Ketamine for acute pain after trauma: the KAPT randomized controlled trial

Abstract 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...

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Main Authors: Thaddeus J. Puzio, James Klugh, Michael W. Wandling, Charles Green, Julius Balogh, Samuel J. Prater, Christopher T. Stephens, Paulina B. Sergot, Charles E. Wade, Lillian S. Kao, John A. Harvin
Format: Article
Language:English
Published: BMC 2022-07-01
Series:Trials
Subjects:
Online Access:https://doi.org/10.1186/s13063-022-06511-6
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author Thaddeus J. Puzio
James Klugh
Michael W. Wandling
Charles Green
Julius Balogh
Samuel J. Prater
Christopher T. Stephens
Paulina B. Sergot
Charles E. Wade
Lillian S. Kao
John A. Harvin
author_facet Thaddeus J. Puzio
James Klugh
Michael W. Wandling
Charles Green
Julius Balogh
Samuel J. Prater
Christopher T. Stephens
Paulina B. Sergot
Charles E. Wade
Lillian S. Kao
John A. Harvin
author_sort Thaddeus J. Puzio
collection DOAJ
description Abstract 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.
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spelling doaj.art-16d018459f65429cae9010c40dfde4a12022-12-22T03:40:30ZengBMCTrials1745-62152022-07-012311810.1186/s13063-022-06511-6Ketamine for acute pain after trauma: the KAPT randomized controlled trialThaddeus J. Puzio0James Klugh1Michael W. Wandling2Charles Green3Julius Balogh4Samuel J. Prater5Christopher T. Stephens6Paulina B. Sergot7Charles E. Wade8Lillian S. Kao9John A. Harvin10Department of Surgery, McGovern Medical School at UTHealth, The University of TexasDepartment of Surgery, McGovern Medical School at UTHealth, The University of TexasDepartment of Surgery, McGovern Medical School at UTHealth, The University of TexasCenter for Clinical Research and Evidence Based Medicine, McGovern Medical School at UTHealthDepartment of Anesthesia, University of Arkansas for Medical SciencesDepartment of Emergency Medicine, The University of Texas Medical Center at HoustonDepartment of Anesthesiology, McGovern Medical School at UTHealthDepartment of Emergency Medicine, The University of Texas Medical Center at HoustonCenter for Translational Injury Research, Department of Surgery, McGovern Medical School at UTHealthDepartment of Surgery, McGovern Medical School at UTHealth, The University of TexasDepartment of Surgery, McGovern Medical School at UTHealth, The University of TexasAbstract 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.https://doi.org/10.1186/s13063-022-06511-6KetamineMultimodal pain controlAnalgesia
spellingShingle Thaddeus J. Puzio
James Klugh
Michael W. Wandling
Charles Green
Julius Balogh
Samuel J. Prater
Christopher T. Stephens
Paulina B. Sergot
Charles E. Wade
Lillian S. Kao
John A. Harvin
Ketamine for acute pain after trauma: the KAPT randomized controlled trial
Trials
Ketamine
Multimodal pain control
Analgesia
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 Ketamine
Multimodal pain control
Analgesia
url https://doi.org/10.1186/s13063-022-06511-6
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