None listed
Conditions
Brief summary
Most ICU patients who need a breathing machine (ventilator) to help them breathe require sedation and pain relief with one or more sedative (calming) and analgesic (pain reliever) drugs given as continuous drip into a vein. Combinations of sedative and analgesic drugs are usually used in the ICU to make patients on ventilators comfortable. The focus of this study is on the analgesic component of this management. Analgesic drugs will treat a patient’s pain, but may also provide some sedation. The type and the manner in which analgesic agents are used will vary. The type of analgesic drug and the way they are given may determine whether or not a patient is deeply or lightly sedated (more or less responsive to voice or physical stimulation). Currently, there is no agreement amongst doctors around the world about the best choice of analgesic drug or the best way to manage pain in patients receiving mechanical ventilation. Many of the commonly used analgesic drugs have side effects and may be associated with longer time on the ventilator, longer stay in the ICU, leading to delirium (a confused state often including hallucinations) and decreased mental awareness after recovery from critical illness. Clinical guidelines recommend a multi-modal approach to pain relief in patients who are being treated with a breathing machine (mechanical ventilation). This approach is to try and minimise the amount of pure analgesic agents used and theoretically minimise side effects of these agents. The purpose of this study is to evaluate a drug which has both analgesic and sedative properties, ketamine (Ketalar®), that might decrease the need for other analgesic agents and improve survival and recovery (reduce delirium, time on a ventilator and time in ICU) for patients who are receiving mechanical ventilation in the ICU.
Interventions
Ketamine HCl (200mg/2ml) will be mixed with 98ml 0.9% NaCl for a final concentration of 2mg/ml of active ketamine in 100ml infusion flask.
Patients will receive approximately 0.15 mg/kg/hr (0.075 ml/kg/hr) actual body weight (to a maximum equivalence of 100kg or 15 mg/hr) via continuous intravenous infusion while they are receiving an opioid infusion and are mechanically ventilated in the intensive care unit.
Trial medication will be infused while the patient is receiving an opioid infusion.
Ketamine HCl (200mg/2ml) will be mixed with 98ml 0.9% NaCl for a final concentration of 2mg/ml of active ketamine in 100ml infusion flask. Patients will receive approximately 0.15 mg/kg/hr (0.075 ml/kg/hr) actual body weight (to a maximum equivalence of 100kg or 15 mg/hr) via continuous intravenous infusion while they are receiving an opioid infusion and are mechanically ventilated in the intensive care unit. Trial medication will be infused while the patient is receiving an opioid infusion. If opioid infusion is stopped: - weaning or ceasing of study drug is a clinical decision - study drug can continue while patient is intubated + post extubation - study drug must be weaned within 12hrs following extubation Adherence will be monitored via audit of medication charts, electronic medical records or observation charts.
Sponsors
Austin Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
Equal to or greater than 18 years of age Mechanically ventilated at the time of assessment for eligibility Opioid medication infusion prescribed by treating intensive care unit physician Enrolment to occur within the first 12 hours of intensive care unit admission
Exclusion criteria
Cardiac surgical patients Previous adverse reaction to ketamine Equal to or older than 80 years of age Pregnancy or lactation Uncontrolled hypertension defined as systolic blood pressure of greater than 180 millimeters of mercury Uncontrolled heart failure Patients admitted to intensive care for end-of-life care or to facilitate organ donation Previous enrolment in the KALME trial No legal surrogate identified or able to provide informed consent to continue for patient
Outcome results
None listed