Comparison of Oral Morphine Versus Nasal Ketamine Spray With Chitosan in Cancer Pain Outpatients
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Time to onset of action of intranasal ketamine compared with morphine drops
研究概览
简要总结
34 adult (>18 years) cancer pain outpatients with Opioid base therapy because of pain and breakthrough pain or extreme pain on movement will be included in this prospective, randomized, double-blind crossover study.
Over a period of 3 weeks patients will go through 3 treatment arms, each one lasting one week: Group A receives morphine drops and Placebo spray, Group B receives ketamine/chitosan spray nasal and Placebo drops and Group C receives morphine drops and ketamine/chitosan spray nasal.
Primary endpoint is time to onset of action of intranasal ketamine compared with morphine drops. Secondary endpoint is the median numeric rating scale (NRS) improvement after using the spray or morphine or the combination of ketamine spray and morphine drops.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, 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
- •Cancer pain in outpatients with:
- •Opioid based therapy due to pain
- •Breakthrough pain or
- •Extreme pain on movement
- •Age >= 18 years
排除标准
- •Patients unable to give written informed consent
- •Patients unable to understand how to handle and document the use of the study medication
- •Known drug allergies or intolerance to ketamine
- •Known drug allergies or intolerance to morphine
- •Known allergy to crustacea or chitosan
- •Patients using snuff at a regular basis
- •Recreational drug addiction or abuse
- •Serious intranasal or epipharyngeal Problems (Septum wall defects, cancer)
- •Mental/psychiatric disorder
- •Patients with renal failure (clearance < 30 ml/min)
- •Pregnancy and breast feeding mothers
- •Patients not understanding German
- •Patient having arterial hypertonia with measured values > 180/95
研究组 & 干预措施
morphine drops solo and placebo spray
morphine 2% drops
- daily fixed dose of morphine equivalents < 100 mg, 0.2 mg/kg Body weight morphine drops every hour in reserve due to international Standards
- daily fixed dose of morphine equivalents =/> 100 mg, 15% of the fixed daily dose in morphine drops every hour in reserve due to international standards
干预措施: Morphine (Drug)
morphine drops solo and placebo spray
morphine 2% drops
- daily fixed dose of morphine equivalents < 100 mg, 0.2 mg/kg Body weight morphine drops every hour in reserve due to international Standards
- daily fixed dose of morphine equivalents =/> 100 mg, 15% of the fixed daily dose in morphine drops every hour in reserve due to international standards
干预措施: Placebo (Drug)
ketamine/chitosan spray nasal and placebo drops
5 mg ketamine all 5 minutes, maximal 4 times an hour
干预措施: Ketamine (Drug)
ketamine/chitosan spray nasal and placebo drops
5 mg ketamine all 5 minutes, maximal 4 times an hour
干预措施: Placebo (Drug)
ketamine/chitosan spray nasal and placebo drops
5 mg ketamine all 5 minutes, maximal 4 times an hour
干预措施: Chitosan (Drug)
morphine drops and ketamine/chitosan spray nasal
see above
干预措施: Morphine (Drug)
morphine drops and ketamine/chitosan spray nasal
see above
干预措施: Ketamine (Drug)
morphine drops and ketamine/chitosan spray nasal
see above
干预措施: Chitosan (Drug)
结局指标
主要结局
Time to onset of action of intranasal ketamine compared with morphine drops
时间窗: 45 minutes
次要结局
- Median NRS improvement after using the spray or morphine or the combination of ketamine spray and morphine drops(after 5, 10, 15, 20, 45 minutes)
- Total amount of delivered applications of ketamine or morphine in each study arm(3 weeks)
- Total amount of fixed and reserve opioid doses increase in each study arm(3 weeks)
- Assessment of Nausea, vomiting, itching, fatigue, hallucinations, Irritation of nasal mucosa(3 weeks)