Makerere University College of Health Sciences School of Medicine Department of Anaesthesia and Critical Care

MAKERERE UNIVERSITY COLLEGE OF HEALTH SCIENCES SCHOOL OF MEDICINE DEPARTMENT OF ANAESTHESIA AND CRITICAL CARE KETAMINE-MIDAZOLAM VERSUS MORPHINE-MIDAZOLAM FOR CONTINOUS PATIENT SEDATION IN INTENSIVE CARE UNITS IN UGANDA. A RANDOMISED CONTROLLED TRIAL. (#NCT03407404) NAMATA CHRISTINE MBChB (Mak) A DISSERTATION SUBMITTED IN PARTIAL FULFILMENT OF THE REQUIREMENTS FOR THE AWARD OF THE DEGREE OF MASTER OF MEDICINE-ANAESTHESIOLOGY AND CRITICAL CARE- MAKERERE UNIVERSITY. TABLE OF CONTENTS DECLARATION ............................................................................................................................. i TABLE OF CONTENTS.................................................................................................................. ii DEDICATION ............................................................................................................................... v ACKNOWLEDGEMENTS. ............................................................................................................ vi LIST OF TABLES ........................................................................................................................ viii LIST OF FIGURES ........................................................................................................................ ix ACRONYMS AND ABBREVIATIONS ............................................................................................. x DEFINITIONS .............................................................................................................................. xi ABSTRACT ................................................................................................................................. xii CHAPTER ONE: INTRODUCTION ................................................................................................. 1 BACKGROUND ........................................................................................................................ 1 PROBLEM STATEMENT ........................................................................................................... 1 JUSTIFICATION ........................................................................................................................ 2 GENERAL OBJECTIVE .............................................................................................................. 2 SPECIFIC OBJECTIVES .............................................................................................................. 2 RESEARCH QUESTION ............................................................................................................. 3 CHAPTER TWO: LITERATURE REVIEW ........................................................................................ 4 Critical care illness and sedation ............................................................................................ 4 Sedation options, recommendations and usual care ............................................................ 4 About Ketamine ..................................................................................................................... 5 Ketamine use for continuous sedation in the ICU ................................................................. 6 Effects on vasopressor requirements, ICP, LOS ..................................................................... 7 CHAPTER THREE: RESEARCH METHODS .................................................................................... 8 Study design ........................................................................................................................... 8 Study setting and sites ........................................................................................................... 8 ii Target population ................................................................................................................... 8 Study population .................................................................................................................... 8 Selection criteria..................................................................................................................... 8 Randomization ....................................................................................................................... 9 Blinding ................................................................................................................................... 9 Allocation concealment .......................................................................................................... 9 Drug Preparation and Use. ..................................................................................................... 9 Participant follow up. ........................................................................................................... 10 Study Outcomes ................................................................................................................... 10 Primary outcomes ................................................................................................................ 10 Secondary outcomes ............................................................................................................ 10 Sample size ........................................................................................................................... 10 Distribution in the study sites .............................................................................................. 12 DATA MANAGEMENT ............................................................................................................... 12 Data collection...................................................................................................................... 12 Quality control ...................................................................................................................... 12 Data analysis ......................................................................................................................... 13 Data Safety and Monitoring Board. ..................................................................................... 13 Adverse event monitoring .................................................................................................... 13 Data dissemination ............................................................................................................... 14 ETHICAL CONSIDERATIONS ...................................................................................................... 15 LIMITATIONS ............................................................................................................................ 15 CHAPTER FOUR: STUDY RESULTS ............................................................................................. 17 Baseline characteristics. ....................................................................................................... 17 CHAPTER FIVE: DISCUSSION ..................................................................................................... 23 CONCLUSION ........................................................................................................................ 26 iii RECOMMENDATION ............................................................................................................. 26 REFERENCES ............................................................................................................................. 27 APPENDICES ............................................................................................................................. 30 APPENDIX I: STUDY COLLECTION TOOL................................................................................ 30 APPENDIX II: RICHMOND AGITATION-SEDATION SCORE ..................................................... 34 APPENDIX III: CONFUSION ASSESSMENT METHOD-INTENSIVE CARE UNIT (CAM-ICU) ...... 35 APPENDIX IV: THE MODIFIED EARLY WARNING SIGN SCORE .............................................. 36 APPENDIX IX: TIME FRAME .................................................................................................. 37 APPENDIX V: LETTER OF CONSENT....................................................................................... 38 TITLE: KETAMINE-MIDAZOLAM VERSUS MORPHINE-MIDAZOLAM FOR CONTINOUS PATIENT SEDATION IN INTENSIVE CARE UNITS IN UGANDA. A RANDOMISED CONTROLLED TRIAL. ......................................................................................................... 38 APPENDIX VI: ASSENT FORM 12 TO 14YRS ....................................................................... 40 APPENDIX VII: ASSENT FORM: 15 TO 17YRS ..................................................................... 43 APPENDIX VIII: TRANSLATED CONSENT FORMS ............................................................... 46 EKIWANDIIKO KYABAANA ABALI WAKATI WEMYAKA 15-17 EKYOKUKKIRIZA OKWETABA MU KUNOONYEREZA ........................................................................................................ 49 EKIWANDIIKO KYABAANA ABALI WAKATI WEMYAKA 12-14 EKYOKUKKIRIZA OKWETABA MU KUNOONYEREZA ........................................................................................................ 52 APPENDIX V: RUNYANKOLE CONSENT FORMS. ................................................................... 54 APPENDIX VI: ASSENT FORM 12 TO 14YRS ....................................................................... 57 ASSENT FORM: 15 TO 17YRS ...........................................................................................

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