European journal of anaesthesiology
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Randomized Controlled Trial
The novel rapid formulation of intravenous dantrolene (NPJ5008) versus standard dantrolene (DANTRIUM IV): A clinical part-randomised phase 1 study in healthy volunteers.
Delays in treating anaesthesia-induced malignant hyperthermia increase risks of complications and death. NPJ5008 is a novel formulation of the indicated treatment, dantrolene sodium, developed to shorten preparation and administration times compared with the reference formulation Dantrium®. The two formulations have been compared preclinically. ⋯ NPJ5008 showed comparable pharmacokinetic and safety profiles to Dantrium®, while reducing dantrolene dose preparation/administration times, potentially reducing patient complications/healthcare resourcing in malignant hyperthermia.