Intravenous Infusion of Esketamine in Combination With Pregabalin and Duloxetine for Postherpetic Neuralgia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- the mean of daily pain scores
研究概览
简要总结
To assess the 1-week effects and safety of esketamine in combination with pregabalin and duloxetine to relieve pain in patients with postherpetic Neuralgia(PHN).
详细描述
The investigators aim to investigate whether or not esketamine combined with pregabalin and duloxetine to relieve pain in patients with PHN, and seek a rapid, effective and safe treatment for refractory patients with PHN
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages more than 18 years;
- •Pain present for more than 3 months after healing of a herpes zoster skin rash;
- •Has an average pain score of at least 4 on a Numeric Rating Scale (NRS, 0= no pain, 10= worst possible pain)；
- •Failed to respond to or tolerate the effective dose of pregabalin monotherapy.
排除标准
- •Obstructive sleep apnoea syndrome;
- •Those who receive interventional treatments;
- •A history of systemic immune diseases, organ transplantation, or cancers;
- •A history of severe cardiopulmonary, hepatic or renal dysfunction;
- •A history of schizophrenia, epilepsy, or myasthenia gravis, delirium;
- •Currently using monoamine oxidase inhibitors (MAOIs);
- •Having untreated angle-closure glaucoma;
- •Those suffering from increased intracranial pressure；
- •Comorbid hyperthyroidism or phaeochromocytoma;
- •Suspected or confirmed history of drug abuse;
- •Having contraindications to esketamine, pregabaline or duloxetine;
- •Communication difficulties;
- •Women who are preparing for pregnancy, in the pregnancy or lactation period.
研究组 & 干预措施
the esketamine group
In the esketamine group, in addition to receiving the combination of pregabalin and duloxetine, patients will also undergo a single intravenous infusion of esketamine. A total of 0.5 mg/kg of esketamine will be diluted in 50 mL of normal saline. The infusion will commence with an intravenous injection of 10 mg of esketamine over 1 minute, followed by a maintenance dose of 8 mg/h. The infusion rate will be adjusted based on the patients' tolerance levels.
干预措施: esketamine group (Drug)
the control group
In the control group, patients will receive pregabaline combined with duloxetine. Pregabaline will be administered at a dose of 50-75 mg, twice daily during the first 3 days of treatment, and increase to 300mg daily after 3-7days, then by an additional 150mg daily every 3-7 days as tolerated, up to a maximum daily dose of 600mg. Meanwhile, duloxetine will be prescribed at an initial daily dose of 30mg, and then gradually increased to 60 mg daily after one week if patients tolerate it well.
干预措施: control group (Drug)
结局指标
主要结局
the mean of daily pain scores
时间窗: during 1 week
the mean of daily pain scores collected during week 1 of treatment measured using the Numerical Pain Rating Scale (NRS,, 0 represents no pain, and 10 represents the most severe pain.A higher score indicates more severe pain).
次要结局
- Averaged weekly NRS score(1 week, 2 weeks, 3 weeks, and 1 month after treatment)
- percentages of patients having >50% reductions in 24-hour average pain severity during the first week(during the first week)
- the 12-item Short-Form Health Survey (SF-12) score(1 day, 3 days, 7 days, 2 weeks, 3 weeks, and 1 month after treatment)
- the Pittsburgh Sleep Quality Index (PSQI) score(1 day, 3 days, 7 days, 2 weeks, 3 weeks, and 1 month after treatment)
- the Patient Global Impression of Change scale (PGIC)(1 day, 3 days, 7 days, 2 weeks, 3 weeks, and 1 month after treatment)
- The Hospital Anxiety and Depression Scale (HADS)(1 day, 3 days, 7 days, 2 weeks, 3 weeks, and 1 month after treatment)
- Averaged weekly analgesic consumption(1 day, 3 days, 7 days, 2 weeks, 3 weeks, and 1 month after treatment)
- Safety assessments(0 day, 1 day, 3 days, 7 days, 2 weeks,3 weeks, and 1 month after treatment)
研究者
Fang Luo
The Director of Department of Pain Management
Beijing Tiantan Hospital