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Published in: Trials 1/2022

Open Access 01-12-2022 | Opioids | Study protocol

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

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

Published in: Trials | Issue 1/2022

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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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Metadata
Title
Ketamine for acute pain after trauma: the KAPT randomized controlled trial
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
Publication date
01-12-2022
Publisher
BioMed Central
Published in
Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-022-06511-6

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