Evidence Review E: Pain Management
Total Page：16
File Type：pdf, Size：1020Kb
National Institute for Health and Care Excellence Final Renal and ureteric stones: assessment and management Pain management NICE guideline NG118 Intervention evidence review (E) January 2019 Final This evidence review was developed by the National Guideline Centre FINAL Contents Disclaimer The recommendations in this guideline represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals are expected to take this guideline fully into account, alongside the individual needs, preferences and values of their patients or service users. The recommendations in this guideline are not mandatory and the guideline does not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and, where appropriate, their carer or guardian. Local commissioners and providers have a responsibility to enable the guideline to be applied when individual health professionals and their patients or service users wish to use it. They should do so in the context of local and national priorities for funding and developing services, and in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities. Nothing in this guideline should be interpreted in a way that would be inconsistent with compliance with those duties. NICE guidelines cover health and care in England. Decisions on how they apply in other UK countries are made by ministers in the Welsh Government, Scottish Government, and Northern Ireland Executive. All NICE guidance is subject to regular review and may be updated or withdrawn. Copyright © NICE 2019. All rights reserved. Subject to Notice of rights. ISBN: 978-1-4731-3190-3 FINAL Contents Contents 1 Pain management ......................................................................................................... 5 1.1 Review question: What is the clinical and cost-effectiveness of drugs in managing acute pain in people with symptomatic renal or ureteric stones? ........... 5 1.2 Introduction ........................................................................................................... 5 1.3 PICO table ............................................................................................................. 5 1.4 Clinical evidence ................................................................................................... 6 1.4.1 Included studies ......................................................................................... 6 1.4.2 Excluded studies ........................................................................................ 6 1.4.3 Heterogeneity ............................................................................................ 6 1.4.4 Summary of clinical studies included in the evidence review ...................... 7 1.4.5 Quality assessment of clinical studies included in the evidence review .... 22 1.5 Economic evidence ............................................................................................. 45 1.5.1 Included studies ....................................................................................... 45 1.5.2 Excluded studies ...................................................................................... 45 1.5.3 Unit costs ................................................................................................. 45 1.6 Resource costs ................................................................................................... 46 1.7 Evidence statements ........................................................................................... 46 1.7.1 Clinical evidence statements .................................................................... 46 1.7.2 Health economic evidence statements ..................................................... 49 1.8 The committee’s discussion of the evidence ........................................................ 49 1.8.1 Interpreting the evidence .......................................................................... 49 1.8.2 Cost effectiveness and resource use ....................................................... 53 1.8.3 Other factors the committee took into account ......................................... 55 References ......................................................................................................................... 57 Appendices ........................................................................................................................ 68 Appendix A: Review protocols ................................................................................... 68 Appendix B: Literature search strategies ................................................................... 71 Appendix C: Clinical evidence selection ..................................................................... 85 Appendix D: Clinical evidence tables ......................................................................... 86 Appendix E: Forest plots .......................................................................................... 177 Appendix F: GRADE tables ..................................................................................... 200 Appendix G: Health economic evidence selection .................................................... 222 Appendix H: Health economic evidence tables ........................................................ 223 Appendix I: Excluded studies.................................................................................. 223 Appendix J: Research recommendations ................................................................ 225 4 FINAL Pain management 1 Pain management 1.1 Review question: What is the clinical and cost- effectiveness of drugs in managing acute pain in people with symptomatic renal or ureteric stones? 1.2 Introduction Pain relief is the first step in managing people with acute renal colic. Whilst NSAIDs are generally accepted as the first line treatment by health professionals, there is uncertainty in the efficacy of other treatment options such as antispasmodics, and there are concerns surrounding the use of opioids, because of their significant side effects, and because of the potential risks of misuse of a controlled drug. There are variations in practice with the method of administering pain relief, which has significant resource implications, particularly the use of intravenous or intramuscular methods requiring hospital attendance as well as variation in practice due to the patient’s age. An intramuscular route is rarely used in children due to the distress this may cause, and an intravenous route is often preferred in young children who won't swallow medication on demand. There is currently a lack of guidance on an evidence-based step-by-step approach to pain relief for patients presenting with renal/ureteric colic. 1.3 PICO table For full details see the review protocol in appendix A. Table 1: PICO characteristics of review question Population People (adults, children and young people) with symptomatic renal or ureteric stones Interventions NSAIDs Opioids/Opiates Paracetamol Antispasmodic/smooth muscle relaxant Comparisons Compared to: Each other (class comparison only; no within class comparison) No treatment Placebo Outcomes Critical outcomes: Quality of life Pain intensity (visual analogue scale, verbal ratings, descriptive scales, time to pain relief, need to rescue medication) Adverse events o Major: GI haemorrhage, acute kidney injury, respiratory depression, mortality, and cardiac event. o Minor: GI disturbance without bleeding (vomiting and nausea, constipation, diarrhoea, pain, dizziness, sleepiness, urinary retention) Important outcomes: Length of stay Use of healthcare services © NICE 2019. All rights reserved. Subject to Notice of rights. 5 FINAL Pain management Study design RCTs and systematic reviews of RCTs If no RCT evidence is available, search for non-randomised studies for children 1.4 Clinical evidence 1.4.1 Included studies Thirty-eight studies were included in the review;3, 4, 6, 9, 11, 15, 22, 27, 28, 32, 43, 49, 53, 54, 56, 62, 70, 71, 74, 77, 80, 82, 90, 93, 99, 100, 103, 114, 116, 120, 122, 123, 126, 129, 130, 133, 136, 144 these are summarised in Table 2 below. Twenty-two studies compared NSAIDS to opioids 4, 6, 9, 25, 27, 28, 49, 53, 54, 56, 70, 71, 80, 90, 100, 103, 114, 116, 120, 123, 133, 144, 3 studies compared NSAIDs to antispasmodics3, 32, 126,5 studies compared NSAIDs to paracetamol 6, 22, 62, 93, 103, 6 studies compared opioids to paracetamol 6, 11, 15, 82, 103, 122, 4 studies compared NSAIDs to placebo 3, 74, 77, 136, 2 studies compared opioid to antispasmodics 99, 130, 1 study compared opioid to placebo 15, 1 study compared paracetamol to placebo 15, 1 study compared antispasmodics to placebo 3 and 4 studies compared combinations of pain relief medications. 54, 93, 126, 129 Evidence from these studies is summarised in the clinical evidence summaries below in Table 3 to Table 11. See also the study selection flow chart in appendix C, study evidence tables in appendix D, forest plots in appendix E and GRADE tables in appendix H. Two Cochrane systematic reviews were identified, however both were excluded. Both were excluded due to deviation from the review protocol to include drugs that are excluded in this review. 1.4.2 Excluded studies See the excluded studies list in appendix I. 1.4.3 Heterogeneity