Brain Injury and Ketamine study (BIKe): a prospective, randomized controlled double blind clinical trial to study the effects of ketamine on therapy intensity level and intracranial pressure in severe traumatic brain injury patients.
Trials May 28, 2025 Veerle De Sloovere, Liese Mebis, Pieter Wouters et al. 9 citations
Ketamine, a sedative and analgesic, has been avoided in severe traumatic brain injury (TBI) due to a precaution about raising intracranial pressure (ICP). Observational studies and two meta-analyses do not suggest that ketamine increases ICP in sedated, mechanically ventilated TBI patients. The Brain Injury and Ketamine (BIKe) study is a planned prospective, multicenter, double-blind, placebo-controlled randomized trial. It will test whether adding ketamine (1 mg/kg/h continuous infusion) to standard sedation in 100 adult ICU patients with severe TBI is safe and reduces the need for other therapies to control ICP. The primary safety endpoint is the median number of high ICP episodes per ICU stay.