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Satisfactory Analgesia with Minimal Emesis in Day Surgeries (SAME DayS): a protocol for a randomised controlled trial of morphine versus hydromorphone

INTRODUCTION: There has been an exponential increase in the number of ambulatory surgeries (AS). Pain and postoperative nausea vomiting (PONV) affects the recovery, discharge and overall satisfaction of patients having AS. Opioids remain the primary modality for moderate to severe pain. Since there...

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Autores principales: Shanthanna, Harsha, Paul, James, Lovrics, Peter, Devereaux, P J, Bhandari, Mohit, Thabane, Lehana
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6020940/
https://www.ncbi.nlm.nih.gov/pubmed/29934395
http://dx.doi.org/10.1136/bmjopen-2018-022504
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author Shanthanna, Harsha
Paul, James
Lovrics, Peter
Devereaux, P J
Bhandari, Mohit
Thabane, Lehana
author_facet Shanthanna, Harsha
Paul, James
Lovrics, Peter
Devereaux, P J
Bhandari, Mohit
Thabane, Lehana
author_sort Shanthanna, Harsha
collection PubMed
description INTRODUCTION: There has been an exponential increase in the number of ambulatory surgeries (AS). Pain and postoperative nausea vomiting (PONV) affects the recovery, discharge and overall satisfaction of patients having AS. Opioids remain the primary modality for moderate to severe pain. Since there is no perfect opioid, physicians should ideally use the opioid that optimally balances benefits and risks. Present decisions on the choice between morphine (M) and hydromorphone (HM) are based on individual experience and observation. Our primary objective is to compare the proportion of patients having AS achieving satisfactory analgesia without significant PONV when using M compared with HM. Secondarily we will compare the proportion of patients with adverse events, analgesic used, patient satisfaction, time to discharge and postdischarge symptoms. METHODS AND ANALYSIS: This is a two-arm, multicentre, parallel group, randomised controlled trial of 400 patients having AS. Eligible patients undergoing AS of the abdominal and pelvic regions with a potential to cause moderate to severe pain will be recruited in the preoperative clinic. Using a computer-generated randomization, with a 1:1 allocation ratio, patients will be randomised to M or HM. Patients, healthcare providers and research personnel will be blinded. Study interventions will be administered in the recovery using equianalgesic doses of M or HM in concealed syringes. Patients will be followed in hospital and up to 3 months. Intention-to-treat approach will be used for analysis. ETHICS AND DISSEMINATION: This study has been approved by the Hamilton integrated research ethics board. We plan to publish our trial findings and present our findings at scientific meetings. TRAIL REGISTRATION NUMBER: NCT02223377; Pre-results.
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spelling pubmed-60209402018-06-29 Satisfactory Analgesia with Minimal Emesis in Day Surgeries (SAME DayS): a protocol for a randomised controlled trial of morphine versus hydromorphone Shanthanna, Harsha Paul, James Lovrics, Peter Devereaux, P J Bhandari, Mohit Thabane, Lehana BMJ Open Anaesthesia INTRODUCTION: There has been an exponential increase in the number of ambulatory surgeries (AS). Pain and postoperative nausea vomiting (PONV) affects the recovery, discharge and overall satisfaction of patients having AS. Opioids remain the primary modality for moderate to severe pain. Since there is no perfect opioid, physicians should ideally use the opioid that optimally balances benefits and risks. Present decisions on the choice between morphine (M) and hydromorphone (HM) are based on individual experience and observation. Our primary objective is to compare the proportion of patients having AS achieving satisfactory analgesia without significant PONV when using M compared with HM. Secondarily we will compare the proportion of patients with adverse events, analgesic used, patient satisfaction, time to discharge and postdischarge symptoms. METHODS AND ANALYSIS: This is a two-arm, multicentre, parallel group, randomised controlled trial of 400 patients having AS. Eligible patients undergoing AS of the abdominal and pelvic regions with a potential to cause moderate to severe pain will be recruited in the preoperative clinic. Using a computer-generated randomization, with a 1:1 allocation ratio, patients will be randomised to M or HM. Patients, healthcare providers and research personnel will be blinded. Study interventions will be administered in the recovery using equianalgesic doses of M or HM in concealed syringes. Patients will be followed in hospital and up to 3 months. Intention-to-treat approach will be used for analysis. ETHICS AND DISSEMINATION: This study has been approved by the Hamilton integrated research ethics board. We plan to publish our trial findings and present our findings at scientific meetings. TRAIL REGISTRATION NUMBER: NCT02223377; Pre-results. BMJ Publishing Group 2018-06-22 /pmc/articles/PMC6020940/ /pubmed/29934395 http://dx.doi.org/10.1136/bmjopen-2018-022504 Text en © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
spellingShingle Anaesthesia
Shanthanna, Harsha
Paul, James
Lovrics, Peter
Devereaux, P J
Bhandari, Mohit
Thabane, Lehana
Satisfactory Analgesia with Minimal Emesis in Day Surgeries (SAME DayS): a protocol for a randomised controlled trial of morphine versus hydromorphone
title Satisfactory Analgesia with Minimal Emesis in Day Surgeries (SAME DayS): a protocol for a randomised controlled trial of morphine versus hydromorphone
title_full Satisfactory Analgesia with Minimal Emesis in Day Surgeries (SAME DayS): a protocol for a randomised controlled trial of morphine versus hydromorphone
title_fullStr Satisfactory Analgesia with Minimal Emesis in Day Surgeries (SAME DayS): a protocol for a randomised controlled trial of morphine versus hydromorphone
title_full_unstemmed Satisfactory Analgesia with Minimal Emesis in Day Surgeries (SAME DayS): a protocol for a randomised controlled trial of morphine versus hydromorphone
title_short Satisfactory Analgesia with Minimal Emesis in Day Surgeries (SAME DayS): a protocol for a randomised controlled trial of morphine versus hydromorphone
title_sort satisfactory analgesia with minimal emesis in day surgeries (same days): a protocol for a randomised controlled trial of morphine versus hydromorphone
topic Anaesthesia
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6020940/
https://www.ncbi.nlm.nih.gov/pubmed/29934395
http://dx.doi.org/10.1136/bmjopen-2018-022504
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