A Prospective Observational study on the efficacy and safety of low dose intravenous ketamine in refractory cancer pain in patients suffering from advanced cancer at SMS Medical College and Hospital, Jaipur
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- 1. To assess efficacy( in terms of changing NRS) of low dose
研究概览
简要总结
Cancer pain is a prevalent issue, with around 50.7% of patients experiencing it across all stages. Refractory cancer pain persists despite standard treatments like opioids and non-pharmacological methods, significantly impacting quality of life. Opioids are a cornerstone in pain management but can cause side effects, including opioid-induced hyperalgesia (OIH), where pain increases with higher doses.
Ketamine, at sub-anaesthetic doses, shows potential in managing such pain. By acting as an NMDA receptor antagonist, it addresses central sensitization, reverses opioid tolerance, and alleviates hyperalgesia and allodynia, making it a promising option for improving pain relief in cancer patients.
So, with this background of knowledge present study aims to assess the effectiveness and safety of low-dose intravenous ketamine in managing opioid-refractory cancer pain in individuals with advanced cancer disease.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Age between 18 and 65 years.
- •Registered in Palliative Medicine Department.
- •Suffering from a histologically diagnosed cancer.
- •Patients having nociceptive or neuropathic pain refractory to opioids,numerical rating score greater than 7/10
- •Patient giving written informed consent for this study.
- •Patient having more than 180 mg morphine in 24 hours with inadequate pain relief.
排除标准
- •History of allergy or intolerance to ketamine.
- •History of uncontrolled hypertension, heart disease, liver and renal disease, glaucoma, primary and malignant brain lesions.
- •Patients on psychiatric treatment
- •Subjects scheduled to receive radiotherapy (RT) to a site of pain during the study period, or who have received RT to a site of pain within 2 weeks before study entry.
- •Subjects scheduled to undergo surgical treatment during the study period are likely to affect pain.
- •Subjects on or starting chemotherapy if there is a significant expectation of that therapy affecting pain.
- •Patients are included in other study group.
结局指标
主要结局
1. To assess efficacy( in terms of changing NRS) of low dose
时间窗: 1. The first follow up will be done at 2nd week after discharge pain | intensity and dose of opioid. | 2. The second follow up will be done at 4th week after discharge | regarding pain intensity and dose of opioid
intravenous ketamine in opioid refractory cancer pain in patients
时间窗: 1. The first follow up will be done at 2nd week after discharge pain | intensity and dose of opioid. | 2. The second follow up will be done at 4th week after discharge | regarding pain intensity and dose of opioid
suffering from advanced cancer.
时间窗: 1. The first follow up will be done at 2nd week after discharge pain | intensity and dose of opioid. | 2. The second follow up will be done at 4th week after discharge | regarding pain intensity and dose of opioid
2. To assess safety (in terms of adverse effects )of low dose
时间窗: 1. The first follow up will be done at 2nd week after discharge pain | intensity and dose of opioid. | 2. The second follow up will be done at 4th week after discharge | regarding pain intensity and dose of opioid
suffering from advanced cancer
时间窗: 1. The first follow up will be done at 2nd week after discharge pain | intensity and dose of opioid. | 2. The second follow up will be done at 4th week after discharge | regarding pain intensity and dose of opioid
次要结局
- adverse events & sustainability of ketamine effect.(at time of discharge at second week & fourth week of discharge.)
研究者
DR DEEPINDER KAUR GHERA
SAWAI MAN SINGH MEDICAL COLLEGE AND ATTACHED HOSPITALS