National Institute for Health and Care Excellence Draft for Consultation Specialist neonatal respiratory care for babies born preterm [E] Evidence reviews for sedation and analgesia NICE guideline <TBC at publication> Evidence reviews October 2018 Draft for Consultation These evidence reviews were developed by the National Guideline Alliance, hosted by the Royal College of Obstetricians and Gynaecologists DRAFT FOR CONSULTATION Error! No text of specified style in document. 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/or their carer or guardian. Local commissioners and/or 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 All NICE guidance is subject to regular review and may be updated or withdrawn.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 2018. All rights reserved. Subject to Notice of rights. ISBN: DRAFT FOR CONSULTATION Contents Contents Sedation and analgesia....................................................................................................... 7 Review question 5.1 What is the effectiveness of morphine during respiratory support? ................................................................................................................ 8 Introduction ........................................................................................................... 8 Summary of the protocol ....................................................................................... 8 Clinical evidence ................................................................................................... 9 Summary of clinical studies included in the evidence review ................................. 9 Quality assessment of clinical studies included in the evidence review ............... 12 Economic evidence ............................................................................................. 12 Economic model .................................................................................................. 12 Clinical evidence statements ............................................................................... 12 Economic evidence statements ........................................................................... 18 Recommendations .............................................................................................. 18 Rationale and impact ........................................................................................... 19 The committee’s discussion of the evidence ........................................................ 19 References .......................................................................................................... 21 Review question 5.2 What is the effectiveness of using premedication for intubation in preterm babies? ............................................................................................... 23 Introduction ......................................................................................................... 23 Summary of the protocol ..................................................................................... 23 Clinical evidence ................................................................................................. 24 Summary of clinical studies included in the evidence review ............................... 25 Quality assessment of clinical studies included in the evidence review ............... 27 Economic evidence ............................................................................................. 27 Economic model .................................................................................................. 27 Clinical evidence statements ............................................................................... 28 Economic evidence statements ........................................................................... 36 Recommendations .............................................................................................. 36 Rationale and impact ........................................................................................... 37 The committee’s discussion of the evidence ........................................................ 37 References .......................................................................................................... 39 Appendices ........................................................................................................................ 41 Appendix A – Review protocols .................................................................................... 41 Review protocol for question 5.1 What is the effectiveness of morphine during respiratory support? ................................................................................. 41 Review protocol for question 5.2 What is the effectiveness of using premedication for intubation in preterm babies? ....................................... 47 Appendix B – Literature search strategies .................................................................... 54 4 DRAFT FOR CONSULTATION Contents Literature search strategies for question 5.1 What is the effectiveness of morphine during respiratory support? ....................................................... 54 Literature search strategies for question 5.2 What is the effectiveness of using premedication for intubation in preterm babies? ....................................... 61 Appendix C – Clinical evidence study selection ............................................................ 69 Clinical evidence study selection for question 5.1 What is the effectiveness of morphine during respiratory support? ....................................................... 69 Clinical evidence study selection for question 5.2 What is the effectiveness of using premedication for intubation in preterm babies? ............................. 70 Appendix D – Clinical evidence tables .......................................................................... 71 Clinical evidence tables for question 5.1 What is the effectiveness of morphine during respiratory support? ...................................................................... 71 Clinical evidence tables for question 5.2 What is the effectiveness of using premedication for intubation in preterm babies? ....................................... 90 Appendix E – Forest plots........................................................................................... 106 Forest plots for question 5.1 What is the effectiveness of morphine during respiratory support? ............................................................................... 106 Forest plots for question 5.2 What is the effectiveness of using premedication for intubation in preterm babies? ............................................................ 107 Appendix F – GRADE tables ...................................................................................... 108 GRADE tables for question 5.1 What is the effectiveness of morphine during respiratory support? ............................................................................... 108 GRADE tables for question 5.2 What is the effectiveness of using premedication for intubation in preterm babies? ..................................... 116 Appendix G – Economic evidence study selection ...................................................... 130 Economic evidence study selection for question 5.1 What is the effectiveness of morphine during respiratory support? ................................................. 130 Economic evidence study selection for question 5.2 What is the effectiveness of using premedication for intubation in preterm babies? ....................... 131 Appendix H – Economic evidence tables .................................................................... 132 Economic evidence table for question 5.1 What is the effectiveness of morphine during respiratory support? ..................................................... 132 Economic evidence table for question 5.2 What is the effectiveness of using premedication for intubation in preterm babies? ..................................... 132 Appendix I – Economic evidence profiles ................................................................... 133 Economic evidence profile for question 5.1 What is the effectiveness of morphine during respiratory support? ..................................................... 133 Economic