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Ketamine for acute pain after trauma: the KAPT randomized controlled trial
BACKGROUND: Evidence for effective pain management and opioid minimization of intravenous ketamine in elective surgery has been extrapolated to acutely injured patients, despite limited supporting evidence in this population. This trial seeks to determine the effectiveness of the addition of sub-dis...
Autores principales: | , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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BioMed Central
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9326146/ https://www.ncbi.nlm.nih.gov/pubmed/35897081 http://dx.doi.org/10.1186/s13063-022-06511-6 |
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author | Puzio, Thaddeus J. Klugh, James Wandling, Michael W. Green, Charles Balogh, Julius Prater, Samuel J. Stephens, Christopher T. Sergot, Paulina B. Wade, Charles E. Kao, Lillian S. Harvin, John A. |
author_facet | Puzio, Thaddeus J. Klugh, James Wandling, Michael W. Green, Charles Balogh, Julius Prater, Samuel J. Stephens, Christopher T. Sergot, Paulina B. Wade, Charles E. Kao, Lillian S. Harvin, John A. |
author_sort | Puzio, Thaddeus J. |
collection | PubMed |
description | BACKGROUND: Evidence for effective pain management and opioid minimization of intravenous ketamine in elective surgery has been extrapolated to acutely injured patients, despite limited supporting evidence in this population. This trial seeks to determine the effectiveness of the addition of sub-dissociative ketamine to a pill-based, opioid-minimizing multi-modal pain regimen (MMPR) for post traumatic pain. METHODS: This is a single-center, parallel-group, randomized, controlled comparative effectiveness trial comparing a MMPR to a MMPR plus a sub-dissociative ketamine infusion. All trauma patients 16 years and older admitted following a trauma which require intermediate (IMU) or intensive care unit (ICU) level of care are eligible. Prisoners, patients who are pregnant, patients not expected to survive, and those with contraindications to ketamine are excluded from this study. The primary outcome is opioid use, measured by morphine milligram equivalents (MME) per patient per day (MME/patient/day). The secondary outcomes include total MME, pain scores, morbidity, lengths of stay, opioid prescriptions at discharge, and patient centered outcomes at discharge and 6 months. DISCUSSION: This trial will determine the effectiveness of sub-dissociative ketamine infusion as part of a MMPR in reducing in-hospital opioid exposure in adult trauma patients. Furthermore, it will inform decisions regarding acute pain strategies on patient centered outcomes. TRIAL REGISTRATION: The Ketamine for Acute Pain Management After Trauma (KAPT) with registration # NCT04129086 was registered on October 16, 2019. |
format | Online Article Text |
id | pubmed-9326146 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-93261462022-07-27 Ketamine for acute pain after trauma: the KAPT randomized controlled trial Puzio, Thaddeus J. Klugh, James Wandling, Michael W. Green, Charles Balogh, Julius Prater, Samuel J. Stephens, Christopher T. Sergot, Paulina B. Wade, Charles E. Kao, Lillian S. Harvin, John A. Trials Study Protocol BACKGROUND: Evidence for effective pain management and opioid minimization of intravenous ketamine in elective surgery has been extrapolated to acutely injured patients, despite limited supporting evidence in this population. This trial seeks to determine the effectiveness of the addition of sub-dissociative ketamine to a pill-based, opioid-minimizing multi-modal pain regimen (MMPR) for post traumatic pain. METHODS: This is a single-center, parallel-group, randomized, controlled comparative effectiveness trial comparing a MMPR to a MMPR plus a sub-dissociative ketamine infusion. All trauma patients 16 years and older admitted following a trauma which require intermediate (IMU) or intensive care unit (ICU) level of care are eligible. Prisoners, patients who are pregnant, patients not expected to survive, and those with contraindications to ketamine are excluded from this study. The primary outcome is opioid use, measured by morphine milligram equivalents (MME) per patient per day (MME/patient/day). The secondary outcomes include total MME, pain scores, morbidity, lengths of stay, opioid prescriptions at discharge, and patient centered outcomes at discharge and 6 months. DISCUSSION: This trial will determine the effectiveness of sub-dissociative ketamine infusion as part of a MMPR in reducing in-hospital opioid exposure in adult trauma patients. Furthermore, it will inform decisions regarding acute pain strategies on patient centered outcomes. TRIAL REGISTRATION: The Ketamine for Acute Pain Management After Trauma (KAPT) with registration # NCT04129086 was registered on October 16, 2019. BioMed Central 2022-07-27 /pmc/articles/PMC9326146/ /pubmed/35897081 http://dx.doi.org/10.1186/s13063-022-06511-6 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Study Protocol Puzio, Thaddeus J. Klugh, James Wandling, Michael W. Green, Charles Balogh, Julius Prater, Samuel J. Stephens, Christopher T. Sergot, Paulina B. Wade, Charles E. Kao, Lillian S. Harvin, John A. Ketamine for acute pain after trauma: the KAPT randomized controlled trial |
title | Ketamine for acute pain after trauma: the KAPT randomized controlled trial |
title_full | Ketamine for acute pain after trauma: the KAPT randomized controlled trial |
title_fullStr | Ketamine for acute pain after trauma: the KAPT randomized controlled trial |
title_full_unstemmed | Ketamine for acute pain after trauma: the KAPT randomized controlled trial |
title_short | Ketamine for acute pain after trauma: the KAPT randomized controlled trial |
title_sort | ketamine for acute pain after trauma: the kapt randomized controlled trial |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9326146/ https://www.ncbi.nlm.nih.gov/pubmed/35897081 http://dx.doi.org/10.1186/s13063-022-06511-6 |
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