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Perioperative intravenous S(+)-ketamine for acute postoperative pain in adults: study protocol for a multicentre, randomised, open-label, positive-controlled, pragmatic clinical trial (SAFE-SK-A trial)

INTRODUCTION: Postoperative pain remains incompletely controlled for decades. Recently, multimodal analgesia is emerging as a potential approach in the management of postoperative pain. Therein, S(+)-ketamine is appealing as an adjuvant drug in multimodal analgesia due to its unique pharmacological...

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Autores principales: Wang, Hong, Duan, Chong-Yang, Huang, Wen-Qi, Zhao, Ping, Zhou, Li-Zhi, Liu, Yan-Hong, Liu, Cun-Ming, Chu, Hai-Chen, Wang, Qiang, Diao, Yu-Gang, Hua, Zhen, Meng, Qing-Tao, Li, Hao, Zhang, Xiao-Ying, Mi, Wei-Dong, Chen, Ping-Yan
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8679135/
https://www.ncbi.nlm.nih.gov/pubmed/34916327
http://dx.doi.org/10.1136/bmjopen-2021-054681
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author Wang, Hong
Duan, Chong-Yang
Huang, Wen-Qi
Zhao, Ping
Zhou, Li-Zhi
Liu, Yan-Hong
Liu, Cun-Ming
Chu, Hai-Chen
Wang, Qiang
Diao, Yu-Gang
Hua, Zhen
Meng, Qing-Tao
Li, Hao
Zhang, Xiao-Ying
Mi, Wei-Dong
Chen, Ping-Yan
author_facet Wang, Hong
Duan, Chong-Yang
Huang, Wen-Qi
Zhao, Ping
Zhou, Li-Zhi
Liu, Yan-Hong
Liu, Cun-Ming
Chu, Hai-Chen
Wang, Qiang
Diao, Yu-Gang
Hua, Zhen
Meng, Qing-Tao
Li, Hao
Zhang, Xiao-Ying
Mi, Wei-Dong
Chen, Ping-Yan
author_sort Wang, Hong
collection PubMed
description INTRODUCTION: Postoperative pain remains incompletely controlled for decades. Recently, multimodal analgesia is emerging as a potential approach in the management of postoperative pain. Therein, S(+)-ketamine is appealing as an adjuvant drug in multimodal analgesia due to its unique pharmacological advantages. This pragmatic clinical trial (SAFE-SK-A trial) is designed to investigate the analgesic effect and safety of S(+)-ketamine for acute postoperative pain in adults and explore the optimal strategy of perioperative intravenous S(+)-ketamine in a real-world setting. METHODS AND ANALYSIS: This multicentre, randomised, open-label, positive-controlled, pragmatic clinical trial (SAFE-SK-A study) is planned to conduct in 80 centres from China and recruit a total of 12 000 adult participants undergoing a surgical procedure under general anaesthesia. Patient recruitment started in June 2021 and will end in June 2022. Participants will be randomised in a ratio of 2:1 to either receive perioperative intravenous S(+)-ketamine plus conventional anaesthesia or conventional anaesthesia only. Given the pragmatic nature of the study, no specific restriction as to the administration dosage, route, time, synergistic regimen or basic analgesics. Primary endpoints are the area under the broken line of Numerical Rating Scale (NRS) scores for pain intensity and the total opioid consumption within 48 hours postoperative. Secondary endpoints are postoperative NRS scores, the anaesthesia recovery time, time of first rescue analgesia, the incidence of rescue analgesia, the incidence of postoperative delirium, patient questionnaire for effect, changes from baseline in cognitive function and anxiety and depression, as well as the adverse events and pharmacoeconomic outcomes. The general linear model will be used for the primary endpoint, and appropriate methods will be used for the secondary endpoints. ETHICS AND DISSEMINATION: This trial has been approved by the local Institutional Review Board (S2021-026-02) and conducted following the Declaration of Helsinki. Results of this trial will be publicly disclosed and published in scientific journals. TRIAL REGISTRATION NUMBER: NCT04837170; Pre-results.
