Assessment of Three Regimens of Ketamine Infusion in Complex Regional Pain Syndrome: Randomized Prospective Comparative Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- degree of chronic pain reduction
研究概览
简要总结
To evaluate the efficacy of three regimens of sub anesthetic dose of ketamine infusion in relieving chronic refractory pain in patients with complex regional pain syndrome
详细描述
Ketamine N-methyl-D-aspartate (NMDA) receptor blocker that has recently been studied for its analgesic effect is a phencyclidine or phenyl cyclohexyl piperidine (PCP) derivative that initially became commercially available for human use in 1970 as a rapid-acting intravenous (IV) anesthetic. It is currently classified by the Food and Drug Administration (FDA) as an anesthetic induction agent in doses ranging from 1 to 4.5 mg/kg.
Ketamine has proven to be a desirable drug, despite of its induction dissociative effects and abuse potential. It is favorable due to its short half-life and lack of clinically significant respiratory depression. In addition to its anesthetic effects, ketamine has analgesic, anti-inflammatory, and antidepressant activities.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged more than 21 years old of both sexes with American Standards Association I ,II.
- •Patients diagnosed as ( CRPS) based on Budapest criteria
- •The average daily pain intensity required on (NRS) is 7 or more for at least 3 months despite of standard therapy which includes: (pharmacologic therapy as non steroidal anti- inflammatory drugs (NSAIDs), antiepileptic (AEDs), antidepressants), as well as physical therapy and psychiatric care
排除标准
- •patients refusal
- •Patients with unstable psychological or psychiatric conditions, including : untreated bipolar disorder, post-traumatic stress disorder, major depression , severe personality disorder and psychotic illness.
- •Patients have recently undergone major interventional pain procedures, such as nerve blocks or implantable therapies within 3 months of enrollment.
- •Patients with known drug dependency or substance use disorder specifically related to ketamine or other psycho-stimulant drugs.
- •Patients with previous severe reactions, contraindication or allergy to ketamine.
- •Patients with cardiovascular disease (hypertension, arrhythmia), hepatic, renal or other organ impairment.
研究组 & 干预措施
Group A
patients will receive ketamine parenteral infusion (0.35 mg/kg/h or maximum 24mg/h) at post anesthetic care unit(PACU) over 6 hours for 3days
干预措施: Ketamine (Drug)
Group B
patients will receive ketamine parenteral infusion (0.35 mg/kg/h or maximum 24mg/h ) at post anesthetic care unit(PACU) over 6 hours for 5 days .
干预措施: Ketamine (Drug)
Group C
patients will receive ketamine parenteral infusion (0.35 mg/kg/h or maximum 24mg/h ) at post anesthetic care unit(PACU) over 6 hours for 7 days
干预措施: Ketamine (Drug)
结局指标
主要结局
degree of chronic pain reduction
时间窗: up to 3 months post infusion
using Brief Pain Inventory short form (BPI-SF) questionnaire. It is a 9 item self-administered questionnaire used to evaluate the severity of a patient's pain and the impact of this pain on the patient's daily functioning. The patient is asked to rate their worst, least, average, and current pain intensity, list current treatments and their perceived effectiveness, and rate the degree that pain interferes with general activity, mood, walking ability, normal work, relations with other persons, sleep, and enjoyment of life on a 10 point scale.
次要结局
- Side effects(up to 3 months post infusion)
- Reduction of the degree of chronic pain score(up to 3 months post infusion)
研究者
Aml Magdy Abo Elsafa
resident of anesthesiology, surgical intensive care and pain medicine
Tanta University