoxicamormobiflex).mp. 24 (celecoxiborcelebrexorcelebra).mp. 25 (rofecoxiborvioxxorceoxxorceeoxx).mp. 26 (valdecoxiborbextra).mp.





33


34 or/6-33 NSAIDS

35 expAnalgesics,opioid/orexpalkaloids,opiate/orexpnarcotics/

36 opioid*.mp.

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37

exphydrocodone/orexpdextropropoxyphene/orexpfentanyl/orexpmeperidine/orexpmethadone/orexpMorphine/orexpMorphineDerivatives/orexpoxymorphone/orexppentazocine/orexptramadol/

38 expalfentanil/oralfentanil*.mp. 39 expcodeine/orcodein*.mp.

40 (hydrocodon*orvicodin*ornorcoorlortaborzohydro).mp.

41 expoxycodone/oroxycodon*.mp.









50 (tramadolorultram).mp. 51 or/35-50 Opioids52 expAcetaminophen/

53



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56 5and34and54 NSAIDSVsParacetamol57 randomizedcontrolledtrial.pt. 58 controlledclinicaltrial.pt.


60 (retractionofpublicationorretractedpublication).pt. 61 or/57-60 RCTs62 (animalsnothumans).sh.

63((commentoreditorialormeta-analysisorpractice-guidelineorrevieworletterorjournalcorrespondence)not"randomizedcontrolledtrial").pt.

64(randomsampl$orrandomdigit$orrandomeffect$orrandomsurveyorrandomregression).ti,ab.not"randomizedcontrolledtrial".pt.

65 or/62-64 non-humansubjectornonRCTs


67 55and66 NSAIDSVsOpioids+HumansubjectRCTs

68 56and66NSAIDSVsParacetamol+HumansubjectRCTs

69 67or68NSAIDS(Opioidsorparacetamol)inhumansubjectRCTs

EmbaseClassic+Embase1947to2016Month,Date


1expkidneypain/orexpkidneycolic/orexpbladderstone/orexpureterstone/orexpurolithiasis/orexpnephrolithiasis/orexpureterobstruction/

2 ((Urin*orrenalorkidneyorureter*orbladder)adj3(stone*orcalcul*orcolic*orlith*orobstruct*orocclusi*)).mp.

3 ((Kidneyorureter*)adj2diseas*).mp. 4 (Urolith*ornephrolith*).mp.

5 or/1-4Population-Renalcolic

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6

expnonsteroidantiinflammatoryagent/orexpcyclooxygenase2inhibitor/orexpindometacin/orexppiroxicam/orexpacetylsalicylicacid/orexpcelecoxib/orexpdiclofenac/orexpibuprofen/orexpnaproxen/orexpazapropazone/orexpacetylsalicylicacid/orexpketoprofen/orexpsalicylicacid/orexpketorolac/orexpketoprofen/orexpsalicylicacidderivative/orexpetodolac/orexpfenoprofen/orexpsulindac/orexptolmetin/orexpmesalazine/orexpaminosalicylicacid/

7((Nonsteroidaladj2antiinflammatory)or(Non-steroidaladj2antiinflammatory)or(Nonsteroidaladj2anti-inflammatory)or(Non-steroidaladj2anti-inflammatory)).mp.

8 NSAID*.mp.




12 (Apazon*orAzapropazon*orcinnopropazon*).mp. 13 (Aspirin*oracetylsalordispriloreasprin*orsalicylic*).mp.

14(Ibuprofenorbrufenornuprinorrufenorsalprofenordolgitorsalprofenoradvil*ormotrinornurofenoractiprofenoraddaprinoraktrenoranadinorbugesicoribuprox).mp.




18 (etodolacorramodarorultradoloretovaordualganoretodinoretopanorflancoxorproxymoretodineordolarit).mp.


20 (Piroxicamorfeldeneordolocareordolonexorketolin).mp. 21 (Meloxicamormobicorvivlodex).mp. 22 (Tenoxicamormobiflex).mp. 23 (celecoxiborcelebrexorcelebra).mp. 24 (rofecoxiborvioxxorceoxxorceeoxx).mp. 25 (valdecoxiborbextra).mp.


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32


33 or/6-32 NSAIDS

34 expopiate/orexpnarcoticanalgesicagent/orexpopiateagonist/

35exphydrocodone/orexpdextropropoxyphene/orexpfentanyl/orexppethidine/orexpmethadone/orexpoxymorphone/orexppentazocine/orexptramadol/

36 opioid*.mp. 37 expalfentanil/oralfentanil*.mp. 38 expcodeine/orcodein*.mp. 39 (hydrocodon*orvicodin*ornorcoorlortaborzohydro).mp. 40 expoxycodone/oroxycodon*.mp.






46 expmorphine/orexpmorphinederivative/




50 (tramadolorultram).mp. 51 or/34-50 Opioids52 expparacetamol/

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53



56 5and33and54NSAIDSVsParacetamol


58 RETRACTEDARTICLE/ 59 or/57-58 RCTs60 (animal$nothuman$).sh,hw.

61 (bookorconferencepaperoreditorialorletterorreview).pt.notexprandomizedcontrolledtrial/

62(randomsampl$orrandomdigit$orrandomeffect$orrandomsurveyorrandomregression).ti,ab.notexprandomizedcontrolledtrial/

63 or/60-62non-humansubjectornonRCTs


6555and64

NSAIDSVsOpioids+HumansubjectRCTs

66

56and64

NSAIDSVsParacetamol+HumansubjectRCTs

6765or66

NSAIDS(Opioidsorparacetamol)inhumansubjectRCTs

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No



Title:




Authors:


author

1




1

Support:



Role of sponsor

or funder


INTRODUCTION




4

METHODS



4-5



6


repeated

6 and

Appendix-A

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Study records:

Data

management


Selection

process



7

Data collection

process



7



7

Outcomes and

prioritization


rationale

8

Risk of bias in

individual studies



8







Confidence in

cumulative evidence







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What is the best analgesic option for patients …...of renal colic well before any imaging can be...

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Transcript of What is the best analgesic option for patients …...of renal colic well before any imaging can be...