The intranasal dexmedetomidine plus ketamine for procedural sedation in children, adaptive randomized controlled non-inferiority multicenter trial (Ketodex): a statistical analysis plan

The intranasal dexmedetomidine plus ketamine for procedural sedation in children, adaptive randomized controlled non-inferiority multicenter trial (Ketodex): a statistical analysis plan

Abstract Background Procedural sedation and analgesia (PSA) is frequently required to perform closed reductions for fractures and dislocations in children. Intravenous (IV) ketamine is the most commonly used sedative agent for closed reductions. However, as children find IV insertion a distressing a...

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Bibliographic Details
Main Authors: Anna Heath, Juan David Rios, Eleanor Pullenayegum, Petros Pechlivanoglou, Martin Offringa, Maryna Yaskina, Rick Watts, Shana Rimmer, Terry P. Klassen, Kamary Coriolano, Naveen Poonai, on behalf of the PERC-KIDSCAN Ketodex Study Group
Format: Article
Language:English
Published: BMC 2021-01-01
Series:Trials
Subjects:
Procedural sedation and analgesia
Pediatric closed reduction
Intranasal ketodex
Non-inferiority trial
Bayesian adaptive design
Statistical analysis plan
Online Access:https://doi.org/10.1186/s13063-020-04946-3

Internet

https://doi.org/10.1186/s13063-020-04946-3

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