Adjusting perioperative methadone dose for elderly and fragile hip fracture patients (MetaHip-trial): A statistical analysis plan for an adaptive dose-finding trial

Andreas Kristian Pedersen, Kevin Heebøll Nygaard*, Sofie Ronja Petersen, Kirsten Specht, Thomas Strøm, Caroline Margaret Moos, Helene Skjøt-Arkil, Jesper Ougaard Schønnemann

*Kontaktforfatter

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

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Abstract

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.

OriginalsprogEngelsk
Artikelnummer101228
TidsskriftContemporary Clinical Trials Communications
Vol/bind36
Antal sider7
ISSN2451-8654
DOI
StatusUdgivet - dec. 2023

Bibliografisk note

Funding Information:
Material costs are covered by grants from The A.P. Møller and Chastine Mc-Kinney Møller Foundation (grant number L-2022-00365 ) and Knud and Edith Eriksens memorial foundation (grant number 62786–2023 ). Investigator salary is covered by grants from The University Hospital of Southern Denmark (Kresten Philipsensvej 15, 6200 Aabenraa, Denmark;shs.kontakt@rsyd.dk ) (grant number 22/25,256 ) and the Region of southern Denmark (grant number 22/26,251 ).

Publisher Copyright:
© 2023 The Authors

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