Comparison of fixed dose combination of Tramadol/Acetaminophen VS Codeine/Acetaminophen for management of mild-moderate pain in patients diagnosed with lung carcinoma - A Randomised Double Blinded Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Adequate pain relief of more than or equal to 60 percentage with the initiation of fixed dose combination of drugs
研究概览
简要总结
This is a randomized , double blinded parallel group single-centre trail comparing fixed dose combination of tramadol/acetaminophen vs Codeine/ Acetaminophen for management of mild-moderate pain in patients with lung carcinoma. The primary outcome is 60 percentage or more pain relief with initiation of fixed dose combination, assessed at 1 st day , 7th day and 14th day. The secondary outcome is to assess the side effect profile at the same time periods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult who are aged more than 18 years who have lung cancer irrespective of the stage who consent for the study.
- •Pain score should be less than 7 in NRS and the patient should have no cognitive impairment.
排除标准
- •Patients with cancer whose age is less than 18 and those with lung cancer who do not consent for the study.
- •Previous opioid users will be excluded.
结局指标
主要结局
Adequate pain relief of more than or equal to 60 percentage with the initiation of fixed dose combination of drugs
时间窗: The patients will be interviewed after the first day and on the 7th day and then on the 14th day of drug initiation
次要结局
- SIDE EFFECT ASSESSMENT(DAY ONE. DAY 7, DAY 14)
研究者
SHARUN MATHEW JOHN
BASAVATARAKAM INDO AMERICAN CANCER HOSPITAL AND RESEARCH INSTITUTE