Analgesic Effect of Esketamine in Dressing Change for Severe Burns in Adults: a Prospective Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 52
- 主要终点
- The dosage of the remedy fentanyl
研究概览
简要总结
Patients with severe and above degree burns are often complicated with inhalation injury and systemic infection. During debridement and dressing change in such patients, doctors will be more cautious in using analgesics. Patients often moan, shiver and limb movement due to insufficient sedation and analgesia, resulting in unpleasant feelings and experiences, which increases the anxiety of patients during hospitalization. Previous studies have shown that the use of ketamine in burn patients during dressing change can produce good analgesia and maintain stable vital signs.
Esketamine, the dextral monomer of ketamine, has hypnotic, sedative and analgesic effects and could be safely used in clinical anesthesia. Compared with ketamine, esketamine has stronger analgesic efficacy and less circulatory influence, which is more consistent with the characteristics of ideal analgesic drugs in burn dressing. As an FDA-approved drug for the treatment of refractory depression, esketamine has potential social benefits in burn patients due to its rapid antidepressant pharmacological properties. This study hypothesized that esketamine could reduce the pain of dressing change in patients with severe burns and reduce the occurrence of early depression in such patients.
This study adopted a prospective, double-blind, randomized, controlled, single-center design. A total of 52 severe burn patients aged 18-60 years who need debridement and dressing change under sedation and analgesia were included and randomly divided into the experiment group: esketamine would be used in the induction phase; the control group: esketamine would not be used in the induction phase. Both groups were given dexmedetomidine and butofinol before induction, and fentanyl as a remedy during the dressing change phase. The dosage of fentanyl in the dressing change phase, the pain score (SF-MPQ) after recovery, the incidence of sedation-related complication were compared between the two groups.
This study explores the advantages of esketamine in reducing the use of opioids and the pain score of patients.
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)
盲法说明
This study was double-blind, including subjects, anesthesia operators, data collectors and dressing change operators. Nurse Song Yi opened the random envelope, diluted the drugs with normal saline according to the grouping information and filled them into a 10ml syringe. The syringe was labeled (marked with subject number, name and hospitalization number), and the grouping information was destroyed after confirmation, and confidentiality was strictly observed. Fully equipped drugs are given to the anesthesiologist and empty envelopes are given to the data collector.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) Grades II to IV
- •Patients with severe degree burns Ages 18 to 60
- •Patients who signed informed consent forms
排除标准
- •Hepatic and renal insufficiency
- •Allergy to intended medication
- •History of antidepressant or antipsychotic drug use
- •Atrioventricular block of second degree or higher
- •Patients who can't cooperate
研究组 & 干预措施
EsKetamine Group
The "Esketamine" was administered intravenously at 0.1mg per kilogram of body weight 1min before the dressing change.
Esketamine Hydrochloride Injection 2ml：50mg
干预措施: Esketamine 0.1mg/kg intravenous injection (Drug)
Control Group
干预措施: Normal saline (Drug)
结局指标
主要结局
The dosage of the remedy fentanyl
时间窗: Within 5 minutes after the dressing change
Observe the dose of syringe solution
次要结局
- Resuscitation time(From the end of the dressing change to the patient's Ramsay Sedation Scale was 1, assessed up to 10 minute.)
- SF-MPQ score after awakening(Within 15 minutes to 30 minutes after the patient wakes up)
- Proportion of patients taking fentanyl remedies(Within 5 minutes after the dressing change)
- Incidence of sedation-related complication(From the beginning of the medication to the end of the dressing change, assessed up to 30 minute.)
- Incidence of nausea and vomiting(1 days after dressing change)
- Burn physician satisfaction with the procedure(Within 5 minutes after the end of the dressing change)
- Incidence of early depression(3 days after dressing change)
- Patient satisfaction with dressing changes(30 minutes to 1 hour after the patient wakes up)
- Incidence of serious complications associated with burns(15 days after dressing change)
研究者
ZhiHeng Liu
Director, Head of Anesthesiology, Principal Investigator, Clinical Professor
Shenzhen Second People's Hospital