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spelling pubmed-86791352022-01-04 Perioperative intravenous S(+)-ketamine for acute postoperative pain in adults: study protocol for a multicentre, randomised, open-label, positive-controlled, pragmatic clinical trial (SAFE-SK-A trial) Wang, Hong Duan, Chong-Yang Huang, Wen-Qi Zhao, Ping Zhou, Li-Zhi Liu, Yan-Hong Liu, Cun-Ming Chu, Hai-Chen Wang, Qiang Diao, Yu-Gang Hua, Zhen Meng, Qing-Tao Li, Hao Zhang, Xiao-Ying Mi, Wei-Dong Chen, Ping-Yan BMJ Open Anaesthesia INTRODUCTION: Postoperative pain remains incompletely controlled for decades. Recently, multimodal analgesia is emerging as a potential approach in the management of postoperative pain. Therein, S(+)-ketamine is appealing as an adjuvant drug in multimodal analgesia due to its unique pharmacological advantages. This pragmatic clinical trial (SAFE-SK-A trial) is designed to investigate the analgesic effect and safety of S(+)-ketamine for acute postoperative pain in adults and explore the optimal strategy of perioperative intravenous S(+)-ketamine in a real-world setting. METHODS AND ANALYSIS: This multicentre, randomised, open-label, positive-controlled, pragmatic clinical trial (SAFE-SK-A study) is planned to conduct in 80 centres from China and recruit a total of 12 000 adult participants undergoing a surgical procedure under general anaesthesia. Patient recruitment started in June 2021 and will end in June 2022. Participants will be randomised in a ratio of 2:1 to either receive perioperative intravenous S(+)-ketamine plus conventional anaesthesia or conventional anaesthesia only. Given the pragmatic nature of the study, no specific restriction as to the administration dosage, route, time, synergistic regimen or basic analgesics. Primary endpoints are the area under the broken line of Numerical Rating Scale (NRS) scores for pain intensity and the total opioid consumption within 48 hours postoperative. Secondary endpoints are postoperative NRS scores, the anaesthesia recovery time, time of first rescue analgesia, the incidence of rescue analgesia, the incidence of postoperative delirium, patient questionnaire for effect, changes from baseline in cognitive function and anxiety and depression, as well as the adverse events and pharmacoeconomic outcomes. The general linear model will be used for the primary endpoint, and appropriate methods will be used for the secondary endpoints. ETHICS AND DISSEMINATION: This trial has been approved by the local Institutional Review Board (S2021-026-02) and conducted following the Declaration of Helsinki. Results of this trial will be publicly disclosed and published in scientific journals. TRIAL REGISTRATION NUMBER: NCT04837170; Pre-results. BMJ Publishing Group 2021-12-16 /pmc/articles/PMC8679135/ /pubmed/34916327 http://dx.doi.org/10.1136/bmjopen-2021-054681 Text en © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. https://creativecommons.org/licenses/by-nc/4.0/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, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) .
spellingShingle Anaesthesia
Wang, Hong
Duan, Chong-Yang
Huang, Wen-Qi
Zhao, Ping
Zhou, Li-Zhi
Liu, Yan-Hong
Liu, Cun-Ming
Chu, Hai-Chen
Wang, Qiang
Diao, Yu-Gang
Hua, Zhen
Meng, Qing-Tao
Li, Hao
Zhang, Xiao-Ying
Mi, Wei-Dong
Chen, Ping-Yan
Perioperative intravenous S(+)-ketamine for acute postoperative pain in adults: study protocol for a multicentre, randomised, open-label, positive-controlled, pragmatic clinical trial (SAFE-SK-A trial)
title Perioperative intravenous S(+)-ketamine for acute postoperative pain in adults: study protocol for a multicentre, randomised, open-label, positive-controlled, pragmatic clinical trial (SAFE-SK-A trial)
title_full Perioperative intravenous S(+)-ketamine for acute postoperative pain in adults: study protocol for a multicentre, randomised, open-label, positive-controlled, pragmatic clinical trial (SAFE-SK-A trial)
title_fullStr Perioperative intravenous S(+)-ketamine for acute postoperative pain in adults: study protocol for a multicentre, randomised, open-label, positive-controlled, pragmatic clinical trial (SAFE-SK-A trial)
title_full_unstemmed Perioperative intravenous S(+)-ketamine for acute postoperative pain in adults: study protocol for a multicentre, randomised, open-label, positive-controlled, pragmatic clinical trial (SAFE-SK-A trial)
title_short Perioperative intravenous S(+)-ketamine for acute postoperative pain in adults: study protocol for a multicentre, randomised, open-label, positive-controlled, pragmatic clinical trial (SAFE-SK-A trial)
title_sort perioperative intravenous s(+)-ketamine for acute postoperative pain in adults: study protocol for a multicentre, randomised, open-label, positive-controlled, pragmatic clinical trial (safe-sk-a trial)
topic Anaesthesia
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8679135/
https://www.ncbi.nlm.nih.gov/pubmed/34916327
http://dx.doi.org/10.1136/bmjopen-2021-054681
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