A Randomized, Double-Blind Study of Placebo vs. Ketamine For Use During Dressing Changes in Critically Ill Burn Patients
Withdrawn before enrolling · Phase 4 · Has a placebo group
Conditions studied: Thermal Hyperalgesia, Anxiety, Pain
In brief
Burn-related pain is severe and often difficult to manage. Healthcare workers struggle with keeping burn patients comfortable, especially when these patients undergo dressing changes of their burn wounds of their skin since these procedures often cause severe pain. Patients with burn wounds frequently require high doses of opioids (narcotics) and calming (anxiolytic) agents to the extent that clinicians must weigh the risks associated with these doses against achieving adequate analgesia and comfort. The biggest risk is over-sedation to cause breathing troubles. Inadequate pain control during these procedures heightens pain perception, anxiety, and fear surrounding the experience and may lead to patients experiencing additional psychological disorders like depression, acute stress disorder (ASD), and post-traumatic stress disorder (PTSD). Therefore, therapeutic options for better management of pain and anxiety during these procedures need to be identified. This study will address whether the addition of ketamine during dressing changes improves patients' pain control and comfort and whether this leads to favorable psychological outcomes. The study is designed to compare ketamine with placebo when they are added to usual care (opioids and anxiolytics) during dressing changes. The main outcomes of the study will be the amount of opioid and anxiolytic agents each group receives during their procedure; the presence of pain-related anxiety shortly after the procedures; blood markers of stress during the procedures; and the presence of depression, anxiety and stress disorders prior to discharge. This study will assess whether the early administration of ketamine reduces pain and anxiety to prevent the need for high doses of opioids and anxiolytics. A total of 30 patients will be enrolled.
Key facts
- Study ID
- NCT02336308
- Run by
- University of Colorado, Denver
- People needed
- 0
- Starts
- 2015-01-01
- Expected to finish
- 2015-01-01
- Last updated by the study team
- 2015-11-26
Who can join
Age: 18 and older, up to 89. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- ≥ 5% TBSA
- Dressing changes planned to be completed in the burn treatment room
- Approval from the attending physician
You may not qualify if…
- 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
Where it is running
- University of Colorado — Aurora, Colorado, United States
Full record on ClinicalTrials.gov
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