A Randomized, Double-Blind Study of Placebo vs. Ketamine For Use During Dressing Changes in Critically Ill Burn Patients
Thermal Hyperalgesia, Anxiety, Pain
About this trial
This is an interventional treatment trial for Thermal Hyperalgesia
Eligibility Criteria
Inclusion Criteria:
- ≥ 5% TBSA
- Dressing changes planned to be completed in the burn treatment room
- Approval from the attending physician
Exclusion Criteria:
- Inhalation injury
- Electrical injury
- Patients requiring mechanical ventilation during dressing changes
- Previous diagnosis of PTSD
- Systolic blood pressure exceeding 180 mmHg within six hours of the planned dressing change unrelated to pain or anxiety
- Patients <18 or >89 years of age
- Patient pending transfer to another facility
- Patients with known or suspected severe adverse reactions to ketamine
- Patients who have already participated (i.e. previously randomized) and are readmitted to an ICU after being discharged from UCH
- Prisoners
- Pregnant females or suspected of being pregnant
- Unable to comprehend informed consent process or denial of informed consent
Sites / Locations
- University of Colorado
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Ketamine
Placebo
Ketamine 50mg/1mL will be diluted with 9mL of normal saline to create 50mg in the 10mL syringe. Administered twice via intravenous administration; the first dose 10 minutes prior to the dressing change and a second dose 20-30 minutes into the dressing change procedure. The study will provide study drug for up to five dressing change procedures (i.e. ten total doses).
Placebo will be 10mL of normal saline in the syringe. Administered twice via intravenous administration; the first dose 10 minutes prior to the dressing change and a second dose 20-30 minutes into the dressing change procedure. The study will provide study drug for up to five dressing change procedures (i.e. ten total doses).