Adjusting perioperative methadone dose for elderly and fragile hip fracture patients (MetaHip-trial) – A statistical analysis plan for an adaptive dose-finding trial
Background: The elderly population is expanding globally. This gives numerous challenges especially regarding hip fracture patients. In the US alone over 300.000 hip fracture patients are treated each year, and a large amount of those develop opoid addiction. Hip fractures require surgical intervent...
| Main Authors: | , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Elsevier
2023-12-01
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| Series: | Contemporary Clinical Trials Communications |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2451865423001746 |
| _version_ | 1797389386669621248 |
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| author | Andreas Kristian Pedersen Kevin Heebøll Nygaard Sofie Ronja Petersen Kirsten Specht Thomas Strøm Caroline Margaret Moos Helene Skjøt-Arkil Jesper Ougaard Schønnemann |
| author_facet | Andreas Kristian Pedersen Kevin Heebøll Nygaard Sofie Ronja Petersen Kirsten Specht Thomas Strøm Caroline Margaret Moos Helene Skjøt-Arkil Jesper Ougaard Schønnemann |
| author_sort | Andreas Kristian Pedersen |
| collection | DOAJ |
| description | Background: The elderly population is expanding globally. This gives numerous challenges especially regarding hip fracture patients. In the US alone over 300.000 hip fracture patients are treated each year, and a large amount of those develop opoid addiction. Hip fractures require surgical intervention within 24 h and is associated with significant pain even at rest. Postoperative analgesic treatment need to be optimized to ensure adequate pain relief and to prevent subsequent opioid addiction. Previous studies have shown that methadone effectively decreases post-operative opioid consumption but the studies focused on younger patients undergoing elective surgery. This study focus on the use of methadone on the elderly, fragile patients undergoing acute surgery, by first determining the maximal tolerable dose.The hypothesis is the maximal tolerable doses of these hip-fracture patients lies between 0.10 mg/kg and 0.20 mg/kg. This trial aims to estimate the maximum tolerable dose of methadone when administered to elderly patients undergoing surgery for a hip fracture. Method: This project is an adaptive dose-finding trial. The continuous reassessment method will estimate the maximum tolerable dose of methadone. The primary outcome will be respiratory depression. The statistical analysis plan will be published a priori to the closure of patient recruitment and statistical analysis of database results. Conclusion: The results of this study will give valuable information about the maximally tolerated dose of methadone for postoperative pain relief for elderly patients with hip fractures and potential adverse events.This trial is registered on clinicaltrials.gov with trial registration: NCT05581901. Registered 17 October 2022, https://www.clinicaltrials.gov/ct2/show/NCT05581901?term=methadone&cond = hip&draw = 2&rank = 1. |
| first_indexed | 2024-03-08T22:56:12Z |
| format | Article |
| id | doaj.art-0c3fa6054eaa4162a3a554a5ef0e3177 |
| institution | Directory Open Access Journal |
| issn | 2451-8654 |
| language | English |
| last_indexed | 2024-03-08T22:56:12Z |
| publishDate | 2023-12-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Contemporary Clinical Trials Communications |
| spelling | doaj.art-0c3fa6054eaa4162a3a554a5ef0e31772023-12-16T06:08:38ZengElsevierContemporary Clinical Trials Communications2451-86542023-12-0136101228Adjusting perioperative methadone dose for elderly and fragile hip fracture patients (MetaHip-trial) – A statistical analysis plan for an adaptive dose-finding trialAndreas Kristian Pedersen0Kevin Heebøll Nygaard1Sofie Ronja Petersen2Kirsten Specht3Thomas Strøm4Caroline Margaret Moos5Helene Skjøt-Arkil6Jesper Ougaard Schønnemann7Department of Clinical Research, University Hospital of Southern Denmark, Kresten Phillipsens vej, Aabenraa, DenmarkDepartment of Clinical Research, University Hospital of Southern Denmark, Kresten Phillipsens vej, Aabenraa, Denmark; Department of Orthopedics, University Hospital of Southern Denmark, Kresten Phillipsens vej, Aabenraa, Denmark; Corresponding author. Department of Orthopedics, University Hospital of Southern Denmark, Kresten Phillipsens vej, Aabenraa, Denmark.Department of Clinical Research, University