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Ketamine Sedation in the ICU (KANINE) RCT

RecruitingPhase 3Ages 18 Years - anyAllMcMaster University
NCT06767358 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Sedation is given to intensive care unit (ICU) patients to treat discomfort, anxiety, agitation, and to help facilitate care, particularly when they require a breathing tube. Sedation is very commonly used in the ICU with North American data showing almost 40% of ICU patients get sedation to help when they are requiring a breathing machine. Various medications can be given intravenously to provide sedation in the ICU but there are side-effects associated with each such as decreasing a patient's own drive to breathe, and delirium or acute confusion, both of which are associated with worse outcomes. Also, most drugs used for sedation don't treat pain. As a result, many ICU patients are also given narcotics for pain control which can result in tolerance, dependence, and withdrawal. Ketamine is a sedating medication that also treats pain and is often used in the Emergency Department and in t

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📋 Eligibility rules (as published)
Inclusion Criteria: * Adult patients (≥ 18 years) admitted to the ICU * Receiving invasive mechanical ventilation and expected to remain mechanically ventilated beyond the calendar day after randomization * Mechanically ventilated for fewer than 3 days * Receiving any non-ketamine continuous sedative infusion Exclusion Criteria: * Admitted with a primary diagnosis of intracranial hemorrhage, traumatic brain injury, or stroke * Admitted with uncontrolled hypertension (SBP/DBP \> 180/100mmHg) * Status asthmaticus * Admitted to the ICU with partial thickness burns \> 10% total body surface area or any full thickness burns * Schizophrenia * End-stage Liver Failure (Child-Pugh C) * Requiring an equivalent of norepinephrine at a dose ≥1mcg/kg/min * Undergoing palliation or comfort care * On neuromuscular blocking agent * Pre-existing tracheostomy * Hypersensitivity to Ketamine * Liver transplantation in the last month * Pregnant or breast-feeding
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What it tests

  • ketamine hydrochloride
  • Normal saline placebo
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Where

3 sites
St. Joseph's Healthcare Hamilton
Hamilton, Canada
Hamilton Health Sciences
Hamilton, Canada
Mount Sinai Hospital
Toronto, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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