Randomised controlled trial of analgesia for the management of acute severe pain from traumatic injury: study protocol for the paramedic analgesia comparing ketamine and morphine in trauma (PACKMaN)
<p><strong>Background</strong> Prehospital analgesia is often required after traumatic injury, currently morphine is the strongest parenteral analgesia routinely available for use by paramedics in the United Kingdom (UK) when treating patients with severe pain. This protocol descri...
| Main Authors: | , , , , , , , , , , , , , |
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| Format: | Journal article |
| Language: | English |
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BioMed Central
2023
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| _version_ | 1797111765794816000 |
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| author | Michelet, F Smyth, M Lall, R Noordali, H Starr, K Berridge, L Yeung, J Fuller, G Petrou, S Walker, A Mark, J Canaway, A Khan, K Perkins, GD |
| author_facet | Michelet, F Smyth, M Lall, R Noordali, H Starr, K Berridge, L Yeung, J Fuller, G Petrou, S Walker, A Mark, J Canaway, A Khan, K Perkins, GD |
| author_sort | Michelet, F |
| collection | OXFORD |
| description | <p><strong>Background</strong> Prehospital analgesia is often required after traumatic injury, currently morphine is the strongest parenteral analgesia routinely available for use by paramedics in the United Kingdom (UK) when treating patients with severe pain. This protocol describes a multi-centre, randomised, double blinded trial comparing the clinical and cost-effectiveness of ketamine and morphine for severe pain following acute traumatic injury.</p>
<p><strong>Methods</strong> A two arm pragmatic, phase III trial working with two large NHS ambulance services, with an internal pilot. Participants will be randomised in equal numbers to either (1) morphine or (2) ketamine by IV/IO injection. We aim to recruit 446 participants over the age of 16 years old, with a self-reported pain score of 7 or above out of 10. Randomised participants will receive a maximum of 20 mg of morphine, or a maximum of 30 mg of ketamine, to manage their pain. The primary outcome will be the sum of pain intensity difference. Secondary outcomes measure the effectiveness of pain relief and overall patient experience from randomisation to arrival at hospital as well as monitoring the adverse events, resource use and cost-effectiveness outcomes.</p>
<p><strong>Discussion</strong> The PACKMAN study is the first UK clinical trial addressing the clinical and cost-effectiveness of ketamine and morphine in treating acute severe pain from traumatic injury treated by NHS paramedics. The findings will inform future clinical practice and provide insights into the effectiveness of ketamine as a prehospital analgesia.<br>
<i>Trial registration:</i> ISRCTN, ISRCTN14124474. Registered 22 October 2020, https://www.isrctn.com/ISRCTN14124474</p> |
| first_indexed | 2024-03-07T08:14:59Z |
| format | Journal article |
| id | oxford-uuid:ff620ce9-5dd1-40d2-a014-c8e34d4e8596 |
| institution | University of Oxford |
| language | English |
| last_indexed | 2024-03-07T08:14:59Z |
| publishDate | 2023 |
| publisher | BioMed Central |
| record_format | dspace |
| spelling | oxford-uuid:ff620ce9-5dd1-40d2-a014-c8e34d4e85962023-12-13T11:16:09ZRandomised controlled trial of analgesia for the management of acute severe pain from traumatic injury: study protocol for the paramedic analgesia comparing ketamine and morphine in trauma (PACKMaN)Journal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:ff620ce9-5dd1-40d2-a014-c8e34d4e8596EnglishSymplectic ElementsBioMed Central2023Michelet, FSmyth, MLall, RNoordali, HStarr, KBerridge, LYeung, JFuller, GPetrou, SWalker, AMark, JCanaway, AKhan, KPerkins, GD<p><strong>Background</strong> Prehospital analgesia is often required after traumatic injury, currently morphine is the strongest parenteral analgesia routinely available for use by paramedics in the United Kingdom (UK) when treating patients with severe pain. This protocol describes a multi-centre, randomised, double blinded trial comparing the clinical and cost-effectiveness of ketamine and morphine for severe pain following acute traumatic injury.</p> <p><strong>Methods</strong> A two arm pragmatic, phase III trial working with two large NHS ambulance services, with an internal pilot. Participants will be randomised in equal numbers to either (1) morphine or (2) ketamine by IV/IO injection. We aim to recruit 446 participants over the age of 16 years old, with a self-reported pain score of 7 or above out of 10. Randomised participants will receive a maximum of 20 mg of morphine, or a maximum of 30 mg of ketamine, to manage their pain. The primary outcome will be the sum of pain intensity difference. Secondary outcomes measure the effectiveness of pain relief and overall patient experience from randomisation to arrival at hospital as well as monitoring the adverse events, resource use and cost-effectiveness outcomes.</p> <p><strong>Discussion</strong> The PACKMAN study is the first UK clinical trial addressing the clinical and cost-effectiveness of ketamine and morphine in treating acute severe pain from traumatic injury treated by NHS paramedics. The findings will inform future clinical practice and provide insights into the effectiveness of ketamine as a prehospital analgesia.<br> <i>Trial registration:</i> ISRCTN, ISRCTN14124474. Registered 22 October 2020, https://www.isrctn.com/ISRCTN14124474</p> |
| spellingShingle | Michelet, F Smyth, M Lall, R Noordali, H Starr, K Berridge, L Yeung, J Fuller, G Petrou, S Walker, A Mark, J Canaway, A Khan, K Perkins, GD Randomised controlled trial of analgesia for the management of acute severe pain from traumatic injury: study protocol for the paramedic analgesia comparing ketamine and morphine in trauma (PACKMaN) |
| title | Randomised controlled trial of analgesia for the management of acute severe pain from traumatic injury: study protocol for the paramedic analgesia comparing ketamine and morphine in trauma (PACKMaN) |
| title_full | Randomised controlled trial of analgesia for the management of acute severe pain from traumatic injury: study protocol for the paramedic analgesia comparing ketamine and morphine in trauma (PACKMaN) |
| title_fullStr | Randomised controlled trial of analgesia for the management of acute severe pain from traumatic injury: study protocol for the paramedic analgesia comparing ketamine and morphine in trauma (PACKMaN) |
| title_full_unstemmed | Randomised controlled trial of analgesia for the management of acute severe pain from traumatic injury: study protocol for the paramedic analgesia comparing ketamine and morphine in trauma (PACKMaN) |
| title_short | Randomised controlled trial of analgesia for the management of acute severe pain from traumatic injury: study protocol for the paramedic analgesia comparing ketamine and morphine in trauma (PACKMaN) |
| title_sort | randomised controlled trial of analgesia for the management of acute severe pain from traumatic injury study protocol for the paramedic analgesia comparing ketamine and morphine in trauma packman |
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