A Randomized, Double-Blind Study of Placebo vs. Ketamine For Use During Dressing Changes in Critically Ill Burn Patients
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Pain levels before, during, and after dressing changes between placebo and ketamine.
研究概览
简要总结
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.
详细描述
Research Methods
A. Outcome Measure(s):
This is a randomized, double-blind study designed to evaluate the effectiveness of ketamine versus placebo in addition to usual care used during dressing changes in 30 thermally injured subjects. The primary outcomes are the opioid and benzodiazepine requirements surrounding dressing changes, pain profiles, hemodynamic changes, and pain-related anxiety scores related to ketamine use versus placebo. Secondary outcomes are exploratory and will evaluate the inflammatory markers, IL-1β and IL-6, and their presence in regards to ketamine versus placebo as well as their associations with ASD, depression, and PTSD.
B. Description of Population to be Enrolled:
The study methodology will follow the CONSORT guidelines. A total of 30 critically ill burn patients with a total body surface area (TBSA) ≥ 5% requiring dressing changes that will be performed in the hydro procedure room will be enrolled over 18-24 months from the 9-bed burn-trauma ICU (B-TICU) at the UCH. Patients will only be enrolled if they can receive dressing changes in the burn treatment room because these patients are alert and oriented, not sedated, and are able to communicate with health care providers and respond to questions regarding their perceptions of pain and anxiety. Subjects will be randomized in a double-blind manner to receive placebo (n=15) or ketamine (n=15) in addition to usual care used before, during, and after dressing changes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Dressing changes planned to be completed in the burn treatment room
- •Approval from the attending physician
排除标准
- •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
- •Pregnant females or suspected of being pregnant
- •Unable to comprehend informed consent process or denial of informed consent
研究组 & 干预措施
Ketamine
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).
干预措施: Ketamine (Drug)
Placebo
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).
干预措施: Placebo, Normal Saline (Drug)
结局指标
主要结局
Pain levels before, during, and after dressing changes between placebo and ketamine.
时间窗: Four hours
When a subject is scheduled for a dressing change in the burn treatment room, the subject will be asked to rate their pain score using the Visual Analogue Scale (VAS) \[anchored by 0 representing no pain and 10 being the worst pain the patient has ever experienced\]. The VAS instrument will be administered by the investigator or designee within 4-12 hours prior to the dressing change procedure. Subjects will then be asked to rate their pain using the VAS within 4-12 hours after the end of the procedure. This will be repeated for every dressing change.
Opioid and benzodiazepine requirements before, during, and after dressing changes between placebo and ketamine
时间窗: Four hours
When a subject is scheduled for a dressing change in the burn treatment room, the subject's active medication list will be evaluated for analgesic, anxiolytic, and neuropathic medications. Every hour, starting 4 hours prior to the beginning of the dressing change procedure, each drug, dose, and route will be recorded for administered medications. Opioid medications will be converted to fentanyl equivalents and benzodiazepine medications will be converted to midazolam equivalents as fentanyl and midazolam represent the most commonly administered agents. Documentation will continue every hour up to 4 hours after the end of the procedure. This will be repeated for every dressing change.
次要结局
- The incidence of PTSD between placebo and ketamine after dressing changes.(Before hospital discharge, anticipated to be three days before)
- Evaluate the magnitude of change in serum concentrations of IL-1β and IL-6 levels during dressing changes between placebo and ketamine.(4-12 hours)
- The incidence of ASD between placebo and ketamine after dressing changes.(7 days after dressing changes are complete)
- Pain-related anxiety surrounding dressing changes between placebo and ketamine.(4-12 hours)
- The occurrence of hypo- or hypertension, tachycardia, neurologic agitation / disassociation, over-sedation, and the need for open-label ketamine between placebo and ketamine.(Four hours)
- The incidence of depression between placebo and ketamine after dressing changes.(Before hospital discharge, anticipated to be three days before)