Does the Addition of Dexmedetomidine to Morphine Improve the Treatment of Pain in Patients With Metastatic Cancer? A Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 主要终点
- Pain score
研究概览
简要总结
Pain is a common symptom in patients nearing the end of life. Its prevalence varies between 30 and 75%. Nowadays, morphine is the most used molecule as first line treatment of moderate to severe pain. However, this molecule, considering its side effects, may contribute in part to the discomfort of these patients and may increase the pre-existing agitation or delirium. There is therefore a need to find new agents, other than morphine, for pain control at the end of life, without the limitations that the morphine molecule has. The author reviewed the literature on the role of dexmedetomidine in the treatment of refractory symptoms in palliative care, including pain. It is an agonist of the adrenergic alpha 2 receptor having a sedative, analgesic action and a morphine sparing effect demonstrated postoperatively.
This study aims primarily at demonstrating that dexmedetomidine has a beneficial role in the treatment of pain in patients with metastatic cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any painful patient with metastatic cancer
- •Whatever type of pain: nociceptive, neuropathic, or mixed
- •Age > 18 and <75 years
- •Patient under analgesic Tier III treatment: with moderate to severe pain and not relieved by non-opioid conventional treatment
- •Patient cooperating capable of responding to the pain assessment by providing a number from 0 to 10 at the VAS
- •Patient providing his explicit consent to participate in the study before inclusion (regardless of his inclusion in C or D Group)
- •Patients with systolic blood pressure (SBP) ≥ 100 mmHg and a diastolic blood pressure (DBP) ≥ 50 mmHg
- •Patients with a heart rate ≥ 50/min
排除标准
- •Patient refusal to participate in the study or patient unable to give consent
- •Age <18 or > 75 years
- •Comatose uncooperative patient unable to respond to the assessment of pain by VAS
- •Hypotensive patients with SBP < 100 mmHg and DBP < 60 mmHg or bradycardic with a heart rate < 50/min
- •Patient with a heart rhythm disorder, or a disorder of the atrial-ventricular conduction
- •Patients under beta-blocker
- •Patient with heart failure with an ejection fraction < 40%
- •Patient suffering from allergy or previous intolerance to morphine or dexmedetomidine
- •Patient with renal impairment with a creatinine clearance <3 0ml/min/1.73m2, or patient under hemodialysis or peritoneal dialysis.
- •Patient with severe hepatic impairment with Child-Pugh score at C.
研究组 & 干预措施
Dexmedetomidine
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Pain score
时间窗: 48 hours
The visual analogue score is used to asses for pain score, the scale varies between 0 and 10 where 0 is no pain and 10 is worst pain encountered
Morphine consumption
时间窗: 48 hours
次要结局
未报告次要终点
研究者
Nicole Naccache
Assistant professor
Hotel Dieu de France Hospital