Hospital of Southern Denmark, Kresten Phillipsens vej, Aabenraa, DenmarkCenter for COPD, Center for Health and Rehabilitation, Randersgade 60, 2100, København Ø, DenmarkDepartment of Anesthesiology and Intensive Care, University Hospital of Southern Denmark, Kresten Philipsens vej 15, 6200, Aabenraa, DenmarkDepartment of Clinical Research, University Hospital of Southern Denmark, Kresten Phillipsens vej, Aabenraa, DenmarkDepartment of Clinical Research, University Hospital of Southern Denmark, Kresten Phillipsens vej, Aabenraa, Denmark; Emergency Department, University Hospital of Southern Denmark, Kresten Phillipsens vej, Aabenraa, DenmarkDepartment of Orthopedics, University Hospital of Southern Denmark, Kresten Phillipsens vej, Aabenraa, DenmarkBackground: The elderly population is expanding globally. This gives numerous challenges especially regarding hip fracture patients. In the US alone over 300.000 hip fracture patients are treated each year, and a large amount of those develop opoid addiction. Hip fractures require surgical intervention within 24 h and is associated with significant pain even at rest. Postoperative analgesic treatment need to be optimized to ensure adequate pain relief and to prevent subsequent opioid addiction. Previous studies have shown that methadone effectively decreases post-operative opioid consumption but the studies focused on younger patients undergoing elective surgery. This study focus on the use of methadone on the elderly, fragile patients undergoing acute surgery, by first determining the maximal tolerable dose.The hypothesis is the maximal tolerable doses of these hip-fracture patients lies between 0.10 mg/kg and 0.20 mg/kg. This trial aims to estimate the maximum tolerable dose of methadone when administered to elderly patients undergoing surgery for a hip fracture. Method: This project is an adaptive dose-finding trial. The continuous reassessment method will estimate the maximum tolerable dose of methadone. The primary outcome will be respiratory depression. The statistical analysis plan will be published a priori to the closure of patient recruitment and statistical analysis of database results. Conclusion: The results of this study will give valuable information about the maximally tolerated dose of methadone for postoperative pain relief for elderly patients with hip fractures and potential adverse events.This trial is registered on clinicaltrials.gov with trial registration: NCT05581901. Registered 17 October 2022, https://www.clinicaltrials.gov/ct2/show/NCT05581901?term=methadone&cond = hip&draw = 2&rank = 1.http://www.sciencedirect.com/science/article/pii/S2451865423001746ElderlyFragilePostoperativePainPerioperativeDose finding |
| spellingShingle | Andreas Kristian Pedersen Kevin Heebøll Nygaard Sofie Ronja Petersen Kirsten Specht Thomas Strøm Caroline Margaret Moos Helene Skjøt-Arkil Jesper Ougaard Schønnemann Adjusting perioperative methadone dose for elderly and fragile hip fracture patients (MetaHip-trial) – A statistical analysis plan for an adaptive dose-finding trial Contemporary Clinical Trials Communications Elderly Fragile Postoperative Pain Perioperative Dose finding |
| title | Adjusting perioperative methadone dose for elderly and fragile hip fracture patients (MetaHip-trial) – A statistical analysis plan for an adaptive dose-finding trial |
| title_full | Adjusting perioperative methadone dose for elderly and fragile hip fracture patients (MetaHip-trial) – A statistical analysis plan for an adaptive dose-finding trial |
| title_fullStr | Adjusting perioperative methadone dose for elderly and fragile hip fracture patients (MetaHip-trial) – A statistical analysis plan for an adaptive dose-finding trial |
| title_full_unstemmed | Adjusting perioperative methadone dose for elderly and fragile hip fracture patients (MetaHip-trial) – A statistical analysis plan for an adaptive dose-finding trial |
| title_short | Adjusting perioperative methadone dose for elderly and fragile hip fracture patients (MetaHip-trial) – A statistical analysis plan for an adaptive dose-finding trial |
| title_sort | adjusting perioperative methadone dose for elderly and fragile hip fracture patients metahip trial a statistical analysis plan for an adaptive dose finding trial |
| topic | Elderly Fragile Postoperative Pain Perioperative Dose finding |
| url | http://www.sciencedirect.com/science/article/pii/S2451865423001746 |
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